Automotive recall numbers from 2006-2008

Recall_Number
Z-0863-06
Z-0005-2007
Z-0859-06
Z-0201-2007
Z-0220-2007
Z-0444-06
Z-1413-06
Z-1522-06
Z-0718-06
Z-1453-06
Z-0861-06
Z-0547-06
Z-1294-06
Z-0535-06
Z-1299-06
Z-0290-2007
Z-1296-06
Z-0546-06
Z-0411-06
Z-0308-2007
Z-1386-06
Z-1298-06
Z-0514-06
Z-0047-2007
Z-1292-06
Z-0893-06
Z-1103-06
Z-0300-2007
Z-1387-06
Z-1297-06
Z-0623-06
Z-1508-06
Z-0825-06
Z-0269-2007
Z-0035-2007
Z-0517-06
Z-0152-2007
Z-1195-06
Z-1106-06
Z-0183-2007
Z-0184-2007
Z-0258-2007
Date
May-16-2006
Oct-03-2006
May-10-2006
Nov-21-2006
Nov-28-2006
Jan-31-2006
Sep-12-2006
Sep-23-2006
Apr-07-2006
Aug-29-2006
May-27-2006
Feb-23-2006
Sep-28-2006
Feb-18-2006
Sep-28-2006
Dec-19-2006
Sep-28-2006
Feb-22-2006
Jan-28-2006
Dec-27-2006
Aug-10-2006
Sep-28-2006
Feb-14-2006
Oct-19-2006
Jul-27-2006
May-23-2006
Jun-10-2006
Dec-19-2006
Aug-10-2006
Sep-28-2006
Mar-02-2006
Sep-19-2006
May-02-2006
Dec-16-2006
Oct-12-2006
Feb-16-2006
Nov-04-2006
Jul-08-2006
Jun-22-2006
Nov-16-2006
Nov-16-2006
Dec-15-2006
Year
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
Z-0860-06
Z-0002-2007
Z-0389-06
Z-1306-06
Z-0322-2007
Z-1250-06
Z-0304-2007
Z-0352-06
Z-0042-2007
Z-1259-06
Z-0438-06
Z-0857-06
Z-0581-06
Z-0041-2007
Z-0565-06
Z-1445-06
Z-0033-2007
Z-0808-06
Z-1172-06
Z-0900-06
Z-0398-06
Z-0576-06
Z-0902-06
Z-1286-06
Z-1235-06
Z-0911-06
Z-0311-2007
Z-0905-06
Z-1325-06
Z-0853-06
Z-1256-06
Z-0364-06+A25
Z-0417-06
Z-0682-06
Z-0298-2007
Z-1355-06
Z-1356-06
Z-1357-06
Z-1360-06
Z-1367-06
Z-1487-06
Z-1518-06
Z-0601-06
May-11-2006
Oct-12-2006
Jan-12-2006
Aug-03-2006
Dec-30-2006
Jul-22-2006
Dec-19-2006
Jan-06-2006
Oct-14-2006
Jul-26-2006
Jan-25-2006
May-09-2006
Feb-28-2006
Oct-25-2006
Mar-03-2006
Aug-26-2006
Oct-12-2006
May-02-2006
Jun-27-2006
May-25-2006
Jan-18-2006
Feb-28-2006
May-25-2006
Jul-27-2006
Jul-13-2006
May-31-2006
Dec-27-2006
May-25-2006
Aug-03-2006
May-06-2006
Jul-27-2006
Jan-07-2006
Jan-24-2006
Mar-29-2006
Dec-19-2006
Aug-05-2006
Aug-05-2006
Aug-05-2006
Aug-05-2006
Aug-05-2006
Sep-12-2006
Sep-23-2006
Mar-09-2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
Z-0295-2007
Z-1310-06
Z-0055-2007
Z-1502-06
Z-0387-06
Z-0353-06
Z-0515-06
Z-0378-06
Z-1266-06
Z-0070-2007
Z-1317-06
Z-0910-06
Z-1245-06
Z-1440-06
Z-1464-06
Z-0197-2007
Z-1147-06
Z-0889-06
Z-0054-2007
Z-0029-2007
Z-1262-06
Z-0809-06
Z-1105-06
Z-1268-06
Z-1516-06
Z-0854-06
Z-0380-06
Z-0622-06
Z-0219-2007
Z-1252-06
Z-1353-06
Z-0713-06
Z-0529-06
Z-1303-06
Z-0831-06
Z-0437-06
Z-0399-06
Z-0358-06
Z-0520-06
Z-0161-2007
Z-0797-06
Z-0757-06
Z-1305-06
Dec-19-2006
Aug-02-2006
Oct-20-2006
Sep-13-2006
Jan-11-2006
Jan-06-2006
Feb-14-2006
Jan-11-2006
Jul-27-2006
Oct-25-2006
Aug-02-2006
May-31-2006
Jul-18-2006
Aug-26-2006
Aug-29-2006
Nov-21-2006
Jun-21-2006
May-19-2006
Oct-21-2006
Oct-12-2006
Jul-27-2006
Apr-26-2006
Jun-10-2006
Jul-27-2006
Sep-23-2006
May-09-2006
Jan-11-2006
Mar-15-2006
Nov-28-2006
Jul-26-2006
Aug-03-2006
Apr-06-2006
Feb-16-2006
Sep-30-2006
May-03-2006
Jan-24-2006
Jan-18-2006
Jan-06-2006
Feb-14-2006
Nov-08-2006
Apr-26-2006
Apr-11-2006
Jul-28-2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
Z-0554-06
Z-0862-06
Z-1375-06
Z-0223-2007
Z-1161-06
Z-0165-2007
Z-0795-06
Z-0856-06
Z-1401-06
Z-0557-06
Z-1398-06
Z-1255-06
Z-1079-06
Z-1078-06
Z-0314-2007
Z-1466-06
Z-1437-06
Z-0821-06
Z-0069-2007
Z-0533-06
Z-0115-2007
Z-1104-06
Z-1243-06
Z-0532-06
Z-0855-06
Z-0061-2008
Z-0988-2007
Z-0886-2007
Z-0048-2008
Z-0047-2008
Z-1192-2007
Z-0598-2007
Z-0761-2007
Z-0840-2007
Z-0286-2008
Z-1203-2007
Z-0287-2008
Z-0602-2007
Z-1242-2007
Z-0872-2007
Z-1007-2007
Z-0483-2007
Z-1053-2007
Mar-31-2006
May-16-2006
Aug-05-2006
Nov-29-2006
Jun-22-2006
Nov-14-2006
Apr-26-2006
May-09-2006
Aug-11-2006
Feb-23-2006
Aug-10-2006
Jul-27-2006
Jun-03-2006
Jun-03-2006
Dec-27-2006
Aug-31-2006
Aug-30-2006
Apr-27-2006
Oct-25-2006
Mar-29-2006
Oct-28-2006
Jun-10-2006
Jul-27-2006
Feb-23-2006
May-09-2006
Oct-18-2007
Jul-03-2007
Jul-04-2007
Nov-24-2007
Nov-24-2007
Sep-19-2007
Jun-30-2007
Apr-20-2007
Jun-07-2007
Dec-20-2007
Sep-07-2007
Dec-20-2007
Jun-30-2007
Sep-26-2007
Jun-06-2007
Jul-07-2007
Jan-11-2007
Jul-11-2007
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
Z-0641-2007
Z-0760-2007
Z-0376-2007
Z-1002-2007
Z-1005-2007
Z-0416-2007
Z-0343-2007
Z-0304-2008
Z-0929-2007
Z-0323-2008
Z-0075-2008
Z-0322-2008
Z-0687-2007
Z-1090-2007
Z-0395-2007
Z-0321-2008
Z-0129-2008
Z-1006-2007
Z-0491-2007
Z-0600-2007
Z-0492-2007
Z-0039-2008
Z-0709-2007
Z-0342-2007
Z-0064-2008
Z-0372-2007
Z-0059-2008
Z-0356-2008
Z-0848-2007
Z-0056-2008
Z-1089-2007
Z-1245-2007
Z-0890-2007
Z-0660-2007
Z-0296-2008
Z-1223-2007
Z-0854-2007
Z-1001-2007
Z-0470-2007
Z-0253-2008
Z-0081-2008
Z-1095-2007
Z-0380-2007
Mar-22-2007
Apr-24-2007
Jan-25-2007
Jul-07-2007
Jul-07-2007
Feb-07-2007
Jan-19-2007
Dec-19-2007
Jun-30-2007
Dec-01-2007
Nov-08-2007
Dec-01-2007
Mar-31-2007
Jul-23-2007
Feb-01-2007
Dec-01-2007
Nov-06-2007
Jul-03-2007
Feb-14-2007
Jun-30-2007
Feb-14-2007
Oct-11-2007
May-23-2007
Jan-25-2007
Nov-03-2007
Jan-25-2007
Nov-10-2007
Dec-08-2007
Jun-30-2007
Oct-13-2007
Jul-23-2007
Sep-26-2007
Jun-05-2007
Mar-28-2007
Nov-27-2007
Sep-19-2007
Jun-05-2007
Jul-03-2007
Jan-13-2007
Nov-17-2007
Nov-06-2007
Jul-24-2007
Feb-15-2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
Z-0700-2007
Z-0718-2007
Z-0041-2008
Z-0768-2007
Z-0671-2007
Z-0773-2007
Z-1000-2007
Z-0891-2007
Z-0999-2007
Z-1170-2007
Z-0262-2008
Z-0366-2008
Z-0367-2008
Z-0265-2008
Z-0312-2008
Z-0951-2007
Z-0146-2008
Z-0566-2007
Z-0437-2007
Z-0439-2007
Z-0040-2008
Z-0037-2008
Z-1132-2007
Z-0480-2007
Z-1212-2007
Z-0523-2007
Z-0705-2007
Z-0422-2007
Z-0507-2007
Z-0814-2007
Z-1167-2007
Z-0638-2007
Z-0925-2007
Z-0494-2007
Z-0168-2008
Z-0436-2007
Z-0987-2007
Z-0448-2007
Z-0113-2008
Z-0180-2008
Z-0432-2007
Z-0329-2008
Z-0784-2007
Mar-31-2007
Apr-05-2007
Oct-11-2007
Apr-26-2007
Mar-29-2007
May-03-2007
Jul-07-2007
Jun-06-2007
Jul-07-2007
Aug-18-2007
Nov-24-2007
Dec-29-2007
Dec-29-2007
Nov-28-2007
Dec-22-2007
Jun-19-2007
Nov-07-2007
Mar-06-2007
Feb-14-2007
Feb-14-2007
Oct-12-2007
Oct-11-2007
Aug-07-2007
Jan-11-2007
Sep-25-2007
Feb-27-2007
Apr-06-2007
Feb-17-2007
Feb-15-2007
May-18-2007
Aug-16-2007
Mar-20-2007
Jun-09-2007
Feb-14-2007
Nov-09-2007
Feb-14-2007
Jul-03-2007
Jan-09-2007
Nov-07-2007
Nov-21-2007
Feb-14-2007
Dec-07-2007
May-10-2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
Z-1244-2007
Z-0418-2007
Z-0555-2007
Z-0985-2007
Z-0397-2007
Z-0966-2007
Z-0433-2007
Z-0121-2008
Z-1043-2007
Z-0373-2007
Z-0905-2007
Z-0271-2008
Z-1201-2007
Z-1146-2007
Z-1145-2007
Z-0273-2008
Z-0704-2007
Z-0545-2007
Z-1147-2007
Z-1153-2007
Z-1152-2007
Z-1155-2007
Z-0978-2007
Z-1154-2007
Z-1182-2007
Z-1174-2007
Z-0652-2007
Z-0869-2007
Z-0181-2008
Z-0451-2008
Z-0148-2008
Z-0616-2007
Z-1075-2007
Z-0771-2007
Z-0381-2007
Z-0815-2007
Z-0364-2008
Z-0293-2008
Z-0989-2007
Z-0014-2007
Z-0636-2007
Z-0548-2007
Z-0213-2008
Sep-26-2007
Feb-08-2007
Sep-26-2007
Jun-27-2007
Feb-01-2007
Jul-04-2007
Feb-14-2007
Nov-07-2007
Jul-10-2007
Jan-25-2007
Jun-06-2007
Nov-29-2007
Aug-29-2007
Aug-08-2007
Aug-08-2007
Nov-29-2007
Mar-30-2007
Mar-01-2007
Aug-08-2007
Aug-08-2007
Aug-08-2007
Aug-09-2007
Jun-28-2007
Aug-08-2007
Sep-05-2007
Aug-22-2007
Mar-28-2007
Jun-05-2007
Nov-10-2007
Dec-11-2007
Dec-28-2007
Mar-13-2007
Jul-12-2007
May-05-2007
Feb-01-2007
May-18-2007
Dec-12-2007
Nov-27-2007
Jul-12-2007
Sep-26-2007
Mar-17-2007
Feb-23-2007
Nov-08-2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
2007
Z-0549-2007
Z-0686-2007
Z-1243-2007
Z-0294-2008
Z-1010-2007
Z-0257-2008
Z-0580-2007
Z-1091-2007
Z-1238-2007
Z-2388-2008
Z-0162-2009
Z-2435-2008
Z-1749-2008
Z-0119-2009
Z-0710-2008
Z-0294-2009
Z-1510-2008
Z-0728-2008
Z-0670-2008
Z-1473-2008
Z-0414-2009
Z-1710-2008
Z-1712-2008
Z-1464-2008
Z-0694-2008
Z-0020-2009
Z-1619-2008
Z-0324-2008
Z-2337-2008
Z-0152-2009
Z-0503-2009
Z-0445-2009
Z-1649-2008
Z-1693-2008
Z-1050-2008
Z-2389-2008
Z-0567-2008
Z-2452-2008
Z-0484-2009
Z-1188-2008
Z-0986-2008
Z-2209-2008
Z-1051-2008
Feb-23-2007
Mar-31-2007
Sep-25-2007
Nov-27-2007
Jul-03-2007
Nov-24-2007
Mar-08-2007
Jul-18-2007
Sep-27-2007
Sep-21-2008
Oct-27-2008
Sep-20-2008
Sep-01-2008
Oct-20-2008
Feb-05-2008
Nov-25-2008
Sep-19-2008
Feb-16-2008
Jul-03-2008
Jul-23-2008
Dec-10-2008
Jun-10-2008
Jun-10-2008
Aug-13-2008
Feb-05-2008
Oct-06-2008
Aug-15-2008
Jan-17-2008
Sep-25-2008
Oct-21-2008
Dec-16-2008
Dec-29-2008
Aug-25-2008
Sep-23-2008
Mar-29-2008
Sep-21-2008
Jan-31-2008
Sep-21-2008
Dec-02-2008
Jun-26-2008
May-14-2008
Sep-17-2008
Mar-18-2008
2007
2007
2007
2007
2007
2007
2007
2007
2007
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
Z-1692-2008
Z-1616-2008
Z-1711-2008
Z-2314-2008
Z-0496-2009
Z-2227-2008
Z-0205-2009
Z-1660-2008
Z-1526-2008
Z-2230-2008
Z-0531-2008
Z-2154-2008
Z-0126-2008
Z-2322-2008
Z-1320-2008
Z-1604-2008
Z-1656-2008
Z-1707-2008
Z-0203-2009
Z-0338-2009
Z-0204-2009
Z-0283-2009
Z-0087-2009
Z-1768-2008
Z-0214-2009
Z-1588-2008
Z-0152-2008
Z-1306-2008
Z-1242-2008
Z-0568-2008
Z-0958-2008
Z-1766-2008
Z-2180-2008
Z-1317-2008
Z-1644-2008
Z-1546-2008
Z-1373-2008
Z-2369-2008
Z-1309-2008
Z-1571-2008
Z-1895-2008
Z-0720-2008
Z-0976-2008
Sep-16-2008
May-21-2008
Jun-10-2008
Sep-20-2008
Dec-22-2008
Sep-11-2008
Oct-31-2008
Sep-16-2008
Aug-16-2008
Sep-11-2008
Jan-24-2008
Aug-26-2008
Jan-03-2008
Sep-20-2008
Aug-19-2008
Sep-23-2008
Sep-16-2008
Sep-29-2008
Nov-06-2008
Dec-16-2008
Nov-06-2008
Nov-07-2008
Oct-08-2008
Sep-04-2008
Nov-12-2008
Sep-11-2008
Feb-22-2008
Jul-01-2008
Jun-27-2008
Jan-29-2008
Apr-30-2008
Sep-02-2008
Sep-04-2008
Apr-08-2008
May-28-2008
May-28-2008
Jul-29-2008
Sep-18-2008
Aug-28-2008
Jul-24-2008
Sep-16-2008
Feb-15-2008
Apr-30-2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
Z-1769-2008
Z-0165-2009
Z-2095-2008
Z-0946-2008
Z-1905-2008
Z-1904-2008
Z-0960-2008
Z-0340-2009
Z-0280-2008
Z-1167-2008
Z-1218-2008
Z-0522-2009
Z-1776-2008
Z-0519-2008
Z-2468-2008
Z-2231-2008
Z-1161-2008
Z-2404-2008
Z-1695-2008
Z-2212-2008
Z-0570-2008
Z-1525-2008
Z-2037-2008
Z-1906-2008
Z-1243-2008
Z-2308-2008
Z-1394-2008
Z-2286-2008
Z-1307-2008
Z-2203-2008
Z-1316-2008
Z-0088-2009
Z-0660-2008
Z-2225-2008
Z-0368-2008
Z-1104-2008
Z-0460-2009
Z-2184-2008
Z-2016-2008
Z-0112-2009
Z-1882-2008
Z-0207-2009
Z-0297-2008
Aug-20-2008
Oct-22-2008
Sep-17-2008
Mar-07-2008
Sep-16-2008
Sep-16-2008
Feb-27-2008
Nov-21-2008
Feb-01-2008
Jun-28-2008
Jun-25-2008
Dec-31-2008
Aug-27-2008
Jan-17-2008
Sep-29-2008
Sep-11-2008
Jun-24-2008
Sep-22-2008
Aug-20-2008
Sep-19-2008
Mar-04-2008
Aug-16-2008
Jul-30-2008
Sep-16-2008
Sep-11-2008
Sep-17-2008
Apr-02-2008
Sep-17-2008
Jul-02-2008
Sep-16-2008
Sep-11-2008
Oct-07-2008
Jan-31-2008
Sep-11-2008
Sep-29-2008
May-01-2008
Dec-13-2008
Sep-17-2008
Jul-11-2008
Oct-15-2008
Sep-25-2008
Oct-31-2008
Jan-09-2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
Z-2053-2008
Z-0690-2008
Z-0150-2008
Z-2329-2008
Z-0365-2008
Z-2196-2008
Z-0195-2009
Z-0213-2009
Z-1442-2008
Z-1518-2008
Z-0661-2008
Z-1107-2004
Z-2459-2008
Z-0124-2008
Z-0136-2009
Z-2194-2008
Z-1643-2008
Z-2137-2008
Z-1827-2008
Z-1752-2008
Z-0592-2008
Z-2211-2008
Z-1825-2008
Z-2183-2008
Z-2463-2008
Z-2346-2008
Z-1141-2008
Z-2195-2008
Z-1826-2008
Z-0249-2008
Z-0086-2009
Z-1754-2008
Z-2310-2008
Z-0079-2008
Z-1245-2008
Z-1891-2008
Z-1516-2008
Z-1540-2008
Z-0324-2009
Z-1822-2008
Z-0462-2008
Z-2204-2008
Z-2056-2008
Sep-16-2008
Jan-31-2008
Jan-17-2008
Sep-22-2008
Jan-23-2008
Jun-28-2008
Nov-12-2008
Nov-05-2008
Aug-15-2008
Sep-30-2008
Apr-24-2008
Feb-15-2008
Sep-23-2008
Jan-30-2008
Nov-04-2008
Sep-04-2008
Aug-24-2008
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Trade_Name
Recall_Class
ac death (SCD). Cardiac resynchronization therapy is for the treatment
3
of heart failure (HF) and uses b
er Navigation System; eNlite System with Dell laptop computer model
2
D800; Stryker # 7700-300-000.
ries. - Cool-tip RF Generator; for use in percutaneous; laparoscopic;2 intraoperative coagulation and abl
tex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer
2
which delivers the anesthetic
ation DeviceModel IV - product code 5000230 Model ID; product code
2 5000330Konica Minolta Medical &
L 60015 U.S.A.; Made in Singapore; product codes 2M8151; 2M8151R;
1 BRM8151(Brazilian Portugese); D
setronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001.
1
ter; manufactured by KYMCO; Kaohsiung; Taiwan for Medline Industries;
3
Inc.; One Medline Place; Mude
ee navigation trackers. - AxiEM EM Knee Kit; and associated workstation.
3
oring System (Base Unit) 391-876 (affected device) CompactFlash 3cards: 914-698 (Defective Device Co
tiva System is an implantable; multiprogrammable system that delivers
3
electrical stimulation to select
LIFEPAK CR Plus - LIFEPAK CR Plus defibrillator
2
Guidant.--The NEXUS I Ultra pacemakers are multiprogrammable pacemakers
2
from Intermedics. Guidan
le pulse generators (IPGs) Dual Chamber Rate Responsive Pacemaker;
2
models SDR203; SDR303; SDR3
uantities Distributed by model are as follows: VITALITY model 18702= 40; model 1871 = 1; model T125
als that are transmitted to the brain. These signals are delivered from
2
the neurostimulator to the brain
ble pacemakers from Intermedics. Guidant Corporation; Cardiac Rhythm
2
Management; 4100 Hamline
LIFEPAK 500 - LIFEPAK 500 automated external defibrillator (AED)2
M9832R; and Sabratek 6060 Homerun Infusion Pumps; product codes
2 606000; 606000-40; 606000-40L
al HeartStart FR2+ Automated External Defibrillator - HeartStart FR2+
2 Defibrillator
s - Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers; ABL-700
2
Series; manufactured from 8/1
CONTAK RENEWAL TR2 devices are not available in the US. Quantities
2
Distributed by model are as fo
5016; 135028; 135029; 936400; 936400BLU. Microlab AT+ and Microlab
2
AT+2; part numbers 142000;
5852 and Power Supply Field Replacement Unit (FRU) PN; Continuous
2 Ventilator/Continuous Ventilator w
also offer a wide variety of antitachycardia pacing schemes to terminate
2
slower; more stable ventricula
High Frequency Ventilator - Life Pulse High Frequency Ventilator (HFV)
2
gnetic Resonance Imaging Device - Hitachi Altaire Magnetic Resonance
2
Imaging System
rface; an SpO2 probe interface; display of patient and waveform data
2 via an EL panel; power status LED
ers. - Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzers; ABL-800
2
series; manufactured from 8/2
th gaseous ethylene oxide. Guidant Corporation; Cardiac Rhythm Management;
2
4100 Hamline Avenue
9300A (Automatic). Cardiac Science AEDs are manufactured by: Manufacturing:
2
Cardiac Science; Inc.
ctrosurgical unit; REF 60-8005-SYS; 60-8015-SYS; 60-8018-SYS; 60-8005-001;
2
60-8005-003; Conmed
Ventricular tachyarrhythmia therapy is for the treatment of ventricular
2 tachycardia (VT) and ventricular
NTAK RENEWAL 4 RF (model H230); and CONTAK RENEWAL 4 RF HE2 (model H239) cardiac resynchroniz
s - SmartSuction Harmony Powered Suction DeviceModel Number: 2HAR-E-115-US
nd sidestream gas analyzer designed to measure the concentration2 of carbon dioxide in a gas mixture;
tachi Echelon Magnetic Resonance Imaging System; Serial Number:
2 V-001; equipped with CTL coil typ
efibrillator; a portable; 12V internal battery powered defibrillator; Manufactured
1
by MRL Inc.; A Welch A
2V internal battery powered defibrillator; Manufactured by MRL Inc.;
1 A Welch Allyn Company; 1000 Asb
Philips - M3001A Philips Multi Measurement Server (MMS)
2
FAST Sp02 and Pulse Oximetry Nellcor OxiMax Compatible used with
2 the IntelliVue or M3/M4 patient m
le (Part # 3006314) for use with Abbott/Hospira IBP Transducer b)2Invasive Blood Pressure Interface C
an in vitro diagnostic kit consisting of microparticles; conjugate; assay

3
diluent; pre-treatment 1; pre-tre
r (PRM). A portable cardiac rhythm management system designed3to be used with Guidant implantabl
pira brand Plum A+3 I.V. Infusion Pump; List No. 12348-04;Infusion2pump is a multi-function fluid delive
Harbor Bay Pwky.Alameda; CA 94502.Manufactured by: Flextronics2International; Long Jing Industrial E
ion System 1; 100V -120V; 15 A (circuit breaker); 50/60 Hz (20A power
2
source required) base; Model 80
ntilator (Software Version 2.2xS) Product is distributed by Hamilton2Medical; Inc.; 4990 Energy Way;Ren
grated treatment console versions 8.0.15 and below (excluding v7.0.31)
2
and all Varis Non-Varian Treatm
Centricity CR SP1001 and Centricity CR SP 100; image digitizer; components
2
in Agfa''s computed radio
ystem - OEC 9900 Elite Fluoroscopy System; Catalog No. 887208 and
2 887210; GE OEC Medical System
00 with UPS); 6605627 (TN; 5 CLR; FC500 (100V)); 6605628 (TN; 52CLR; FC500 (120V)) ; 6605629 (TN;
Arcadis Orbic - Arcadis Orbic Mobile X-Ray System
2
neshesia Delivery Unit - Datex-Ohmeda S/5 Anesthesia Delivery Unit
2 (ADU)
Allura Xper FD10/10 - Allura Xper FD10/10 x-ray system
2
system. - GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation;GE
2
OEC Medical Systems
00 D - AUDICOR 200 D Inovise Part Number 30047 (console part number
2
20158).
Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE;
2 Rev. 8 and 12864051DEL; Rev. 8
- IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)
2
ceptance of patient settings and for the display of alarm conditions.
1 PL VC I provides the following type
ProV with software versions 4.0.0; 4.0.1; 4.0.2; 4.0.3; 4.0.4; 4.0.5; 5.00;
3
5.0.1. The device is a general-p
20; SYNCHRON LX 20 PROClinical Systems; Operating Software Version
3
4.5; Part Number: A23724 In
000 System Software; Version 2.11; Product List/Model #5F48-12; distributed
3
by Abbot Laboratories; Ir
- Stat Profile Critical Care (CCX) Analyzer Catalog Number: 35942
3
icel DxC 600/800 SYNCHRON Clinical Systems; Operating Software3Version 1.0 and 1.2; Part Number: A
100V -120V; 15 A (circuit breaker); 50/60 Hz (20A power source required);
3
Models 801763 and 801763
KinetDx - KinetDx 4.0 Ultrasound Image Management System. 3
aker performance based on electrocardiographic measurements; either
3
taken directly from the patient
3
Neurostimulator. The Restore Neurostimulator is an implanted; rechargeable
3
neurostimulator which p
as analyzer - ABL800 Series Blood Gas Analyzer equipped with Software
3
Version 5.21.
on System; consisting of GeneChip 3000Dx scanner with autoloader;
3 FS450Dx fluidics station and GCO
4.5 Systems; used in the acceptance; transfer; display; storage and
3 digital processing of medical imag
celerators software package called LANTIS. The MedOnc module option
2
is distributed with all LANTIS so
brand Accu-Chek Aviva Care Kit; Catalog number 04528280001. (Distributed
2
within the U.S.)
er 05060298; All RapidLab 1200 Systems with Software Versions 1.0;
2 1.01; or 1.02. --- Common Name:
SR Model 5172; Identity DR Model 5370; & Identity XL DR Model 5376;
2
Pulse Generators (pacemakers
model number 870; Ref. no. 03002531001 with meter model number
2 33304510; Ref. no. 03002531001
EK Advantage Blood Glucose Meter; Cat. No. 2137500; Ref. no. 0385633001
2
with meter model no. 768
Advantage Blood Glucose Meter; Cat. No. 3332586; Ref. no. 03332586001
2
with meter model no. 21389
it) 100- value memory with time and date; Not for Retail Sale; Cat.2No. 3000389; Ref no. 03000389001
tomated Data Management; contents Accu-Chek Advantage repalcement
2
Meter and module; cat. no. 4
urement Server (MMS)/Multimeasurement Server; physiological patient
2
monitoring system.Model: M300
ystem - UniCel Dxl 800 Access Immunoassay Systems Wash Buffer;
2 Part Number 8547197 Wash Buffer
CA3 - Hospira LifeCare PCA3 Infusion System Software; versions 4.08
2 and 4.09
LIFEPAK 20 - LIFEPAK 20 automatic external defibrillator

2
ANCE MONITORS)with software release 5.3 or earlier only. Patient monitor
2
which measures cardiac out
tem infrastructure; -The receivers; -The receiver subsystem; -A computer
2
platform running the Apex
LIFEPAK - LIFEPAK 20 external defibrillator/monitor
2
- LOCIQ Book System models: 2399921; 2399923; 2349933; 2349934
2
and 2349935
07; 2.0.210 SU1; 3.0.229) ADC QS and Centricity CR Online Processing
2
Software (version 2.x)
version 5.n - Babylog 8000 plus with software version 5.n. Neonatal
2 Respirator-Continuous Ventilator
Instrumentation Laboratory - GEM PREMIER 3000
2
rumo Advanced Perfusion System 4 inch diameter Roller Pump; Model
2 801040.
yngo Imaging; picture archiving and communications system. Model
2 number 7502029
e & Metabolyte Analyzers - Blood Gas and Co-Ox Electrolyte & Metabolyte
2
Analyzer; ABL-700 series.
air; Airis Elite; AIRIS II MRI System - Magnetic Resonance Imaging Device
2
ogy Analyzer - Coulter LH500 Hematology Analyzer: Part Numbers 2178832; 178833; 178834
0/800PRO Synchron Clinical Systems ; Part Numbers: A20463-Software
2
version 1.0; A27331-Software ve
tems; Model 1245 - Blood gases; electrolyte and blood pH test system;
2
Bayer HealthCare LLC; Diagnos
try System - Cytomics FC 500 Flow Cytometry System with CXP Software
2
Versions 2.0 & 2.1
- LADARVision Excimer Laser System.
2
nded Brilliance Workspace Imaging Workstation. An independent diagnostic
2
viewing and processing wo
etwork infrastructure; A computer platform running the ApexPro Telemetry
2
Application and a computer
000 and AIRIS Magnetic Resonance Imaging Systems; Software Versions:
2
V7.0A to V7.0J.
ment System Software Version 2.42 (Stand-alone software package)2 for the Radiance STAT Analyzer Ma
hic X-Ray System - AXIOM Artis X-ray systems running software versions
2
VB11K and VB22G
netic resonance imaging devices - MRP-7000; AIRIS Magnetic Resonance
2
Imaging Systems
1019110; versions up to and including 1.62; for the GammaMedplus
2 radionuclide applicator system; fo
ADVIA Centaur CP System; Automated Immunoassay Analyzer; Part2/Catalogue Number 086-A001.
n for Advantage Windows Workstation with Volume View CT Colonography/Navigator
2
2 software. (Versi
ytomics FC500 with CXP Software - Cytomics FC500 withCXP Software
2
Synapse Software Versions 3.1.0 and 3.1.1 used witth the Fuji Synapse
2
PACS
Modality Workstation; Computed Radiography System (Software versions
2
NX 1.0.2402 and NX 1.0.240
used in pathology labs to track and report specimens and diagnostic
2 results. Releases 1.2; 2.1; and 2.
on Family (for the manipulation and displaying of x-ray images) with
2 Multi Planar Reformat (MPR) Optio
asound systems (MicroMaxx; TITAN; and SonoSite180PLUS). This software
2
generates a report with the
YAG; LightSheer and Universal IPL; Manufactured by Lumenis; Ltd; 213 Hayetzira Street; Yokneam Indus
RUS Software - RUS Tool Version Software
2
l Study v.2.0 - HD Module; PD Module and Medical Record Module; 2clinical data management software;
- Panorama Patient Monitoring Network; Cardiac Arrhythmia Monitor.
2
erScribe/iSite Integration; Picture Archiving and Communication System;
2
software version 3.3
ging - Gyroscan NT MRI System rev 4.x; 5.x; and 6.x software. System;
2
Nuclear Magnetic Resonance i
one powered patient rotation bed; part #209500; distributed by Kinetic
2
Concepts; Inc.; San Antonio; TX
llura Xper FD 10/10 - Allura Xper FD 10/10 x-ray; angiographic system
2
SOMATOM Sensation CT Systems - SOMATOM Sensation CT Systems
2
tem. - SenoScan Full Field Digital Mammography System--Product Number
2
94001G-3; 105200G
stem; Part number 61000-01. The product is shipped as a procedure
2 kit. It is used with a standard 6F g
Epic - Stryker Epic Critical Care Bed; Model 2030.

2
arious CR readers. Technologist review and audit. Key processing 2
for specialized exams; totally autom
Version 6.6 - Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators
2
ular Drive - Roche Modular Drive (rchmdlri); analytical laboratory data
2 interface.
R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which
2
are connected to BacT/ALERT 3
Allura - Allura X-per FD 10/10 x-ray; and fluoroscopy
2
SOMATOM CT System Sensation 40 and Sensation 64. Computed tomography
2
x-ray system.
ansducer - Convex Array Transducer used with B-K Ultrasound ScannersModel
2
number: 8667
ption for Varian MLC - LANTIS XLINK (Impac MultiAccess Sequencer)
2 on Varian accelerators with the ML
with assay software version 1.0. that is designed to work exclusively
2 with the ETI-Max 3000 automated
vers. 5.08; vers.-usa; vers.-tst and vers.-row ; part number GM11005400;
2
for the GammaMed model 1
ian Exact Couch; a component of the Novalis Shaped Beam Surgery
2 System; a table tilt device - power
ET/CT) - Hitachi Emission Computed Tomography SystemHitachi CX-4
2 CT (including SceptreP3 PET-CT)
ptreP3 PET/CT) - Hitachi CXR-4 CT Computed Tomography X-ray System
2
(including SceptreP3 PET/CT)
usion System 1; 100V -120V; 15 A (circuit breaker); 50/60 Hz (20A 2power source required); Models 801
FP1000 Cell Preparation System - FP1000 Cell Preparation System Part
2
Number 624922
Transcutaneous Monitor for p02 and pC02; Model #TCM4; (Cutaneous
2
Oxygen Monitor)
e repeaters in the perinatal clinical environment. It interfaces with standard
2
fetal and maternal monitor
et Cosmos V15C; picture archiving and communications system. Model
2
number 10018969
ms; Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D
2
Digital Spot Film Device
ance Data Management System; Software Version 2.60; modification
2 for the ABL800 Flex Blood Gas An
sonance Imaging Devices - AIRIS II; Altaire Nuclear Magnetic Resonance
2
Imaging Device Systems
2.3.0 and 4.3.7. The software is used in pathology labs for administrative
2
and clinicial documentation
nc.; Digital Radiography System Model DFP8000D - Toshiba Digital 2
Radiography System Model DFP8000
- CR DX-S; DX-S; Computed radiography system (Digitizer) 2
n of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator
3
worn by a patient at risk fo
ectra - MediSpectra Luma Cervical Imaging SystemModel Number:33-02600
ered defibrillator device with battery backup. The defibrillators are
2 primarily used by healthcare provid
ter Defibrillator; ICD. Atrial and Ventricular Therapies. Guidant Corporation
2
Cardiac Rhythm Managem
dioverter Defibrillator; ICD; Models 1870 and 1871. Guidant VITALITY
2
DR+; Implantable Cardioverter
Newport HT50 - Newport HT50 Ventilator (all Models)
2
2
80-T2ASM2. (a Digital EEG/Sleep Recorder Electroencephalograph that
2
includes a built-in pulse oximete
Source; 180 Watt; for endoscopic use. Catalog/Part #72200510; manufactured
2
for Smith & Nephew End
e Opthalmic Laser System; Model No: LP 4532 - Ellex Medical PTY;2LTD 82 Gilbert Street; Adelaide; S.A
rkstation - Kion Anesthesia WorkstationMaquet Critical Care ABSE-171-95
2
Solna; Sweden
ide; S.A. 5000; AUSTRALIA. (The Integre Duo is a dual-wavelength2surgical photocagulator laser intend
3
Cranial Electrotherapy Stimulator - HealthPax Cranial Electrotherapy
3 Stimulator
upine Universal Hip Distractor System; Ref (Part) #72200632; Manufactured
3
for Smith & Nephew; Inc.;
Paradigm Insulin Infusion Pumps for the following Paradigm models:2 MMT-511; MMT-512; MMT-712; MMT
sion Pumps; Baxter Healthcare Corporation; Medication Delivery Division;
2
Deerfield; IL 60015 U.S.A.; M
offer a wide variety of antitachycardia pacing schemes to terminate2 slower; more stable ventricular tac
2+ Defibrillator Automated External Defibrillator (AED)Catalog Numbers:

2
M3860A/M3861A/M3840A/M3
X; 4-840220XXXX-XX; 4-NPB84O-XX; DL4-NPB84O-XX; DS4-NPB840-XX
2 & 4-070550-SP(Note: the Xs ind
nt of the Bio-Rad D10 Dual Program diagnostic test. This is a specific
2 part of the kit; and only the calibr
- Terumo Perfusion System 8000 Roller Pump; 115V; Model 8000; 2Catalog No. 16402.
ystem 8000 Roller Pump; 1040V; Model 8000; Catalog No. 16411. (Not
2
distributed within the United Sta
dule; for in vitro diagnostics; List Number 3M74-01; Temperature Controller
2
Board Part #78560-109; dis
or; a portable 12V internal battery powered defibrillator; Manufactured
2
by MRL Inc.; a WelchAllyn Com
m (Emission Computed); Siemens Medical Solutions USA; Inc.; Molecular
2
Imaging; 2501 N. Barrington R
2
ntegrated Centrifugal System Control Unit; Catalog Number 801046;
2 Terumo Cardiovascular Systems;
7; 2242088-2; 5141609-2; 5115763; and 5128145;Manufactured by
2 Suinsa C Primavera; 39 Pol. Ind. La
Perfusion System; 1 Roller Pump; 6 inch diameter; Catalog No. 801041;
2
Terumo Cardiovascular System
le System; 110 Volt; Product Number: 56000 (HTA system is a software-controlled
2
hysteroscopic therm
s an electromechanical extracorporeal support device used during2cardiopulmonary bypass procedure
del Number(s): iLab120lNS; iLab2401NS; Distributed by and Manufactured
2
by:Boston Scientific Corpora
Perfusion System; 1 Roller Pump; 4 inch diameter; Catalog No. 801040;
2
Terumo Cardiovascular System
tor; a portable 12V internal battery powered defibrillator; Model AED10;
1
Part Numbers: 970302E;97030
Pressure (CPAP) Flow generator with the following model names and
2 product codes: S8 AUTOSET VANT
Terumo Advanced Perfusion System 1; 6 inch diameter Roller Pump;
2 Model 801041.
umo Advanced Perfusion System 1; 4 inch diameter (small) Roller Pump;
2
Model 801040.
ed Perfusion System 1; Integrated (Sarns) Centrifugal System Control
2 Unit; Catalog number 801046.
Compact CT - STA Compact and STA Compact CT; Haemostasis Analyzer;
2
in vitro diagnostic.
tware (Version 2.1); (Version 2.2); (Version 2.3); (Version 2.4); (Version
2
2.5); and (Version 2.6); Serial N
tem; Model 250-''Handhelds'' preprogrammed with software v6.0; v6.1;
2
v6.1.7; v7.0 and v7.1.3; manuf
s reagent system is composed of one bottle of Digoxin-Alkaline Phosphatase
2
Conjugate; one bottle of A
ERVO-i - Ventilator System SERVO-i V3.1 PC1777Maquet Critical Care
2
ps Medical System - BV Pulsera Mobile C-arms with Remote Control2Option; (Release 2)
al Care - Stryker inTouch Critical Care bed; Model 2130; Stryker Medical;
2
Portage; MI 49002
c x-ray system - GE OEC 9900 Elite Fluoroscopic X-ray System; GE 2Healthcare; Salt Lake City; Utah.
- Angiomat Illumena Injector with Auxiliary Console; Mallinckrodt; 2Inc.; Hazelwood; MO.
Advisor - BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)
2
stem; patient side cart Auxiliary power board (APB) (printed circuit2 board assembly); endoscopic instru
icstore - Sienet MagicStore. Radiological Digital Image Communications
2
System
ument; Part Number: 400172-04; Distributed and Manufactured by2Intuitive Surgical; Inc. 950 Kifer Roa
ogies; Incorporated; Ann Arbor; MI 48103. This device is a cone beam
2 CT scan for sinue; temporal bone
tured by MRL Inc.; A Welch Allyn Company; Buffalo Grove; Illinois; Model
1
AED 20; Catalog Numbers 972
LADAR6000 - LADAR6000 Excimer Laser System
1
Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System;
1
Product 7152A.---NO USA Un
TC) ProTime Microcoagulation System Instrument-Catalogue Number-Protimeint
3
& Protimepro; Protimein
3.5.000A; V3.5.000B; V3.6.0; V3.6.000A; V4.0.0; V4.0.000A; V4.l.0;3V4.l.000A; V4.2.0; V4.3.0; V4.5.0; V
act as a Practice Management software application and is intended
3 for use by facilities that provide se
nalyzers - ABL 800 FLEX series blood gas analyzers containing software
3
version 5.24.
5.20 software (also known as NicoletOne Version 5.2 Software) used
3 with the NicoletOne LTM; Sleep; n
Stimulation System - The Precision Implantable Pulse Generator; Model

3
Number SC-1110
IP system ambulatory infusion pumps; (Both) Model 6101; Order #21-8861-01
3
(PCS II) and 21-8821-01
used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner;
3 for nuclear medicine imaging.
th PharmGuard Medication safety Software versions 4.1.3 and 4.1.4.
2 Medex; 4350 Green Parkway; Sui
illator (AED). The devices are designed for non-professional users2and are primarily used in public acc
cT/ALERT - BacT/ALERT Classic System Software; Blood Culturing System
2
or permanent atrial and ventricular pacing. T-Series software VSF07/VSF08
2
Version 1.2. Vitatron is a di
n 4.1. ; GE Medical Systems Information Technologies; Inc.; 8200 W.2Tower Ave. Milwaukee; Wisconsin U
ty sensing using an accelerometer) for permanent atrial and ventricular
2
pacing. C-series software is VS
ntrolled medical device for diagnostic use.; and CELL DYN Control Assay
2
Disk; LIst Numbers 01H91-01
c (CCO/SvO2/CEDV) Monitor Model: VIG2/VIG2E Software Versions:200.51;00.60; 00.61; 00.62; 00.63; 0
mini TFs; GXLs and EBW Workstations. Philips Medical Systems; Cleveland;
2
OH 44143. (The product is
0 through V 2.2.5 and all EBW workstations using software versions2 2.0 through V3.5.2. Philips Medica
Advance Vessel Analysis (AVA) and Advantage Worksation 4.4 with2Volume Viewer 2 (version 6.8 or bef
Analyzer; Part Number 6605632; Beckman Coulter; Brea; CA. (Beckman
2
Coulter; Brea; CA. (Hematology
iagnostics; List Number 3M74-01; v2.10; v2.11; v2.12; v2.20; v2.20DB;
2
v2.30; v2.60 and v3.00; distrib
List Number 106-01; Affected software: v2.10; v2.11; v2.12; v2.20;2v2.20DB; v2.30; v2.60; v3.00 and v
er LH700 Series Hematology Analyzers; Part Number 6605632 with22B Software (2B3; 2B4 and 2B5)
Terumo Advanced Perfusion System 1; 6 inch diameter Roller Pump;
2 Model 801041.
n System - Terumo Advanced Perfusion System 1; 6 inch diameter2Roller Pump; Model 801041.
e Model 8870 Version MMB_01/NNB_01 with N'Vision Clinician Programmer
2
Model 8840 or InterStim iCo
Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision
2
with a Clinic an Programmer M
Software Version 6.5 2021423-015 Revision D GE Medical Systems;
2 Information Technologies; Inc.; 82
ird Gold - Viasys V.I.P. Bird Gold pediatric ventilator; Catalog Number
2 15653
omputer) running the Solaris operating system and software; and 2
a UNIX terminal emulation package
eter input module - Ultraview SL Command Module with Masimo Sp02
2 Option; a multiparameter patien
Q module - ABL800 FLEX Series analyzer with FLEXQ module-equipped
2
with software version 5.2 to 5.2
ound System (System; imaging; pulsed doppler; ultrasonic and system;
2
imaging; pulsed echo; ultrason
ightSpeed VCT System is intended for head and whole body X-ray 2Computed Tomography applications
h BacT/VIEW Software - BacT/VIEW Software; all versions. in vitro
2 diagnostic database software.
stem Software Version 2.2.1; only when using VITROS Chemistry Products
2
THC (Cannabinoids) or AMPH
Lung Ventilator - VIASYS VELA Ventilator; Catalog Number-16186;2Viasys Respiratory Care; Inc.
ered defibrillator device with battery backup. The defibrillators are2primarily used by healthcare provid
mo Advanced Perfusion System 1; Air Bubble Detection Module; Catalog
2
number 802110.
system (Medical Digital Linear Accelerator);MODEL NUMBER: 1940035;
2
MANUFACTURED BY: Siemens M
rumo Advanced Perfusion System 1; Central Control Monitor; Catalog
2 number 802100.
HD11 - HD11XE Diagnostic Ultrasound System
2
Analyzer - Bayer Advia 70 Hematology Analyzer; manufactured by Drew
2
Scientific; Inc.; Dallas; TX.
th Software version 6.2.0 and 6.2.1 and DICOM stations with these2software versions; GE Healthcare 99
; 4.9.1; 4.9.2; 4.9.3; 5.0; 5.0.1; 5.0.2 or 5.0.3 and any Mx8000; Mx8001DT;
2
or Brilliance 6; 10; 16; 16
2
ra Xper FD20 X-Ray System; Release 2.2; Philips Medical Systems;2Bothell; WA 98021
identification numbers 1505-9000-000 and M1057699 (upgrade). 2Datex-Ohmeda; Inc.; a General Elec
ument Control System (da Vinci Surgical System) Model IS1200; A4.3
2 SW level; Manufactured by Intuiti
rt #629637 Software Kit; CXP version 2.0 New User; Part #6296362Software Kit; CXP version 2.0 Upgra
- Pyxis Anesthesia System 3500; Cardinal Health; Clinical Technologies
2
and Services; San Diego; CA
oshiba Aplio 80 Digital Ultrasound System; SSA-770A with version 2
6 software
trait PSR3 System; an electro-surgical device used in dermatological
2 applications
Wheelchair - Invacare Storm TDX Power Wheelchair; Models: #TDX3-PS;
2
TDX3-SE-PS; TDX4-PS.
-240V; 7A (circuit breaker); 50/60 Hz (10A power source required) base;
2
Model 801764. (Not distributed
y computed tomography X-Ray system. The malfunctioning software
2
application is the Tumor Localiz
GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System
2 (Versatile cardiac and vascular).
ity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare
2
Integrated IT Solutions; Ba
Medical Device firmware incorporated with the RadioCamera Extracranial
2
System; distributed by Varia
/CT Scanner; Manufactured by Siemens Medical Solutions USA; Inc.;
2 810 Innovation Drive; Knoxville; T
O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer; 2
Model Number 914863
OC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy
2
treatment.
- Isoloc software Versions 6.5 and 4.5; Part Number NT-NW-425-520.
2 Software for image guided radiatio
ET/CT Scanner; Manufactured by Siemens Medical Solutions USA; Inc.;
2
810 Innovation Drive; Knoxville;
0 Plus system with cranial application (aid to the surgeon for locating
2 anatomical structures in the hum
Management System software for in vitro diagnostic testingProduct
2 # 030102-03
4.2 Software Part Number NT-NW-425-520. Image guided radiation2treatment software.
zation software for determining treatment machine position (to position
2
patients) for high accuracy rad
rsions 6.0 and 4.2. Part Number NT-NW-425-520. Image guided radiotherapy
2
treatment software.
ware Version 4.2; Part Number NT-NW-425-520. Image guided radiation
2
treatment software.
em - LINAC Scapel Treatment Planning System; incorporating FastPlan
2 software versions 4.0; 5.0; 5.0.1
rsion 6.0; Part Number NT-NW-425-520. Localization software for radiotherapy
2
treatment system.
Software for the: Intellivue Information Center; Philips Information 2Center; Central StationModels: M31
nk Informatics System; software version 3.0; Part Number 1000034941;
2
DADE BEHRING INC.; Newark;
- Siemens syngo Dynamics 5.0 Workplace. Medical image report and
2 archive system.
GE Healthcare Innova 4100/4100 IQ. Digital Fluoroscopic Imaging2System (Vascular Angiography Syst
T Spinal Applications used with Regular and Super 9800 and 9600 Arm
2
Systems. GE Health Medical Sy
Intellivue Patient Link; Catalog Number: 865007 and 865015; Running
2
Software Versions J.00.23; J.00
D Ultrasound Version 3.0 with Software Version 3.0 and Biometry 2
A-scan modality; Ellex Innovative Im
kage used with general purpose computer hardware to acquire; store;
2 distribute; process; and display i
which is part of a larger system that includes an nCPAP generator;2 fixation device and patient interfac
- Nemio XG; ultrasound system; SSA-590A with version 1.5 software;
2 Toshiba American Medical System
anced Perfusion System 1 Integrated Centrifugal System Control Unit;
2
Catalog number 801046.
Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance
2
System
y; Multiplan Treatment Planning Software; Versions 2.0; 2.0.1 .6; 1.6.1;
2
1.6..1 or 1.6.3.; Accuray; Sunny
m; Infinix i; Model DFP-8000D; equiped with Digital Radiography System
2
with Software version 3.4er0
- GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system; GE
2 Healthcare; Salt Lake City; UT.
del #4535 670 78851. Brilliance CT 16 Power; Model #4535 670 23331.
2
Brilliance CT 40 Slice; Model
ore Configuration. - Brilliance CT System; Big Bore Configuration; Model
2
#728243. (version 2.2.1)
mography) System with a Pinhole Collimator; Siemens Medical Solutions
2
USA; Inc.; Molecular Imaging; 2
on Digital Imaging (Ximavision); V 7.5.51 with Service Pack (SP); Oncology
2
Information System; Varian M
nd Computed Tomography) System with a Pinhole Collimator; Siemens

2
Medical Solutions USA; Inc.; Mo
2.1 Pharmacy Software-Aspyra - Aspyra; Inc. CyberMED Version 2.1
2 Pharmacy Software
d Auto Launch Report - Cerner Millennium RadNet Auto Launch Study
2 and Auto Launch Report software
aging System; Product Catalog Number: B1-700-00027; Medtronic Navigation;
2
Inc.; Littleton; MA 01460
ns 3.0; 3.0.1 and 3.0.2) and BrainSCAN (version 5.31) Radiotherapy
2 Treatment Planning Software; ; Bra
RATOR APS System Input/Output Module (IOM); List Number: 7L01-01;
2 Abbott Laboratories; Abbott Park
Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand
1
-Model DDU-100A (version 2.0
ic Infusion Pumps; Baxter Healthcare Corporation; Medication Delivery
1
Division; Deerfield; IL 60015 U.S
S v1.07; Model No. 8300-0073; Pharmacy Compounding System; Baxa
1
Corporation; Englewood; CO 80
ysio-Control Lifepak 20 defibrillator/monitor is intended for the termination
2
of certain fatal arrhythmias.
uld benefit from a suction device particularly as the device may promote
2
wound healing; including pati
ngiography; diagnostic and interventional procedures; and optionally;
2
rotational imaging procedures.
rophotometer - UBiT-IR300 Infrared Spectrophotometer; Software2Versions 7.0; 7.01 and 7.11.
procedure table with adjustments (via a remote control) for height;2tilt; back and seat cushion position;
ring System;Horizon Cardiology Hemo External Control Unit;~100 -2230 VAC50-50 Hz; Medcon Telemed
ry Caps used with Animas IR1250 Insulin Pump.The pump is used to
1 help maintain blood glucose targe
s Gamma Camera; Scintillation (gamma) camera; Philips Medical System;
3
Cleveland; OH 44143
m - Invictus-- Bionime Rightest Blood Glucose Monitoring SystemMODEL:
3
GM300; Invictus Scientific; Inc
nic Doppler Flow Detector; Model 811-B (finished assembly without3accompanying probes); Parks Medi
oxygen generator; Reorder Number: HCS02; Packaged in 1 unit per
2 case; Product is an oxygen genera
e: The dual heated adult respiratory ventilator circuits are intended
2 as conduits of breathing gas for ve
ic board of Alaris Pump modules (aka. Medley Pump modules); Model
2 8100 built on or before Septembe
m modules built on or before October 4; 2005:(1) Alaris Syringe module
2
(Model 8110) (a.k.a. Medley Sy
entilator in a compact and lightweight design. It can operate from 2
an internal battery; external battery
only; Medtronic; Inc.; Minneapolis; MN 55432-5604 USA (The Medtronic
2
Activa System in an implantab
07-7550 Datex-Ohmeda AisysIntended to provide general inhalation
2 anesthesia and ventilatory suppor
nc. For continuous patient monitoring of blood oxygen levels; pulse
2 rate and pulse strength measurem
300-AM; Actiwatch 64 Part Number 198-0301-00; Actiwatch 64 AM2Part Number 198-0301-AM; Mini Mit
MRx with a native 256Mbyte internal memorycard with date code "0308.
2
The product is used for the te
Healthcare Corporation; Medication Delivery Division; Deerfield; IL260015 U.S.A.Indicated for infusion v
g; QC; Canada J1X 5Y5The equipment is intended to be used in hospitals;
2
nursing homes; or other heal
2
NIBP Monitor with SpO2 Built-In Printer - BCI Non Invasive Blood Pressure
2
MonitorProduct/Catalog num
nd Imaging System; Models 120INS and 240INS; manufactured by 2Boston Scientific Corporation; Fremo
external defibrillator with battery backup. Part Numbers: 3202487-073;
2
3202487-079; 3202488-036; Ph
vo Multi-modality system - NicoletOne photic adapter cable 085-463700
2
ope CS 100 Intra-Aortic Balloon Pump and DatascopeCS 300 Intra-Aortic
2
Balloon Pump; Datascope Corp
OM Emotion 6 - SOMATOM Emotion 6. Computed tomography X-ray
2 system
mperature sterilizers that use hydrogen peroxide gas plasma to inactivate
2
microorganisms on a broad r
Sensor; Model Number: E403-02; Product Code: PS2225. To monitor
2 oxygen saturation level of patients
SYS AVEA Ventilator; Catalog numbers: 17312-00 (USA Standard with
2 Compressor Version)
ed to be an intraoperative image guided localization system to enable
2
minimally invasive surgery. Ind
ger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger
2
Medical; Inc.; Telford; PA 189
n-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802;
2
Puritan-Bennett Corporation; A
pter; Automated external defibrillator; Used with QUIK-COMBO System;
3
Cardiac Science Corp; Bothell;
mp Module);(3) Alaris Syringe Module (Model 8110) (a.k.a. Medley2 Syringe Module);(4) Alaris PCA Mo
31-00. Device is packaged in clear plastic bags with an attached insert
2
card Insert card reads "TruLin
CA. The HM II LVAS is intended to provide hemodynamic support in2 patients with end-stage; refractory
ad Laurel; MD 20723 U.S.A. www.gehealthcare.com*** Infant radiant
2 warmers provide infrared heat in
63. For use for up to 6 hours in the extracorporeal circulation of blood
2 for arterial perfusion; regional pe
ofrequency signal transmitter and receiver of electrocardiograph physiological
2
signals which are display
thcare P.O. Box 7550; Madison; WI 53707-7550; USA Intended to provide
2
mechanical ventilation for adu
5412; 08255413; 08267697; 08269627; 10038241; 10038242; 10040724;
2
10040725; 10041008;Produ
6" (6.4 mm x 1.6 mm); Black; for use on Terumo perfusion systems2 1; 8000 and 9000; Catalog No: 578
ber 2024489-002.Intended for monitoring fetal and maternal vital signs:
2
fetal heart rate; optional fetal
004 and March 2007 (Axiomtek Panel PC Model Number: 2147-671)
3 VIASYS NeuroCare Part Numbers:
ntrol and monitor external and implantable devices. The minimum3 amount of control involves the abil
antable Cardioverter DefibrillatorEPIC VR Tiered-therapy Cardioverter/Defibrillator;
2
Model V-197
Road; St. Paul; MN 55112; USA; Made in UK. Reorder numbers 21-5301-01
2
& 21-5306-01 The product i
ances; physician's offices; aircraft; stadiums and specialty medical2clinics. ECG monitoring is intended
erica Medical Systems (TAMS) Aquilion 32 CT system; computed tomography
2
x-ray system.
63. For use for up to 6 hours in the extracorporeal circulation of blood
2 for arterial perfusion; regional pe
System; models 120INS and 240INS. Its intended use is for ultrasound
2
examination of intravascular pa
buted in the United States. For use for up to 6 hours in the extracorporeal
2
circulation of blood for arter
ether; they provide an option to help make insulin delivery more discreet
2
and flexible. Also; allows the
sia Machine - Draeger Medical Apollo Anesthesia Machine; catalog 2number 8606500
ERENCE Therapist R2.1 and Primeview 3 i R 2.1. Part numbers 5863506;
2
7339125; 7341410; 7341428;
y assurance checking; 5) Workload recording; 6) Billing charge capture;
2
7) Standards and controls reco
ort Program Hemoglobin Testing System; Model Number 270-0019 2(250 tests); with -thalassemia ROM
m; Model IS2000 with Isolation Transformer (P/N: 952012) and Vision
2 Cart (Model: VS2000); Distributed
ver; License Key. Catalog # ABC code: EXEGE000. The product is2used to transfer medical imaging da
Agfa Heartlab Cardiovascular Results Management Product: Versions
2 2.03 and 2.04. Heartlab; Inc.; We
dheld programming system using Dell x5 handheld and preprogrammed
3
with software v7.1 and highe
500 MPL Flow Cytometry System with MXP Software; Software Version
3 2.1; Automated differential cell c
he following options installed: 3-Scape Imaging; Factory; PN 05937011
3
or 3-Scape Real Time Imaging;
ersions. The Impax Systems are Picture Archiving and Communications
3
system (PACs). PAC systems a
Software Version 1.0; Part Number: 021-722-01(for OneTouch Select
3 and UltraMini (Download) Blood G
tem); Picture archiving and communications system; Model Numbers:
3
5.30.4; 5.30.5; 5.30.6; 5.30.7; 5
mmography System with Software v. 3.3.1.1; Full field digital; system;
3
x-ray; mammographic; Model N
; Catalog Number 355263; Software Version 603.U; Catalog Model 3Number 359251; ICS 3000 units are
02.07Prescriptive medical device used to automatically collect and3transmit medical information (weigh
Technology comes on one skid within 10 cardboard boxes.A therapeutic
3
product designed for individua
asound Scanner w/Step 5 (V05-7) Software. Imaging device intended
3 to provide the physician with phy
elease 1.0.2 and lower). The device is intended for routine exams;3including specialist areas like traum
Therapy System; Record and Verify System); Linear Accelerator with
2 RTP Exchange v6.2; v6.6; & v8.0;
apist 3rd Party V&R medical charged-particle radiation therapy system;
2
Part No: 7345429. Siemens AG
ftware numbers are: 7358299; 7360857; and 8141835 and applies2only to those parts used with the fo
Modular E Module immunoassay analyzer; Roche Diagnostics; Ind.;
2 IN; GMMI Nos. 04998642001 and 0
1. This is a medical charged particle radiation therapy system; part
2 of the firm's beam limiting device/
ems; Catalog Numbers: 5C4471; 5C4471R; 5C4474; 5C4474R; T5C4441;
2
and T5C4441R; Manufactured
nitor is indicated for the termination of certain potentially fatal arrhythmias;
2
such as ventricular fibrillat
itor is indicated for the termination of certain potentially fatal arrhythmias;
2
such as ventricular fibrillati
able Pulse Generator Kit; Model Number: SC-1110 with firmware version
2
prior to Revision 3.02; Advance
d hardware components. The STERRAD Sterilization System is a low-temperature;
2
general purpose ster
sion 4.1. (CIC Pro v4.1). GE Medical Systems Information Technologies;
2
Inc.; Milwaukee; Wisconsin (Sy
r with 12 Lead ECG; Automated external defibrillator; Software Version
2
3.00 and higher; Zoll Medical C
TELECT INTELECT XT; Model No. 2760; Chattanooga Group; Hixson;2 TN 37343; Made in the USA
tem; Distributed by Philips Ultrasound; 22100 Bothell-Everett Highway;
2
Bothell; WA 98021.Pulse Dopp
d on the following power wheelchairs: Q6000; Q6000XL; Q6000Z; R4000;
2
Q600; Q600XL; Q610; Q1107
Technologies Clinical Information Center (CIC) Pro v5.0.3 & v5.0.6 systems;
2
GE Healthcare; Clinical Syst
d System; Software versions 1.0.0 to 1.5.0b. The product is a general
2 purpose; mobile software contro
d by Abbott Laboratories; Irving; TX.The Abbott ARCHITECT cSystem
2 is designed to perform automated
Monitoring Devices; Versions L-NET03; L-NETC03; L-NET05 and L-NETC05;
2
GE Healthcare; Wauwatosa; W
GYN; pelvic and infertility monitoring/follicle development); Pediatric;
2
Small Organ (breast; testes; thy
tem is a diagnostic instrument intended for the automated measurement;
2
analysis and recording of ref
terial number 784539; 7848521; and 7848547.Is a general purpose;
2 mobile; software-controlled; diagn
tometry Software Versions 2.1; 2.1.1; and 2.2 with OS X operating 2
systems; BD Biosciences; San Jose; C
ow Cytometry Acquisition & Analysis software. Catalog number 641609Flexible
2
data acquistion and an
FILS (Patient File Server) software; automatic patient data management
2
providing clinical information a
ternationally only; is indicated for the termination of certain potentially
2
fatal arrhythmias; such as vent
AX 6.2; Picture Archiving and Communications systems (PACs); used
2 in the acceptance; transfer; disp
s Eclipse device; model H48; Version 6.5 is used to plan photon and
2 electron radiation therapy treatme
tor; Material Number: 019490035; with control console software versions
2
6.5/7.2; 8.0; 9.0 and 9.1; Man
0-1028 in polyfoil pouch. Piccolo Comprehensive Metabolic Panel is2 a single-use self-contained reagent
PACs) with integrated Voxar 3D software; and Impax 5.0 and Impax25.2 PACs with integrated MediCAD
-3MS; 740-3NL; 740M-3NL; 740-3NN; and 740M-3NNCAS Medical Systems;
2
Inc.; Branford; Connecticut
Digital Capture System Ultra (SDC Ultra); Model Number 240-050-988;
2
Stryker Endoscopy; image and
n; SC.The Envision E700 Low Airloss Therapy Surface helps prevent2 and treat stage III and stage IV pre
celabls Medical; Ultraview Multigas Analyzer; Model 91518;Spacelabs
2 Healthcare; Issaquah; WA; 98027
his system is indicated for use as a diagnostic imaging device to produce
2
axial sagittula; coronal and ob
OEC 9900 - GE Healthcare OEC 9900 mobile fluoroscopic x-ray system
2
2
s tool for diagnostic images by trained healthcare professionals. It2 is also intended for use as a clinica
ensity; comparison of measured variables obtained from a given scan
2
to a database of reference value
ftware Version 2.1 and 2.2 - FC 500 with UPS; Automated differential
2 cell counter; Part Number: 62655
sion software; automatic patient data management providing clinical
2 information at the bedside in Lab
efinium 8000 - GE Healthcare Definium 8000 Digital Radiographic System.
2
atories2) Track tubes and containers from order to final disposition3)
2 Monitor key metrics such as turna
); 5.0 Systems with software version 200.0.054; P/N : 10032747 and
2 10032746 standard; 10032746; 1
services. The EasyVision RAD provides the following features: receives

2
images sent to it by remote ap
ealthcare; Waukesha; WI 53188 ( The system consists of an a monoplane
2
positioner; a vascular or car
orma Telepack 608;Software Versions 8.1.X; 8.3; 8.3.1; 8.4.1; and 8.5.X;
2
Part Number: 0998-00-0191-0
17 and 4.1. Used in pathology laboratory for receiving accessing specimen
2
reports; billing and manag
AMO); VISX WaveScan WaveFront System (software). Part Number 0070-1478.
2
Advanced Medical Optics
V ASIM S systems;Part Number: 5488460; Product is manufactured2and distributed by Siemens Medica
audiometric test battery. It can be used to assess cochlear function;2 enable estimation of behavioral he
tex-Ohmeda network or Unity Network and Web Viewer clients.Web
2 Viewer can be used for viewing or
ory to Medical Linear Accelerator. The On-Board Imager Device is used
2
for verification of correct patien
al procedures; and optionally; rotational imaging procedures. They2are also indicated for generating flu
Diagnostic Ultrasound System; general purpose Diagnostic Ultrasound
2
system. Siemens Medical Solut
Diagnostic Ultrasound System; general purpose Diagnostic Ultrasound
2
system; Model Number: 824788
patient room kits. The product is used for extended monitoring of 2
EEG in a hospital setting. The syste
ilips PageWriter Touch Cardiograph;Model: 860284; Philips Medical2Systems; Andover; MA; 01810
X-Ray System - Coroskop X-Ray System; Model numbers 6258219 and
2 6379759.
device is designed to assist the operator in providing accurate treatment
2
setups for each patient by m
m intended to display; process; read; report; communicate; distribute;
2 store and archive digital radiolog
opyright 1997-2004 NMPE Build #10302006 CIVCO MEDICAL SOLUTIONSIs
2
an EPID-based (electronic po
e package designed for use in diagnostic imaging. It is a stand alone
2 software package which operates
usion Catheter System which is comprised of a Drug Delivery Catheter
2
(CD) and removable Ultrasound
Medical Vigilance System);Model Number: 010135-01; Product distributed
2
by Hoana Medical; Inc.; 828
ice to produce axial sagittal; coronal and oblique images; spectroscopic
2
images; and/or spectra; dynam
on the Centricity RA 1000 or RA600/CA1000 Workstation; for diagnostic
2
image analysis; GE Healthcare
AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress Pro or2Plus Module; for diagnostic image a
eases 1.2; 2.1; 2.2; and 2.3. - Product is SoftPath ASCII Software Releases
2
1.2; 2.1; 2.2; and 2.3.
ge used with general purpose computing hardware to acquire; store;
2 distribute; process and display ima
re Archiving and Communications System; Radiology software package;
2
Philips Healthcare Informatics;
5 and 5.5.1; model number HZ3; manufactured by Varian Medical Systems;
2
Palo Alto; CA The product
2
728854; Manufactured by Siemens Medical Solutions USA; Inc.; 810
2 Innovation Drive; Knoxville; TN 3
ems; software revisions Sonovista X300 software revision 1.0.06 and
2 1.0.07; Acuson X300 sofware revi
11588 equipped with a Digital Electron Variable Applicator (DEVA; 2Part Number 8485971) with availabl
ser Systems; which are indicated for wavefront-guided laser assisted
2 in situ keratomileusis (LASIK) eye
Model Number: IS2000; A5.1 P1 and A5.0 P5 software level; Surgical
2 Endoscopic Instrument Control Sy
d Communications system (PAC); used in the acceptance; transfer;2 display; storage and digital process
e product is used as a diagnostic imaging device to produce axial 2
sagittal; coronal and oblique images
ith bolus chasing - GE Healthcare Innova 3100 Digital Fluoroscopic2Imaging System with Bolus Chasing
e in data collection; storage; and management with independent bedside
2
devices; and other systems
MM WP). Software product(Model Number 10140720). The product2is intended for use in picture archivi
efinium 8000 Digital Radiographic System. Formerly GE Healthcare
2 Revolution XR/d with Tomosynthes
systems for fixed or mobile installations that combine Positron Emission
2
Tomography (PET) and X-ray C
System; Model number IS2000 Endoscopic Instrument Control System;
2
manufactured by Intuitive Surg
Robotic Radiosurgery System radiation therapy device with Multiplan
2 treatment Planning Software vers
ealthcare Innova 3100 Digital Fluoroscopic Imaging (Cardiovascular

2 Imaging System)
299-2; with console computer and touch screen fullly integrated. the
2 GE Precision 500D Classical Radio
ion 500D Classical R&F System with control room PC; Image-intensified
2
fluoroscopic x-ray system; ; Mo
r BioPlex 2200 Instrument; an automated immunodiagnostic analyzer;
2 Bio-Rad Laboratories; Inc.; Hercu
clipse Treatment Planning System; Client 8.1.18 and DCF 8.1.17; model
2
number H48
(4B5) primary antibody with software version 2.3.0.2; Model Number:
2 VIAS-799-10000-00; Pathology Im
d Version 2.0; list 01P61-01 and 01P61-02. The device is intended 2to duplicate manual analytical proce
he HP XW4400 Computer SystemModel/Catalog number 642685Software
2
is used to simplify acquisition
a X300 ultrasound systems; software revisions 2.0.1 to 2.0.05; 3.0.01
2 and 3.0.02; manufactured by Si
und System; Model: SSA-790A with version 1.1 software; Toshiba America
2
Medical Systems; Inc.; Tustin
nd scanner with software versions 4.0.5; 4.1.1 and 4.1.2. GE Healthcare
2
P.O. Box 414; Milwaukee; Wis
Management System (RPM); A Respiratory Gating System; Version21.7.3; All Models; Varian Medical Sy
aging with versions VB20B; VB20D; VB20F; VB20G; VB25B; VB30A;2VB30A_SP1; and VB30A_SP2.
oherence Therapist R2.0 or R2.1; and PRIMEVIEW 3iR2.0 or R2.1; part
2 number 8139839Medical charge
dentified as Build 1.1.2.11d; B.02.07. Prescriptive medical device used
2
to automatically collect and tra
d Transport Ventilator Continuous Respirator with software version 1.10
2
pre-installed; Catalog number 2
and Communication System; Model Number: 7129534; Software Version:
2
VB30B; Siemens Medical Solu
ore Version 2.04.40.00 software;
Heartlab; Inc.; Westerly; Rhode
2
Island 02891. The software is u
th Digital Spot Imaging (DSI) - General X-Ray System types with Digital
2
Spot Imaging (DSI) software
ens Machines; Model number 40003-001000-RO; Manufactured by 2IMPAC Medical Systems; Sunnyvale;
- Radiation Therapy System. The device is intended to be used as
2 an integrated system for the plann
ment system (software package) used with general purpose computing
2
hardware to acquire; store; dis
2383168; 2383168-2; 2383168-3; 2383168-3-1; 2383168-4-1. The
2 expected use of the Senographe D
Software Suite - HD Module; clinical data management software; Baxter
2
Healthcare Corporation; McGa
System is a diagnostic imaging device intended for radiographic; fluoroscopic;
2
angiographic; and inter
Abbott; ACCELERATOR Device Manager (ADM); List Number: 08H74-01;
2
Abbott Laboratories; Abbott Pa
re application version 2.0 in use with Precedence SPECT/CT System
2 and all CT EBW workstations using
0; 6551345; 6552319; 6552335. The units are labeled under the following
2
firms: EASTMAN KODAK COM
N 55343. ( A web-based medical diagnostic tool that allows physicians
2
to use PCs or notebook comput
mens Medical Solutions; syngo Dynamics 6.0 Workplace; Picture archiving
2
and communication system
Designed to assist the operator of a radiation therapy device in providing
2
accurate treatment setups fo
Archiving and Communication System; software version 2.0; Siemens
2
Medical Solutions; Inc.; Mountain
phy - Acuity with Conebeam Computed Tomography; Radiation therapy
2
simulation system; Model Num
st RTT4.1. Medical Linear accelerator for radiation therapy. The device
2
utilizes a console system for sel
r is a whole body x-ray computed tomography scanner which features
2 a continuously rotating tube-det
.; 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers
2
Software
TELECT VET; Model No. 2843; Chattanooga Group; Hixson; TN 37343;
2 Made in the USA
Model IS2000; Part Number 420215-02; Product is manufactured and
2 distributed by Intuitive Surgical; In
chemistry analyzer; Catalog number 04998618001.Intended for qualitative
2
and quantitative in vitro d
red and distributed by Boston Scientific Corporation; Fremont; CA 2The iReview" Software is provided o
ystem with VB30A version of software. Model Number: 10014063; 2
Siemans Medical Solutions; Malvern
Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361;
2
Philips Medical Systems; Bothell
sion VB31D with 30x40 cm2 flat detectors.AXIOM Artis is a angiography
2
system developed for single a
le Preparation - Vidiera NsP Nucleic Sample Preparation; Part Number:

2
A22421; Version 1.0.41
Management Nuclear Reporting Module; Outbound Report; Model/Catalog
2
No.: L7W1P; Software Version
Installation CD; version 3.1.8. The software is included in a number
2 of Baxter's pharmacy compounde
ory System Software; for recording; reporting and distribution of lab
2 results. GE Healthcare Integrated I
ACS (Picture Archiving and Communications Systems) version 3.6.28.0
2
- Radiology Image managemen
llimator; Medical charged-particle radiation therapy system; Software
2 Version 7.0; Product Code: H56;
ety Software - electronic pump protocol programming software - AdministratorREF
2
21-6275-51 RX only;
nical Chemistry analyzer; Catalog Number: 04745914001; Roche Diagnostics
2
Corporation; Indianapolis;
atic patient data management providing clinical information at the2 bedside in Labor & Delivery; Mothe
nix CentriMag Primary System;Article Number: 201-30100; extracorporeal
1
blood circulation system.
to treat victims of sudden cardiac arrest... Product is capable of 301 full discharges. Labeling on the dev
taport; list #s 02507-04-11; 02507-04-51; AC cord manufactured by
2 Electri-Cord; Westfield PA; Infusion
tput Computer; List # 41245-04-03; AC cord manufactured by Electri-Cord;
2
Westfield PA; Infusion pump
apy device. The Power Supply is plugged into a standard electrical2wall socket and provides low voltag
Med II Model 8637 pumps with batteries (MECC Lifetest Batteries) manufactured
2
from April 9; 2002 thr
nologies Inc. Eclipse Oxygen System; Model 1000Indicated for the 2administration of supplemental oxyg
m enteral pump is a medical device that is used to deliver enteral nutrition
2
products to tube-fed patien
i-STAT Portable Clinical Analyzer; rechargeable battery pack.Printing
2 results of clinical chemistry tests
ve a significant risk of developing these problems and who generally
2 also have one or more of the follo
Mechanics - Respironics Esprit Ventilator System; Model Number V1000
2
with Optional External Battery;
sition; processing and archiving capabilities.Innova 2000 The principle
2
system components include a
Zoll AED Plus - Zoll AED Plus Defibrillator
1
153; BRM8153T; BRM8153RT; PNM8153; PNM8153T; PNM8153RT; CNM8153;
1
GNM8153; HNM8153; TRM
HemoSense Incorporated.The INRatio2 PT Monitoring System is used
3 for the quantitative measurement
ibular stimulation during caloric testing. The caloric tests evaluate3the viability of the horizontal semic
eries Heated Humidifier System - Remstar Pro M-Series Heated Humidifier
2
System.
04; M1151662;M1152224; M1158990; M1100486; M1122080; M1126444;
2
M1163003; M1163255M113
er box; sterile; Stryker; Kalamazoo; MI; REF 525-125.The Stryker PainPump2
2
is an electromechanical pu
lyn AED 10 automated external defibrillator and MRL Jumpstart (collectively
2
"AED 10")
is intended for general and critical ventilatory care for use on adults;
2 pediatric; infant and neonatal pa
hycardia pacing and ventricular defibrillation for automated treatment
2
of life-threatening ventricular ar
Link is a single use; disposable component of the NeuroStar TMS system;
2
a non-invasive treatment for
umbers: 980100; 91000103; 91000153; 91000154; 91000156 The2device is a medical point-of-care de
86-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.).
2 Intended for warmingpatients befo
Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 4mm Catheters;
2
Part Numbers: D-1257-01 &
ed circuit assembly (PCA) within the monitor.The LifeVest is indicated
2 for adult patients who are at risk
S Model T125 DR. Implantable Cardioverter Defibrillator; Sterile Lot.2 Guidant Corporation; Hamline Aven
nn Arbor; MI; Catalog number 802110.For use for up to 6 hours in the
2 extracorporeal circulation of bloo
Code 10050.Low-temperature general-purpose sterilizer used to sterilize
2
heat and moisture sensitive r
base. Terumo Cardiovascular Systems; Ann Arbor; MI. Model 801763.The
2
device is indicated for use in
RESPIRONICS V60 VENTILATOR - RESPIRONICS V60 VENTILATOR2
CIC Pro" clinical Information Center central station is intended to collect
2
information from a network and
Board;Part Number 450116-0002.Performs chemiluminescent immunoassays
2
using serum; plasma; an
-2061.Indications for use: SPECT + CT: Perform scans and nuclear 2

imaging studies with the same instr
ne Avenue North; St. Paul; MN 66112-5798; USA.The product is indicated
2
for patients who are at risk fo
X-ray System - Definium 5000 X-ray System; model number 5220493
2 and 5220393-2
(server and work station); Xoran Technologies; Ann Arbor; MI. Cone
2 beam CT for sinus; temporal bone
burrs; trephines; and their accessories. Catalog Numbers: EMAX2-FP
2 and FPLUS-FP.Indicated to cut an
achycardia pacing and ventricular defibrillation for automated treatment
2
of life-threatening ventricular
between April 2008 and January 2009).The Alaris PC Unit is the central
1
programming and power supply
fibrillator deployed primarily in public access defibrillator environments
1
where the expected use for an
pump - Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001;
2
4759702001 and 47597290
Advance - GE Datex-Ohmeda Advance Anesthesia Gas-Machine.2
patient care needs.The Medfusion 3500 Syringe infusion pump is designed
2
for the administration of flu
St.Jude Medical; Sunnyvale; CADisposable connecting cable; accessory
2
to the Epicor Cardiac Ablation C
les physicians to periodically monitor both patient and device status
2 remotely. The LATITUDE Patient
xygen Sensor #5804; Distributed by: Teleflex Medical; Research Triangle
2
Park; NC 27709
bott Laboratories; Diagnostic Division; Abbott Park; IL 60064 USA; Product
3
List Number: 6E58 (US) and
Phoenix Infusion System with MedNet Software; Symbiq One-Channel
2 Infusion System; Software versio
G; NBP; Temp; IPB; SPo2 Bedside Patient Monitor with 10" display 2Part number: VM3:863077;4535640
lation. The device is for use by qualified medical personnel trained2 in the operation of the device and
at an hourly flow rate and provides the option for patient controlled2 bolus doses. Medications and narco
of the Trilogy Radiotherapy Delivery System for radiation therapy intended
2
to delivery megavoltage xentricular fibrillation. The device is for use by qualified medical personnel
2
trained in the operation of th
T/CT consoles.Image analysis software package that allows the user
2 to produce image data and to gen
cedures for detection of radioisotope tracer uptake in the patient body;
2
using a variety of scanning mo
apnograph/pulse oximeter monitor and monitor with printer. Part numbers
2
CS 08651; CS 08653; CS086
Manager (4250); Anesthesia Manager (4220); PACU Manager (4245)2& Critical Care Manager (1110); pa
ed medical personnel for the purpose of converting ventricular fibrillation
2
to sinus rhythm or other card
olutions USA; Inc.; Symbia S Series SPECT System; Single-Photon Emission
2
Computed Tomography; Part
natomy without requiring multiple contrast injections and radiation
2 exposures. The product is indicate
diovascular failure. The iPulse console can be used to drive exclusively
2
one of two classes of therapeuti
essories used with MAKO's Tactile Guidance System (TGS). The Tactile
2 Guidance System is intended to
MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build
2 67 and build 122. Manufactured b
eraMapTM Software; for oncology treatment planning; assessment2and monitoring of the patient respo
agnost Eleva Flat Detector System with software version 4.3.1 or higherUsed
2
for general R/F; fluorosco
1
"AED 10")
W012; 1.0 software in EnTrust(R) (D153ATG; D153VRC; D154ATG; D154VRC)
3
and EnTrust(R) Escudo (D14
cs VNS Therapy Demipulse Generator; Model 103; an implantable;3multiprogrammable; vagus nerve s
VNS Therapy Demipulse Duo Generator; Model 104; an implantable;
3 multiprogrammable; vagus nerve
tation ECG Management System - AGFA IMPAX HeartStation ECG Management
3
System.
edefined settings. Actual settings are read from the treatment machine;
2
via the machine's communica
atient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module)
2
Model 8120 used with the Ala
gement System version 2.0.9 - Animas ezManager Max Diabetes Management
2
System version 2.0.9
ozmo Insulin Pumps are ambulatory electromechanical pumps used
2 for delivering insulin to patients w
on. Physiological parameters and waveforms from GE Healthcare Information
2
Technologies monitors an
rt G3 - Cardiac Science Powerheart Automated External Defibrillator

2 G3 9300E.
em; model number 250; version 4.6; 6.1; 7.0 and 7.1. The Model 250
2 Handheld software is provided on
sis and Continuous Renal Replacement Therapy devices are used for
2 acute and chronic hemodialysis; i
alon Fetal Monitor - Philips Avalon Fetal Monitor FM20; Model Number:
2 M2702A.
L Monitors with Omega S Package - Delta/Delta XL Monitors with Omega
2
S Package
heal or tracheostomy [ET] tube) or non-continuous(mask) ventilatory
2 support and monitoring for infan
parameter physiological patient monitoring system intended for use
2 on adult; pediatric and neonatal p
evices in Monitor Network. Network connection consists of hardwire2 network and/or wireless LAN (WLAN
atient's bladder; and a battery operated console that provides measurement
2
related information. The
omparison of measurable variables obtained from a given QDR scan
2 to a database of reference values;
r of a radiation therapy device in providing accurate treatment setups
2
for each patient by monitoring s
(Model 2130) with the Integrated PositionPro mattress (Model 2920)
2 option.The device is intended to b
er InTouch 1.0 Critical Care Bed; Model 2130.The device is intended2 to be used as an Intensive Care Un
ndex Dental Systems; 901 West Oakton Street; Des Plaines; IL 60018.Intended
2
for use of the software is
are Integrated IT Solutions; Barrington; IL 60010.The Centricity PACS
2 is used to receive; store; distribut
software; GE Healthcare Integrated IT Solutions; Barrington; IL 60010.
2 The Centricity PACS is used to re
for diagnostic images by trained healthcare professionals; including
2 radiologists; physicians; technolog
e Central Control Monitor (CCM) provides a centralized display of system
2
information and on-screen co
ned for in vitro diagnostic use in clinical laboratories. The instrument
2 has two modes of operation: the
ted for monitoring of hemodynamic (including arrhythmia and ST-segment
2
analysis); respiratory; ventil
agnostic images by trained healthcare professionals; including radiologists;
2
physicians; technologists;
Nuclear Medicine imaging procedures for detection of radioisotope2tracer uptake in the patient body; u
quick access to medical images and related data they need via a web
2 browser; password and a standa
rt Diagnostic Ultrasound Systems - GE Healthcare Voluson E6; GE Voluson
2
E8; and GE Voluson E8 Expe
00; 799-13000-00R; 799-14000-00 and 7914000-00R.PrepStain is a2 liquid-based thin layer cell prepara
s product is used for the qualitative and quantitative measurement2 of biological and physical propertie
ware - Cytomics FC 500 Flow Cytometry System with CXP Software;2Part Numbers: 626553; Version 2.2
Mobile Fluoroscopy System - GE Healthcare Fluorostar 7900 Mobile 2
Fluoroscopy System
es of human anatomy for vascular angiography diagnostic and interventional
2
procedures and optionall
Medical Systems Eclipse treatment planning system; Model Number
2 H48; versions 6.5/7.x and Inspira
n DR; full field digital mammography system. Model Number 06646900.The
2
device is used for full field
onville; FL 32216-0980 USA.Distributed by: Medtronic Powered Surgical
2
Solutions; 4620 North Beach S
ned healthcare professionals; including radiologists; physicians; technologists;
2
clinicians and nurses. It
ct is indicated for use in generating fluoroscopic images of human 2anatomy for vascular angiography d
mo II DR - Medtronic Maximo II DR D28DRG; for ventricular pacing2and defibrillation.
ended Brilliance Workspace (EBW)" Dental Application v4.0 and v4.0.1
2 is a component of the Computed
number 09H39-01. Distributed by Abbott Diagnostics Division; Santa
2 Clara; CA.Automated analyzer in
go Multimodality Work Place (MMWP) and on the CT workplace; Model
2
number 10094833.Picture Archi
ystem intended to produce cross-sectional images of the body by computer
2
reconstruction of x-ray tra
ms vs. 7.0; 7.0.1; 7.0.2; 7.1; 7.1.1.The MUSE Cardiology Information2System is intended to store; access
-parameter automated hematology analyzer designed for in vitro diagnostic
2
use in clinical laboratories
alyzer that measures pH; blood gases; electrolytes; glucose and oximetry
2
in whole blood. The ABL 80 C
and software version 8.5.5; 8.5.6; 8.6.1 or 8.7.Datascope Patient MonitoringIntended
2
for use in a fixed
g number 04862392001; catalog number 05093236001; and catalog

2 number 05201357001.Automate
an integrated system for the planning and delivery of intensity modulated
2
radiation therapy (IMRT). Th
management for the anesthesiologist at the point of care within the
2 operating room. The system track
vivo imaging and measurement of the retina; retinal nerve fiber layer;
2
macula; and optic disk. The Str
ircular ARC SRS/SRT Planning.The software is intended for use in stereotactic;
2
conformal; computer pla
g of the placement of dental implants and pre-surgical fabrication of
2 stents to aid in dental implant inse
GE Healthcare Integrated IT Solutions; Barrington; IL 60010.The software
2
delivers a scalable and flexible
mography x-ray system which is intended to produce cross-sectional
2 images of the body by computer r
s tool for diagnostic images by trained healthcare professionals. It2 is also intended for use as a clinica
volution XR/d system control room PC model 5117866-2 with Software
2
collector 5115434
ical Information PortfolioSoftware Version D.0; for patient data collection;
2
storage; and management.
evices; and ancillary systems that are connected either directly or through
2
networks. It is indicated for
6.0 when used with LINK; Model numbers H88 and H85. Manufactured
2
by Varian Medical Systems; Palo
herapist Assist; Therapist Express Basic; and Therapist Express Assist
2 Systems; manufactured by Siem
oduct code: E2FB6Agfa's Computed Radiography Systems with NX2 Workstations are intended for use i
with Part Numbers 0250-003-016; 0250-003-017 and 0250-003-018
2 (OrthoPad)Intended use of Guardia
ftware collector 5194381. GE Healthcare; 3000 North Grandview; Waukesha;
2
WI 53188.Intended for us
osoft Navitrack; OS Unicondylar Knee 1.0 - Universal; software application
2
for orthopedic surgical stere
T 6.6 or earlier software for use with Neuro Kinetics products.The device
2
is used for vestibular testing.
onara. Part Number of Units: 982A0470 Sonara Bilateral.The Sonara
2 Transcranial Doppler system is a m
Accuray Inc.; Sunnyvale; CA.Indicated for treatment for planning and
2 image-guided stereotactic radios
0240-030-004 and/or 0240-030-002; 0240-030-008 (Net Practice).The
2 intended us of Guardian is to act
Imaging; picture archiving and communications system (PACS); Model
2
number 10 014 063
Medtronic O-Arm Intraoperative Imaging System Catalog Number:2BI-700-00027
dependent bedside devices; and ancillary systems that are connected
2
either directly or through netwo
Assist system (Part Number 8162807); with Software version NET 2
VA10A for RTT4.1.122 or RTT 4.1.125
X-Ray System - Hitachi CXR4 Computed Tomography (CT) Scanners;
2 Software Version 1.51 or less.
X-ray System intended to produce cross-section images of the body2 by computer reconstruction of x-ra
dy at different angles. The system reconstructs; processes; displays;
2 and stores the collected images.
Carina Home Ventilator.The device is used as a continuous respirator/ventilator
2
for home use.
em intended to be used by trained professionals; and is a software2package used with general purpose
d 67 and automatic Motion of Flat Panel; part number 8139789; manufactured
2
by Siemens Medical So
ng XS - Syngo Imaging XS VA60 and VA70 in combination with JPEG
2 Compression
uct is a laboratory information system. It is designed to facilitate the
2 general clinical; anatomic pathol
agnostic images by trained healthcare professionals; including radiologists;
2
physicians; technologists;
an NFS connected archive and V30A systems where image data was
2 stored to LTS using software vers
onstruction; and image archive/evaluation. It is intended to produce
2 cross-section images of head and b
cations System - IntelePACS Picture Archiving Communications System
2
InteleViewer module; Model #3
yngo Imaging Version V31 Picture Archiving and Communication System;
2
model number 10014063.
LERATOR APS System Input/Output Module (IOM); List Number: 7L01-01;
2
manufactured by Inpecco SpA
online multi-planar image viewing; offsite data storage; administrative
2
reporting tools; and teleradiolog
ers: 4535 679 83931 - GEMINI TF 16 Slice; 4535 679 94741 - GEMINI
2 TF-64 Slice and 4535 674 41711 n and Analysis Software.Intended for clinical lab use with ELx800 and
2 ELx808 microplate readers; offer
09-430 with Part Numbers 0240-020-013 and 0240-020-022 (Office2PACS Power).Intended use is to act
ptisurgical; Horizon Phacoemulsification System; Model: HZN-2030;2for ophthalmic surgery.
nd Scanners; DICOM Option EZU-FC5; Software Versions: V01-03; V01-05;
2
V02-04; V03-02; V04-02; V0
ked cardiovascular information management system. The IMPAX Centric
2
Polling Procedure provides a
ntage and intensity of positively stained nuclei in formalin-fixed; paraffin-embedded
2
tissue specimens i
an X-ray system and a digital detector)Indicated for use in diagnostic
2 and interventional angiographic p
cimen Collections - Cerner Bridge Medical Transfusion Administration
2 and Specimen Collections; Version
ture Collimator; Software version 3.0.Product is indicated for treatment
2
planning and image guided ste
g XS - Syngo Imaging XS VA60 and VA70 in combination with a NAS
2 or HSM license
Varian Medical Systems; Eclipse Proton Convolution Superposition DCF;
2
version 8.6.15; Model H48; radi
ion 8 and above when used with the Alaris PCA Module (Model 8120).The
1
Alaris PC Unit is the central p
1
"AED 10")
Welch Allyn AED - Welch Allyn AED 10 Automated External Defibrillator
1
on System II- CART; Stryker Navigation; Kalamazoo; MI; Stryker REF1 7700-100-000.Intended to be used
Millennium Microsurgical System - Bausch & Lomb Millennium Microsurgical
2
System.
spironics/Philips product.Used for trending O2 and CO2 tension at the
2 skin surface for neonates and ad
Account Manager) to the physician's specific treatment plan for each
2 patient. The patient is given instru
cal device that monitors; detects; and treats atrial tachyarrhythmia2episodes. It also provides bradycar
e termination of ventricular tachycardia and ventricular fibrillation.2 The device is for use by qualified m
from the Demipulse Generator to the vagus nerve by the lead. The
2 lead and the Pulse Generator make
uchscreen display; 19-inch thin film transistor liquid crystal display 2(TFT-LCD). The PNs are 010-1619-0
er Medical; Inc.; 3135 Quarry Road; Telford; PA 18969inhalation anesthesia
2
machine for use in operatin
he infusion pump; Distributed by: Hospira; Inc.; 275 N. Field Drive; Lake
2
Forest; IL 60045; part number 3
r Vital Signs Monitor uses power cord WW3005 (Electri-Cord Manufacturing
2
Co.; 312 Main St.; Westfield
onic Bio-Console 550 centrifugal pump console; Model #95180; Catalogue
2
#95180; E95180; R95180
edtronic StealthStation S7 System - Medtronic StealthStation S7 System
2
Hybrid/Digital/CR - Mobilett XP Hybrid/Digital/CRIntended use: mobile
2 x-ray system
s - Power supply boards on Dash 3000; 4000 and 5000 Monitors.GE2Healthcare; 8200 West Tower Avenu
Tabs Professional Monitor; includes one wall bracket; Model 25022.
2 Stanley Senior Technologies; Linco
D-Solis Ambulatory Infusion Pump. These power cords allow users2to run the pump via AC power rathe
ammer Model Number SC-7150-4 - Bionic NAVIGATOR Clinician Programmer
2
Model Number SC-7150-4
stic). Philips Respironics; Monroeville; PA 15146.Provides continuous
2 or intermittent ventilatory suppor
tured by Defibtech; LLC. Seymour; CT 06483.The DBP-2800 battery
1 pack is an accessory to the AED a
brillator/monitor.Product Part numbers: 3202487-xxx; 3202488-xxx;
1 U3202487-000; 3202488-015; and
potassium; ionized calcium; hematocrit; pH; PCO2; PO2 and the i-stat
2
portable analyzer as part of the
automated external defibrillator (AED) Model M3860: Philips brand;2 configurable ECG on screen; config
tronic Dual Chamber Temporary Pacemaker; model 5388. Manufacturer:
2
Medtronic; Inc.; 710 Medtron
urnee; IL 60031; Model 758000The device is a portable aspirator to
2 help evacuate saliva; mucous; vom
aryngeal Surface Electrode (Model LSE500DCS and LSE500DCL)For2use as a Surgical stimulator/locator
0-19 - The product is a 19" Spacelabs Medical Flat Panel Display; Model
2
94260-19; manufactured by EL
K 12 DEFIBRILLATOR/MONITOR - Biphasic LIFEPAK 12 defibrillator /2monitor.
icular tachycardia and ventricular fibrillation. The device is for use2by qualified medical personnel train
ms operating with A100 Generator - Axiom Artis Systems operating2with A100 Generator
Heartstart (HS1) Onsite Automated External Defibrillator (AED) Catalog

2
number M5066A
of individuals who require mechanical ventilation. The ventilator is2 suitable for use in institutional; hom
hospital; hospital-type; and intra-hospital transport environments. Hospital
2
use typically includes gener
mbly (also called the Aspiration Bottom Sensor) used on the Cell-Dyn
2 Sapphire Hematology Analyzer; M
l Flouroscopic Imaging System - Innova 2000; manufactured by GE2Medical Systems; SCS
ufflators; model numbers 620-040-600 and 620-040-610; manufactured
2
by Stryker Endoscopy; San Jos
80001.The ViewSonic 19" flat panel LCD display Model VG930M is used
2
as part of the Welch Allyn Acuit
tor - Respironics V60 Ventilator; manufactured by Respironics California
2
Inc. in Carlsbad; CA.
e Defibrillator - Model 4000 Monitor component of the LifeVest Wearable
2
Defibrillator
external speakers can be identified by their use of DB15-to-3.5 mm
2 mini-phone jack cable (Agispec-08
550 TxT Patient Table; Part No. 7346534; Distributed by and/or Manufactured
2
by Siemens AG; Medical
C-arms and it allows the operator to image in two planes: Lateral 2and Frontal. It has a C-arm on the s
er Surgical Table; Catalog numbers 0788100000; 0788100000S; 0788100001;
2
and 0788100001S
cemaker is designed to be used with cardiac pacing lead systems for
2 temporary atrial or ventricular or
or/Monitor; models 2025653; 2026109; and 2026114 that were manufactured
2
between July 25; 2008 a
systems with Motor Controller Unit. Siemens Medical Solutions USA;
2 Inc. Malvern; PA 19355.Intended
ration; San Jose; CA.The Chilli Cooled Ablation System is indicated2for cardiac electrophysiological map
lved with this report are angiographic X-ray systems with a solid state
2
x-ray imaging device for cardiov
n; Burdick; and Cardiac Science). - Treadmill models TM55; TM65; 2
and CR60 (brand names include Qui
mmable diagnostic computer intended for acquiring digitizing; storing;
2 displaying ; and reviewing hemo
9300E; 9300P; 9390A/E; CardioVive: 92532 and 92533; Nihon Kohden:
1
9200G; and 9231; and Respon
E Avance - GE; 1009-9002-000 Avance Anesthesia Machine and Monitor
1
multiple physiological parameters of adults; pediatrics; and neonates
2 in a hospital environment. ST segm
on cable assembly; catalog numbers 78-8067-7375-6 and 149892;
2 Terumo Cardiovascular System; A
d during open heart surgery. Models:M4741A - Extra Large Switched
2 internal PaddlesM4742A - Large S
e found under the X-ray trolley cover on the front lower right side 2
of the module or under the stand co
eedback on the rate; depth and complete release of compressions;2ventilations rate and lack of CPR ac
between December20; 2008 and May 6; 2009; and Alaris PC Units1 (with logic board part number TC10
nitric oxide (NO); as set by the user; to the patient throughout the 1inspired breath. It uses a specially d
d to ScanPoint Communications Cradle) states: "...VERATHON ScanPoint
3
Docking Station...Part No. 0570
e: Assayed materials used with the Triage Profiler S.O.B. Panel; Triage
2
CardioProfilER Panel; Triage BNP
ms to aid in the diagnosis and treatment of myocardial infarction and
2 cardiac muscle damage. Cardiac
tor; Distributed by Boston Scientific; 4100 Hamline Avenue North; St.
2 Paul; MN 55112. Models 6476 (U
103 and VNS Therapy Demipulse Duo Generator; Model 104VNS Therapy
2
Programming System; Mode
exPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro 2Telemetry version 3.9 software)
odel 3500 syringe Infusion pump; software version V3.0.6. Model 3500.
2
Rx Only. Smiths Medical MD;
owerheart.Device Operation: Fully automatic.Color: Yellow.Voice Prompt
2
Level: Extensive.(Extensive vo
nt monitors passively display data generated from Spacelabs Medical
2 patient parameter modules; Flex
acquisition and reconstruction software; associated accessories and
2 connections/interfaces to accesso
CAPE TM Monitor B850 is a multi-parameter high acuity patient monitor
2
intended for use in multiple ar
UCTS 6501 * (number located on the generator cabinet).Intended use
2 for Angiographic X-ray system w
rocessor; Leica Biosystems Melbourne Pty Ltd; Mount Waverly; 3149
2 VIC; Australia; catalog number 26
Chek analyzers; Manufactured by Polymer Technology Systems; Inc.;
2 Indianapolis; IN.Catalog # 1711.In
stems are indicated for use in generating fluoroscopic images of human

2
anatomy for diagnostic and in
curay Inc.; Sunnyvale; CA.Indicated for treatment planning and image-guided
2
stereotactic radiosurgery
eral radiographic examinations and applications wherever a solid state
2
X-ray imaging device can be u
del # DC1490;Marus MaxStar-Agency Model # DC1690;Marus NuStar-Agency
2
Model # DC1700;Marus N
Xario - Xario; SSA-660A; software version 1.0 and later
2
5; R4.0 and R4.2. Elekta; Inc. Norcross; GA 30092.Intended for use2as a radiation therapy treatment of
.1 - 08/13/08; 4.0.2.2 - 06/06/05; 4.0.2.3 - 09/19/05; 4.0.2.4 - 09/19/05;
2
4.0.2.5 - 09/19/05; 4.0.2.7 - 0
o the Sentry DDU-1 00 semiautomatic external defibrillator (AED).The
2 DDC-6-AA data card is an access
rchange - i-STAT HL7 InterfaceThe HL7 Interface product is an accessory
2
to the analyzer
ra Inc. Symbiq One- and Two- Channel Infuser; List Numbers 160261 and 16027 respectively.
nc. Redmond; Washington USA.The LIFEPAK 15 monitor/defibrillator
1 is a complete acute cardiac care r
cal system that is indicated for both anterior segment (i.e. phacoemulsification
1
and removal of catarac
y Abiomed; Inc. Danvers; MA.Intended to provide complete short-term
1 support of the left and/or right s
er; Inc. Brea; CA.Quantitative; automated hematology analyzer and3leukocyte differential cell counter fo
14.Intended for multiple uses as it is an electronic battery-operated3 monitor used in conjunction with a
Diopsys Inc.; Enfant Pediatric VEP Vision Testing System; Input: 120
3 Vac; 60Hz/2.5A IEC 60601-1 Class
al specimens. A complete listing of the organisms addressed by the
3 RapID Yeast Plus System is given in
7.3; - Integrated Data Management System - Version 7.1; 7.2 and 7.3;
3 ITC Corporation; 8 Olsen Place S
version 60.80.101.025 (referred to as Nano 1.0.5).The software is 3used with the SonoSite NanoMaxx u
Beckman Coulter; Inc. Brea; CA.Quantitative; automated hematology
3
analyzer and for in vitro diagnos
Pump - One Touch Ping Insulin Pump using ezManager Max diabetes
3 management software
and TrueBeam STx; Model Number:TMX- H19; Distributed by and Manufactured
2
by: Varian Medical Syste
Product is manufactured and distributed by Bio-Rad Laboratories; Diagnostics
2
Group; Hercules; CA.Prov
adycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia
2
therapies; and atrial tac
flex Medical; Hudson RCI; Concha Therm Neptune; Heated Humidifier.
2 Product numbers: 425-00; 425-1
perating room personnel the ability to capture still images and to record
2
video during the surgical proc
on Card for use in the Medtronic model 8840 Physician Programmer.
2 Manufactured for: Medtronic; Inc.
System - NicoletOne vEEG System; VIASYS Healthcare; Inc.; Madison;
2 Wisconsin 53711.
ARE VERSIONS 2.0.2; 2.0.3; AND 2.0.4 Medfusion Syringe Infusion2Pumps are designed for use in critic
including Co-Oximetry.The Siemens 400 series system is intended2for point of care and laboratory test
/ Transport Pro Monitor - GE Healthcare Transport Pro Monitor with2 the CARESCAPE" Patient Data Mod
ment Planning System; with v client versions 7.3 (build 7.3.10); 8.0
2 (builds 7.5.x); 8.1 (builds 8.1.x) an
st of hardwired network cables and/or Wireless LAN (WLAN) connections.
2
Furthermore; it coordinates th
antage 2.0; Seno Advantage 2.1 - GE Seno Advantage 1.x; Seno Advantage
2
2.0; Seno Advantage 2.1
clipse radiotherapy Treatment Planning System (Eclipse TPS); Eclipse
2 Version 7.3.10 (multiple workstat
ctured by Optovue; Fremont; CAThe RTVue is an optical coherence 2
tomography system indicated for th
gical Tables; Model #'s: Cmax110; Cmax 220 manufactured by Steris
2 Corporation in Montgomery; AL
4 Milwaukee; WI 53201. - Signa Excite" 1.5 T Magnetic Resonance
2 Systems; manufactured by GE Hea
lite - GE OEC 9900 Elite ESP To produce mobile fluoroscopic images
2 of human anatomy.
7.0X. Zoll Medical Corporation; Chelmsford; MA.Intended for the purpose
2
of converting ventricular fib
t and communication during surgery. The SPI2 and SPE route surgical
2 and non-surgical images through
lation and coagulation of soft tissue; as well as hemostasis of blood
2 vessels through its electrosurgical
ratory quotient (RQ)) and neurophysiological (including electroencephalography
2
(EEG); Entropy; Bispec
; for use with radiotherapy treatment machines; Class IIb; manufactured

2
by Impac Medical Systems; Su
ed to receive medical images (including mammograms) and data from
2
various imaging sources. Image
al use in the hemostasis laboratory for coagulation and/or fibrinolysis
2 testing in the assessment of thro
. The MAC 800 is intended to beused by trained operators in a hospital
2
or medical professional's facilit
01.1Product is intended to be an intraoperative image-guided localization
2
system. It is a computer-ass
emodialysis Machines; Baxter Healthcare Corporation; Deerfield; IL2 60015; product codes 5M5538; 5M
at uses digital geometry to generate a three-dimensional image of 2the inside of an object from a large
cal Systems with Dxl System Software versions 4.2 or 4.2.1.In vitro2 diagnostic device used for the qua
ough the esophagus or stomach of the patient into the heart. The TEE
2
transducer is intended to be use
n ultrasound device that projects ultrasound energy either into the 2lower abdomen to obtain an image
is labeled in part: "Philips Easy Diagnost Eleva Conventional R/F system...PHILIPS".
2
manufactured by P
d to project ultrasound energy through the lower abdomen to obtain
2 an image of the bladder and mea
s a mobile X-Ray system designed for medical applications in surgical
2 theaters; focusing on 3D imaging
Treatment Planning System is intended as aid in quickly and precisely
2
planning the radiation treatmen
in Group Paradym sonR CRT-D Model 8770.Made in Italy by Sorin Biomedical
2
CRM S.r.l. Via Crescentino
hilips IntelliVue Clinical Information Portfolio (ICIP); Clinical Management
2
SystemSoftware Version D.00
ed for post processing based on dynamic CT images continuously acquired
2
during the infection of cont
t provides basic trends in both tabular and graphical format; along2with a retrospective ECG analysis. T
3.1.4-3.1.4.27; 3.1.6-3.1.6.4; 4.0.0.0-4.0.0.9; LAB/MIC Add-on 4.0.1;
2 4.0.1.0-4.0.1.13; 4.0.2.0 in 2006.
iew GT Electronic Portal Imaging Device; used with radiation therapy
2 treatments.
art Number 4512 201 04752 Software Version 1.5.1 and Part Number
2 4512 201 04753 Software Version
umber 7-94255-01 and PM LLS kit; U10 Chip and Ejectors; part number
2
7-200788-01.The Abbott ARCHIT
Richmond; Canada V6X 3G5.Intended to receive; transmit; store; retrieve;
2
display; print and process dig
e Calculator - EndoTool Drug Dose Calculator-Software Version 7.2.1800.3
2
and 7.2.1825.5
oftware - Vitrea 5.1. Vitrea fX 3.0; Vitrea Enterprise Suite 1.2 with the
2 licensing of CT lung or CT Colon.
Fluoroscopic Imaging System consists of an a monoplane positioner;
2 a vascular or cardiac table; an X-r
3.17.8 03/03/2004. Version 4.1.0 07/03/2003. Version 4.1.1 10/03/2003.
2
Intended for use in the Patho
Blease Beech House; Chiltern Court Asheridge Road; Chesham; Bucks
2 HP5 2PX; EnglandIntended for u
Software version 3.2; Part Numbers 435-0602.01 to 05; including ChromaFlo
2
and Virtual Histology; man
sound device that projects ultrasound energy into the mid-abdomen
2 to obtain an image of the abdomi
media interchange of multi-modality images from a variety of diagnosis
2
imaging systems. When interp
of treatments in stereotactic radiosurgery and stereotactic radiation
2 therapy. It processes the inputs of
device is for a remote medical data collection device for the monitoring
2
of patients by healthcare provi
Leksell SurgiPlan - Leksell SurgiPlan
2
.4.1 2008-09-30 (Manuf Date). SoftPath GUI version 4.3.0.3; 2008-07-23
2
(Manuf Date). SoftPath GUI v
uding diagnostic; interventional procedures (such as PTCA and stent
2 placement and atherectomies); pa
ements and performing calculations to assist in determination of the
2 appropriate power and type of In
agittal; oblique; and curved cross-sectional images that display the2internal structure of the head; body
; trained; and experienced professionals. SoftID.NET supports bedside
2 collection of patient specimens u
C Soft Computer 5400 Tech Data Drive Clearwater; FL 33760.Intends
2 to provide clients with an interface
2.10 Treatment Planning System - PrecisePLAN 2.10 Treatment Planning
2
System
ss communication between the heart device and the monitor takes2place at times scheduled by the do
ve; Clearwater; FL 33760. Manufacture Dates:4.0.2.38.1 06/15/07 24.02.39.2 06/29/07; 4.02.40.1 07/19
on 4.0.4.7 Manufactured 02/03/2010. Version 4.5.1.3 Manufactured

2 03/18/2010. SCC Soft Computer 5
ation Treatment Planning System - Elekta XiO Radiation Treatment2Planning System
ecision support software device that requires knowledgeable user intervention
2
to document steps and
Integrated IT Solutions; Barrington; IL 60010. Device that receives;2stores and communicates medical i
s intended to be used as an integrated system for the planning and
2 delivery of intensity modulated rad
uding diagnostic; interventional procedures (such as PTCA and stent
2 placement and atherectomies); pa
ammable diagnostic computer intended for acquiring; digitizing; storing;
2
displaying and reviewing hem
atment Planning System - XiO Radiation Treatment Planning System;
2 Release 4.51.00.
ritical Care Manager; PACU Manager and Anesthesia ManagerSoftware:
2
CareSuite 5.1 and later
ed for radiographic examination of the standing or seated patient or
2 the recumbent patient in combina
SSH-880CV Aplio Artida System - SSH-880CV Aplio Artida System2
The intended use: the Centricity Laboratory is used to facilitate the
2 general clinical; anatomic patholog
mputer-controlled clinical chemistry analyzers designed for the in vitro
2 determination of a variety of gen
edical Systems Inc (TAMS) Digital Radiography System Radrex-i DRAD-3000E;
2
Electrostatic x-ray imagin
Image Consultant (IC) Software - Image Consultant (IC) Software2
ystem; X-Ray System. Part Number: 989605651321. Intended to produce
2
cross-section images of head
ac Software; Sunnyvale; CA. The intended use of Sequencer (generically
2
referred to as a verification sy
n. Radionuclide radiation therapy system. Elekta; Inc. Norcross; GA.Indicated
2
for use in the stereotact
147; 3217; 3014; 3050; 3068; 3188; 3091; 3051; 3099; 3126; 3183;
2 3303; 2539 & 3056.Produce crossdyssey - Odyssey Intended use: Radiation treatment planning system
2
g devices using DICOM or similar interface standards. Device options
2 enable mammography reading; te
ting Guideline 4000 ver 1.4 (GL4K) Software;Catalog # MT-GL4K.Intended
2
to assist in functional neuro
ed to be used as an integrated system for planning and precise delivery
2
of radiation therapy; stereota
e Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional
2
x-ray system.
yngo Imaging XS model number 10496279The intended use: image
2 processing radiological
ata Drive; Clearwater; FL 33760.Soft Query Results Reporting version
2 2.2.0.6.3 was released for Gener
ns 3.17 and 4.1.SCC Soft Computer 5400 Tech Data Drive; Clearwater;
2
FL 33760.Manufactured: Versio
ging - Syngo Imaging Version Lines VB20; VB30; VB35 in combination
2 with a RIS.
.6.3.1.SCC Soft Computer 34350 US Highway 19 N; Palm Harbor; FL
2 34684.Date of Manufacture:Versio
ion 4.0.4.10.1.SCC Soft Computer; 5400 Tech Data Drive; Clearwater;
2 FL 33760.Manufacture Date: 05/1
alog 300000.Indicated for delivering infusions of medications; as well
1 as providing total parenteral nut
US HEMOFILTRATION SYSTEM - Edwards Lifesciences Aquarius System
1 Model GEF09800.
94085Cardiac Compressor used as an adjunct to manual CPR. Use 3
of AutoPulse is intended to reduce th
; 6461500 and 6461500R. These product codes includes refurbished
3 units and InfusO.R. pumps previo
e monitor; and uses the device with the door closed for easy 1-2-3 2operation. When the code team arri
a physician/medical director. In manual mode; the operator determines
2
whether or not a defibrillation s
anagement of chronic intractable pain of the trunk and/or limbs including
2
unilateral or bilateral pain as
and CELL-DYN 3700 SL (Sample Loader); Manufactured by Abbott 2
Diagnostics Division; Santa Clara; Ca
evices.Communication device for the impaired and functions as a 2
speech generating device; text or sy
ELL-DYN 1700 CS (Closed Sample).Manufactured by Abbott Diagnostics
2
Division; Santa Clara; CaMedic
em for in vitro coagulation studies; Haemonetics; Haemoscope Division;
2
Niles; IL 60714; list number 07
ntgenstrasse 19-21; Kemnath; Germany 95478.The 550 TxT Treatment
2
Table is to be used as an integr
meter - Advanced Instrument Model 2020 Multi-Sample OsmometerIntended
2
to measure the osmotic pr
oxide. The pump is part of an infusion system that stores and delivers
1
a prescribed drug to a specific
NSA Shoulder Bag Tagged; c) article 57036T - Kit PNSA The Metro Bag
3 Tagged; d) article 57043 - PNSA
ted byAbbott Diagnostics Division; Santa Clara. CA and manufactured
2 in France for Abbott Diagnostics
HiSpeed FX/I - HiSpeed FX/I (2200997 with Gantry mo. #2201000)
2
33;KVDD700;KVDD701Medtronic;Kappa 800KDR801;KDR803;KDR806Medtronic;Kappa
2
900KD901;KD9
owing demand for hospital-wide; as well as alternate site and home
2 healthcare; standardization. With
ygen powers the nebulizer creating ultra-fine particles in the therapeutic
2
aerosol. The heater warms th
mmunity environments. It has been tested to RTCA/DO-160D; "Environmental
2
Conditions and Test Proce
cts; Inc.Used to prevent hypothermia and/or reduce cold discomfort2 before; during; and after surgical p
Key monitored parameters available on the models 91367; 91369; 291370 and 91387; when employing
ostic kV X-ray radiation beam-producing component that is installed
2 in a radiation-shielded vault and a
echnology. Each instrument is designed to provide accurate; reliable
2 and repeatable weight measureme
ara Generator - Philips Allura Xper Systems with Velara Generator;
2 x-ray system. FCO72200184.
pose electrosurgical generator used in conjunction with an electrosurgical
2
accessory handpiece for del
8; 9120009 and 9121009The Maxi Sky 1000 is designed for lifting patients
2
in a homecare setting; at nu
fusion System 1 is indicated for use in extracorporeal circulation of2 blood for arterial perfusion; regiona
r: CARDIOCOMMAND; INC. Tampa; FL USA. (800) 231-6370 (813) 289-5555.
2
www.cardiocommand.com.
re two models used with either the ACT 1 sensor or the ACT III sensor:a)
2
Model Ozone-HTCb) Model Bla
umo Cardiovascular System Corp; Ann Arbor; MI.The air bubble detect
2 module is used with an air senso
tilator Circuit Impact Instrumentation Inc.; 23 Fairfield Place; West Caldwell;
2
NJ 07006.Accessory for 700
e disposable blanket (i.e. FilteredFlow Blankets; Warming Tube) in contact
2
with the patient; in order to w
tion probe. Catalog Number 500AV CDI 500 Monitor with Arterial and
2 Venous blood parameter module
lin Infusion Pump - Animas 2020 Insulin Infusion Pump.Animas Corp.An
2
insulin infusion.
MPANY; INC.***www.precisionice.com***info@precisionice.com***Mailing
2
Address PO Box 27***Kingsto
g Number: 4040LC5 foot /15mm corrugated EVA hoseIntended use:2 Breathing circuit is a pediatric disp
a quantitative; automated hematology analyzer and leukocyte differential
2
cell counter For In Vitro Diag
er Traction Decompression System; Model: ME 4000Product Usage:
2 Provide traction and mobilization o
of patients in range of neonates; infants and adults with respiratory
2 failure of respiratory insufficiency;
l/Medical Light SourceThis light source is designed to supply high-intensity
2
light to a fiber optic cable fo
a Synergy XVI X-ray Volume Imaging SystemTo be used as part of radiation
2
therapy treatment process.
cation and aspiration of soft and hard (e.g. bone) tissue is desirable.
2 including Neurosurgery. Gastrointe
Intraoperative; Small Parts; Transcranial; OB/Gyn; Cardiac; Transesophageal;
2
Pelvic; Neonatal/Adult Cep
; 603 Queensbury Ave.; Queensbury; NY 12804Intended to remove2tissue and control bleeding by the u
ed as RMS voltage divided by RMS current. The amount and duration
2 of RF power delivery is user- selec
04588 Label With Guidance Module Number***PN 201251 SN GUD2XXX 2011-01***Weight 51.7kg***Cl
Baxter Healthcare Corporation; Medication Delivery Division. Product
2
code 2M8063For delivery of intr
usion Pump; Single Channel Volumetric Infusion Pumps. Baxter Healthcare
2
Corporation; Deerfield; IL; p
200.Designed for the in vitro determination of a variety of general chemistries;
1
therapeutic drugs; and
reports and provide the secondary annunciation of alarms from other
2
networked medical devices at a
sionals whenever there is a need for monitoring the physiological parameters
2
of patients. The SureSign
utschland Gmbh; Lindberghstrasse 25; Munchen; Germany.Used to2perform; control and monitor extrac
Nutrition Division; Deerfield; IL 60015The Automix Compounder Systems
2
are electromechanical positiv
ds; formal data for strip recordings and printed reports and provide2the secondary annunciation of alarm
rlando; FL 32826 Made in U.S.A.***REF 3160DCU***SN***CAUTION:

2 Law in U.S.A. Canada and EU rest
eger Medical Systems; Inc.Portable monitor used to monitor vital signs
2
of neonatal; pediatric; and adul
rian Medical System TrueBeam system for stereotactic radiosurgery
2 and radiotherapy. Model number H
w; HD1200 Autoclavable Camera HeadCatalog Number: 72203360Product
2
Usage: Endoscope & Access
ANT nbs Sickle Cell Program is intended as a qualitative screen for the
3 presence of hemoglobins F; A; S;
ator & Software; Model 6482.Distributed by Boston Scientific; 41003Hamline Avenue North; St Paul; MN
381 are intended to provide stereotactic radiosurgery and precision
2 radiotherapy for lesions; tumors; a
4 and STAR S4 IRTM Excimer Laser Systems; which are indicated for
2 wavefront-guided laser assisted in
European UnionLATITUDE 6.2 Patient Management System WebsiteServer
2
software; Model 6441 for Can
viders in hospital and clinic settings.Affected Product Part Numbers:2 3202487-000 thru -012; 3202487-0
2 Control - i-STAT Level 2 Control Value Assignment SheetsHuman2Consumption
tpatient clinics; free-standing surgical centers; and other alternate 2care facilities. Physiologic data inclu
nd endotracheal or tracheostomy tubes using the mainstream function
2
of the module.The intended use
el DxC 600 or DxC 800 Synchron Clinical System is a fully automated;
2 computer-controlled clinical chem
MetHb; HHb) parameters. Total bilirubin can also be quantitated from
2 heparinized plasma samples whe
ogy Analyzers; Part Number: 6605522; 6605523; 6605524; 6605525;
2 6605526; 6605527; A85566; and
- Welch Allyn PIC 50 Portable Intensive Care System. Model 971081
2 series.Designed for use in and ou
d Hematocrit/Saturation probe; Catalog 500AVHCT; Terumo Cardiovascular
2
Systems Corporations; Ann
indicated for use to display patient blood gas values during extracorporeal
2
procedures. The CDI 500 sy
cians with patient physiological data; while allowing for patient mobility.
2
These systems are typically d
Sign elance Monitor; Model 93300Spacelabs Healthcare; Llc.A vital2signs patient monitor with arrhythm
Hg. The Pressure Display Box has an upper and lower alarm setting.
2 The alarm will be activated when
dditionally; CT & PET data from a respiratory tracked examination may
2
be used to allow the user define
Release 2.1.0 and aboveUsed to create treatment plans for any cancer
2
patient for who external beam
Release 1.0.2 and above.Used to create treatment plans for any cancer
2
er 107493; Indicated for continuous solute and/or fluid removal in patients
2
with acute renal failure or fl
DIASAFE PLUSPart Number 190713; 2008T Hemodialysis System with
2 CDXPart Number 190766; 2008T
ns; CDI 100 Hematocrit/ Oxygen Saturation Monitoring System. In-line
2
blood-gas sensor used in cardio
ct is manufactured in France for Abbott Diagnostics Division of Abbott
2 Laboratories; Abbott Park; IL The
pitas; CA 95035Iris registration is designed to compensate for pupil
2 centroid shift and cycloration; both
gen Saturation Monitoring System is intended for use during cardiopulmonary
2
bypass procedures whe
cessing; filming and media interchange of multi-modality images from
2
a variety of diagnosis imaging s
n; Model 5.34.Intended to be used for planning the dosimetry of treatments
2
in stereotactic radiation th
gy XVIIntended use: Radiation therapy treatment of malignant neoplastic
2
diseases; as determined by a
oenix x|ray v|tome|x series cabinet x-ray systems are used in non-destructive
2
testing; failure analysis;
ient by monitoring linear accelerator set-up parameters and by preventing
2
the radiation therapy devic
or harmonic imaging and 3d/4d imaging on a flat panel display. The
2 device system is intended for the
non-Siemens linac interface.System components include: LANTIS 2
Commander; LANTIS system; LANTIS
VI 4.5Product Usage: Radiation therapy treatment of malignant neoplastic
2
diseases; as determined by
sound transducer designed to help clinicians perform adult echocardiography
2
and pre-operative and in
erization laboratory through calculations of physiologic equations. 4000-a
2
portable bedside whole blood
o auto setup the machine to predefined settings. The actual settings
2 are read from the treatment mach
ystem - MOSAIQ Oncology Information SystemIntended Use : Electronic
2
Patient Records Management
soft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED

2
FOR NEUSOFT MEDICAL SYSTEM
han 2.4.0 and less than 4.63.0The XiO RTP System is used to create2 treatment plans for any cancer pat
ton TX 77098OBLink provides automated transmission of patient data
2
and measurements from ultraso
mote Cardiology Review Station; a cardiovascular information system.
2
Model Number CV7.8
toring SolutionNetworked solution/system used to monitor patients'
1 vital signs and therapy; control ala
101101; 5102161007; 5103221007; 5104221007; 5105101008; 5109131010;
3
5111231011; 511430101
uted by Siemens Medical Solutions Oncology Care System; Concord
2 CA Medical charged-particle radiat
o Alto; CAProduct Usage: 4D Integrated treatment console is designed
2
to assist the operator of a radia
d to deliver megavoltage x-ray treatments for conventional radiotherapy
2
(three dimensional conformal
R) for the amplification of Factor II DNA recovered from clinical samples
2
snd fluorigenic target-specific h
n is to acquire primary or secondary harmonic ultrasound echo data
2 and display it in: B-Mode; M-Mode
ftware package used with general purpose computing hardware to2acquire; store; distribute; process a
nd Business Unit; Mountain View; CAThe ACUSON SC2000 ultrasound
2 imaging system is intended for th
eet the growing demand for hospital-wide; as well as alternate site2and home healthcare; standardizat
(R) Delta; Delta XL; Gamma XXL and Kappa Monitors are used to monitor;
2
physiologically; the vital sign
1 Wallace Drive; Suite 150; Carrollton; TX 75006The Outlook ES pump
2 is intended for use with B. Braun
anning System;Varian Medical Systems; Palo Alto; CARadiotherapy2treatment for patients with maligna
Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology
2
Analyzer provides automated
e. A patient record is populated with information from various sources;
2
such as health care professiona
em is Medical Diagnostic Ultrasound.General purpose ultrasound system
2
intended for use by a qualified
rsions with build numbers from 7.3.10 through 8.6.15 (i.e. excluding
2 8.6.17); Model Number: H48; Radi
enous oxygen saturation); impedance respiration; airway gases (C02;
2 02; N20 and anesthetic agents);
urbished; with or upgraded to; version 4.6 or 5.1.0 software.The Cirrus
2 HD-OCT is a non-contact; high re
Systems; Des Plaines; IL 60018; part numbers 110-0199G2; 110-0199G4;
2
110-0234G1 and 110-0234G3
ay; processing ; archiving; printing; reporting and networking of NM
2 data including planar scans (Static
an radiotherapy treatments for patients with malignant or benign 2
diseases. Eclipse TPS is used to plan
ning System - Eclipse Radiation Treatment Planning System; model
2 H48;Varian Medical Systems Inc..
kinson; San Jose; CA 95131CellQuest Pro software allows you to acquire
2
and analyze data from your flo
tor of a radiation device in providing accurate treatment set-ups for
2 each patient by monitoring set up
0 is intended for use on adult; pediatric; and neonatal patients and
2 on one patient at a time. The CARE
eter monitoring system 500 with Arterial and Venous blood parameter
2 modules and Hematocrit/Satura
use: The 4D Integrated Treatment Console function is designed to2 assist the operator of radiation the
maging device - Acuson Antares Ultrasound Imaging System with software
2
versions 4.0 and 5.0.
eflectable tip catheter to deliver radio frequency energy during cardiac
2
ablation procedures.Stockert 70
d or mobile mounting option; running either DataCaptor continuous
2 or periodic connectivity softwareT
version) and (240-050-810; DVD version) designed for digital documentation
2
of medical procedures.
de to prevent having to listen to false alarms. Spacelabs Healthcare
2 patient monitors are intended to a
Fetal; Abdominal; Intraoperative (abdominal and neurological); Pediatrics;
2
Small Organs (breast; testes
m is used to plan radiotherapy treatments for patients with malignant
2 or benign diseases. It is used to p
W) versions F.01.00 or F.01.01 and with all of the following hardware2 options EtCO2; IP and Temp.Used f
ominal; intraoperative; pediatric; small parts; neonatal/adult cephalic;
2
cardiac; transesophageal; pelvic
cation of correct patient position in relation to isocenter and verification
2
of the treatment fields relation
he Essential system is intended to be used in the same clinical applications
2
as traditional mammograp
tional images of the body by computer reconstruction of x-ray transmission

2
data taken at different ang
BuckyDiagnost general purpose x-ray system with Optimus Generator.General
2
Purpose Diagnostic Radi
ed for the following applications: Fetal; abdominal; Intraoperative;2Pediatric; Small Parts; Transcranial;
are Version 8.0.1; 8.3; 8.3.1; 8.3.2IQecg is to be used; under the supervision
2
of a Physician; to obtain E
ar and neurovascular imaging applications; including diagnostic and
2 interventional procedures. This inc
ease 4.2.0 and aboveUsage: Used to create treatment plans for any2 cancer patient for who external be
2
California 94304-1038.Used to plan radiotherapy treatments for patients
2
with malignant or benign dise
2
1.5H; 1.5.1A and 2.0Q -Field Test PeriodA nuclear medicine image display
2
and processing application su
ter assisted surgery based on a wireless optical tracking localization
2 device for the use in navigated cra
ease 4.3.0 through 4.50.00.Used to create treatment plans for any2 cancer patient for who external bea
are fully automated and computer controlled instruments designed
2 for the in vitro diagnostic quantita
hemistry; specific protein and electrolyte tests. Analytes are measured
2
photometrically or turbidimetri
Release 1.5.0 and above.Used to create treatment plans for any cancer
2
8 USA; catalog #09K15-01The Abbott m2000rt System provides for2 real-time measurement of the stag
the rapid detection of bacteria and fungi in clinical specimens. Samples
2
are drawn from patients and i
nts. The TotalCare Bed System may be used in a variety of settings2 including but not limited to; acute
may be used in synchronized mode to terminate certain atrial and2ventricular tachycardias and other
System; REF: 61000; Caridian BCT; Lakewood; CO 80215.A blood component
2
separator used for therap
point of health care delivery in a clinical setting. The instrument provides
2
quantitative measurements
process of process of patient treatment on a radiotherapy treatment
2 machine. It gives the capability t
Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small; 2
lightweight unit designed to take blo
hrough 4.40.00.Used to create treatment plans for any cancer patient
2 for who external beam radiation
g methods. The Focal software allows users to access XiO and other
2 RTP systems from a remote PC-bas
n an acute or chronic facility. The 2008K@home is also indicated for
2 hemodialysis in the home and mu
WITH FUNCTOOL OPTIONGE Medical Systems; SCS.A software module
2 that provides supplemental infor
www.medical.philips.com... Philips Medical Systems Nederland B.V".Provides
2
one or more capabilities r
se High Frequency Ventilator; Catalog Number: 203A; Manufactured
2 by: Bunnell Incorporated Salt Lake
anufactured and distributed by Varian Medical Systems Inc.; Palo Alto;
2 CAProduct Usage: 4D Integrated
eckman Coulter UniCel DxI 800 Access Immunoassay System with 2
Unicel DXI system software version 4
al Systems Inc.; Palo Alto; CA Optical Guidance Platform is for use with
2 a charged particle accelerator to
uted by Varian Medical Systems Inc.; Palo Alto; CA Optical Guidance
2 Platform is for use with a charged
arian Medical Systems Inc.; Palo Alto; CA.For use with a charged particle
2
accelerator to perform precise
r module determines (a) when an alarm condition is violated; (b) the
2 alarm priority (i.e. high; medium
rtable; automated analyzer that measures pH; blood Gases; electrolytes;
2
glucose; lactate and oximetry
elease 4.50.00 and aboveUsed to create treatment plans for any cancer
2
quilion 32/64 - TSX-101: Aquilion 32/64; System; X-Ray; Tomography;
2 Computed.
s Computed Tomography X-ray system is intended to produce cross-sectional
2
images of the body by co
ntouring methods. The Focal software allows users to access XiO and
2 other RTP systems from a remote
ended for use in data collection; storage; and management with independent
2
bedside devices; and anc
nd System - Acuson Antares Ultrasound SystemDiagnostic Ultrasound
2 system
anagement application that is intended to receive; transmit; store;2 retrieve; display; print and process
ts; nurses; physicians and therapists and for use in a laboratory environment;
2
near patient or point-ofons found in clinical laboratories. The UniCel DxH 800 Analyzer provides:
2
- Complete Blood Count (CBC
ons found in clinical laboratories. The UniCel DxH 800 Analyzer provides:
2
ons found in clinical laboratories. The UniCel DxH 800 Analyzer provides:
2
re cells; tissue; bacteria; fungi) using the specially designed MagNA
2 Pure LC kits; for the purpose of life
and a tube for each drug; as well as a barcoded tube carrier that holds
2
the set. The carrier barcode prov
art - Varian Medical Systems; Varis Vision - RT Chart version 7.3.10.2For radiation therapy.
elease 4.50.00 and aboveUsed to create treatment plans for any cancer
2
s version 1.00 and is distributed on USB pen drives. These pen drives
2 are lot number controlled and de
5047 IntelliVue Clinical Information Portfolio Release D.03; 865209 2IntelliVue Clinical Information Portfol
model number 10433816.Siemens Medical Solutions USA; Inc.Business
2
Unit Ultrasound1230 Shorebird
R1500-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER;
2
MC-SYS-SR1500-D-UPG-INTL
otactic radiosurgery to tumors or other targeted tissues while minimizing
2
the delivery of radiation to v
ular suite is a cardiovascular information system providing image archiving
2
and image display and mod
ing methods. The Focal software allows users to access XiO and other
2 RTP systems from a remote PC-b
uring methods. The Focal software allows users to access XiO and 2other RTP systems from a remote PC
ps console base: P/N 917751Intended for use as an extracorporeal 2
circulation device for perfusion lastin
Character Recognition (OCR) The IMPAX Cardiovascular suite is a cardiovascular
2
Information system p
ed to guide a clinician in the proper implant selection; oral placement
2 and the proper selection of an or
The EVOLIS Assay Protocol Files (APF) Software contains assay-specific
2
instructions necessary for the E
de of the balloon. Arctic Front Cardiac Cryoablation catheters are introduced
2
into the vasculature by tra
y Bio-Rad Laboratories; Hercules; CA.EIA and IFA processing system
2 that consists of a PhD fluid handlin
uring methods. The Focal software allows users to access XiO and other
2
RTP systems from a remote PC
dated to utilize the RT Therapist v4.1 software.Siemens Healthcare;2Concord; CA.The intended use is to
any.Distributed by Siemens Medical Solutions; Concord; CA 94520.Product
2
Usage: Linear Accelerators
CThe expected usage of these devices is for fluoroscopy studies for2various anatomical regions of the h
ical Low Coherence Reflectometer) Biometer used for obtaining ocular
2
measurements and performing
Intended to produce images depicting the anatomical distributions2of single photon emitting radioisoto
R Eleva Radiological Image Processing System with software R.1.2 2Philips Healthcare; Inc.A computed r
X-ray system featuring a continuously rotating X-ray tube and detector
2
array with multi-slice capability
n. Instrument Manager also provides data management functions that
2 aid in the interpretation and man
long term and short term change values. This includes sBMD (mg/cm2).
2
The XR 46 performs soft tissue
LIPS NM3 Monitor; English; Demo Unit - P/N DU1051674PHILIPS NM3
2 Monitor; Spanish - P/N 1060462NM
F; etc. Vital connect has the following intended use: Vessel Probe is2intended for viewing the anatomy a
arametric maps; and/or dynamic images of the structures and organs
2 of the entire body; including; but
4.2 system;Therapist Express Basic; syngo RT Therapist and syngo
2 RT Therapist Connect/MOSAIQ OIS
Tomography; Computed - TSX-301B: AQUILION Premium; System; X-Ray;
2
Tomography; ComputedX-Ray
PC-based system and provides the user with the ability to edit and 2modify patient data form a Windows
CA.Intended for General Radiology; Fetal; Abdominal; Intraoperative;
2 Pediatric; Small Parts; Neonatal/A
ist Assist or Therapist Express Assist workspace with software version
2
NET VA10A for RTT 4.1.122 or N
ables the user to document steps in the receiving and processing of2 surgical; gynecological; medical cy
x PC software application; Hospira; Inc.; Lake Forest; IL 60045; list 213092-04-01A stand-alone PC applic
onaco Release 2.03.00 and aboveTo create treatment plans for any2 cancer patient for whom external b
ng clinical chemistry; specific protein and electrolyte tests. Analytes

2 are measured photometrically or t
OB-Windows provides professional reporting and analysis of fetal growth
2
throughout the gestational pe
ntrolled remote electra/mechanical system used for medical purposes;
2
for placing a NiTiNol wire incorp
st v4.2 systems.Manufactured by Siemens AG; Medical Solutions; Kemnath;
2
Germany.Delivery of X-ray
ite is a cardiovascular information system; providing image archiving;
2 image display and modality/stud
d impressible; reusable; critical and semi-critical heat sensitive medical
2
devices; including endoscopes
atment Planning System; Software version 3.0; 3.1; 3.5.0; and 3.5.1.For
2
the treatment planning and im
user to document steps in the receiving and processing of surgical;
2 gynecological; medical cytologica
mobile software controlled diagnostic ultrasound system and on-screen
2
display for thermal and mechan
er 159001;Neonatal Software catalog number: 159700; Neonatal Option
2
catalog number: 159187. Ham
ion; and results distribution. The IMPAX 6.5 Client focuses on the integration
2
of PACS; RIS and Speech a
gement of compounding; creating and authorizing nutritional solutions
2
intended for IV administration.P
Monaco Release 2.03.00 and above. The Monaco RTP system is used
2 to create treatment plans for any
ed for use as an adjunctive therapy in reducing the frequency of seizures
2
in adults and adolescents ov
0Intended for high speed cutting; sawing; drilling and manipulation
2 of soft tissue and bone in the fields
on Medtronic StealthStation systems.Product Usage: DICOM Query/Retrieve
2
software enables the use
O 420 CPG 8K; Catalog Number 816373The Sarns 8000 Cardioplegia
2 Monitor is indicated to measure ex
tware is included in a number of Baxter's pharmacy compounders.2The software assists the pharmacis
2102 (IDE).This product is a lead less non-therapeutic implantable2cardiac monitor and is implanted to
ms with RTT v2.x AND an ARTISTE Linear Accelerator/RT Therapist v4.1
2 system with the LANTIS OIS.The
EMOCUE AB Hb 201 DM ANALYZER; in vitro diagnostic device for quantitative
2
hemoglobin determinatio
Elekta Synergy XVI R.4.5 and R4.6ProducT Usage: To be used as part
2 of radiation therapy treatment p
ease 4.0.0 through 4.40.00Used to create treatment plans for any2cancer patient for who external bea
6.5; Digisonics; Inc.; 3701 Kirby Drive; Houston; TX 77098; Tel: (800)
2 940-3240; Fax: (713) 529-7999So
version 3.5Medical charged-particle radiation therapy system; intended
2
for treatment planning and im
mical structures and for analysis packages that provide information2 that is used for clinical diagnosis p
s a digital image management and reporting system with an associated
2
clinical database. It provides c
98; 800-940-3240.DigiView is a digital image management and reporting
2
system with an associated c
RIO System - The Tactile Guidance System v2.0 is intended to assist2 the surgeon in providing software d
ec CRC 25 PET; item number 5130-3217 with Software Revisions 2.01
2 and 2.02PET dose calibrator
m to be used in a medical research or clinical laboratory by knowledgeable;
2
trained; and experienced p
ther third party devices. The TCAutomation is a pre-analytical and2post-analytical sample managemen
formation from various sources; such as health care professionals;2medical devices connected to the s
o Release 2.0.1 and aboveUsed to create treatment plans for any cancer
2
Coherence Dosimetrist; version 2.2.Intended use: Medical charged-particle
2
radiation therapy system
bshealthcare.com***".The Reynolds Pathfinder 700 Holter Analyzer
2 is intended to be used to analyze m
Planning System - XiO Radiation Treatment Planning System; XiO Release
2
4.50.00 and above
: Version Blue; Service Pack 2.The WaveLight FS 200 Laser System2 is an ophthalmic surgical laser indi
ew and modify layouts specific to users' needs. 5. The ability to modify
2
elements of reports using the c
through 1.0.2. Used to create treatment plans for any cancer patient
2 for who external beam intensity
Aplio Artida Ultrasound Diagnostic System SSH-880CV.Toshiba American
2
Medical Systems; Inc.A diagno
for any cancer patient for who external beam radiation therapy has
2 been prescribed. It is an accessory
st 4.2.The ONCOR and PRIMUS may be updated to utilize the RT Therapist
2
v4.2 software. The RT Oncolo
ONE - Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) - Whole Body

2 X-Ray CT Scanner
s MultiDiagnost Eleva is intended use as a multi-functional universal
2 system; general RF; Fluoroscopy;
Used when planning and performing prostate brachytherapy implant
2 procedure. It provides ultrasound
hines.Sequencer Verify and Record System is to assist in the process
2 of patient treatment on a radioth
a; System; Diagnostic Ultrasound - SSH-880CV Aplio Artida; System;
2 Diagnostic Ultrasound
ng and communication system intended for acceptance; transfer; display;
2
storage; archive; and manipu
A: Aquilion 64 - CHVH-001A/1B Variable Helical Pitch (vHP) Software2 for TSX-101A: Aquilion 64; System;
methods. The Focal software allows users to access XiO and other 2RTP systems from a remote PC-base
ations system intended for acceptance; transfer; display; storage; 2
archiving and manipulation of digita
Aplio Artida - Software for SSH-880CV Aplio Artida; System Diagnostic
2 Ultrasound
s and/or spectra in any orientation of the internal structure of the head;
2
body; or extremities. Image ap
d to facilitate the general clinical; anatomic pathology and cytology
2 laboratory workflow such as order
heral vessel; Biopsy; Trans-rectal; Trans-vaginal; Musculoskeletal; Neonatal
2
Cephalic; Adult Cephalic; En
OCUE AB GLUCOSE 201 DM ANALYZER; in vitro diagnostic device2for quantitative determination of bl
subsystem produces images of the distribution of PET radiopharmaceuticals
2
in the patient body (spec
coDiagnostiX; dental implant planning system. Software Version 7.0
2 including updates 7.0.2 and 7.0.2
ation that is used for receiving; managing; archiving; distributing and
2 recording medical images onto p
House; Farleigh Wallop; Hants; UK RG25 2HT.Indicated for 3 Lead ECG
2 monitoring and 12 Lead ECG rec
ment unit set-up parameters and estimates of dose distributions expected
2
during the proposed treatme
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Reason_Recall
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ed
release
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voltage
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ce loss of power
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in ablation mode.
ent
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customers.
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letter describes
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issue,
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6 Plusthat
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a GE representative
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and
10/10/2006.
a small amount
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clusions.
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IV administration
letters included
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have
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number
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ould
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nt
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battery depletion without
Non-implanted
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ed the
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its notification
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could cause a reduction of power; caus
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component
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likelihood that
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formation
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or This
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2006 Productthresholds
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circuit
2006
and
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Mail,
shock
Return
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nted
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consignees
board have
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Servicewhen
Engineer.
the torso
For further
of the patient
question
is
customer.
ne List" function;
The letters
the "Anatomic
provided the
Pathology"
users with
application;
specific safety
and the
instructions
Instrument
to follow
Interface
until
IOthe
module
software
that wa
m
ents are done sequentially; record incorrect values. The recorded value is displayed to the user on a re
e GlucoseThese
201 DM
andcodes
Hb 201
DM
analyzers
in the
The affected
units in the
field will be
opriately.
error
are:
E01;
E02 andthat
E05are
which
arefield.
all related
to the optronic
performance
o
o support
recur; it concerning
could impact
this
the
upgrade,
performance
contact
or the
reliability
Customer
of the
Care
system.
Solutions
Philips
Center
is issuing
at 1-800-722-9377.
a software update
xpress
cur when
Delivery
the implant
Service.
length
The is
upgrade
changed
is available
after positioning
on-line by
thelogging
surgicalinto
sleeve.
the coDiagnostiX system and
measurements
For questions
on true size
on printouts
this recallmay
contact
be inaccurate
Philips representative at (800) 722-9377.
were
ECG attached
is recorded
with
and
the
monitoring
letter depicting
is quickly
the restarted;
conditionsthe
under
ECGwhich
can cease
the issue
functioning.
can occur. Customers can
symptoms
Affairs Manager
involve
atthe
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366 110and
or david.hedfors@raysearchlabs.com;
Image Position attributes in the RT images
RaySearch
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andatits
888-838-3222
requested test
in results
the US could
or 33 occur
5 63 82
when
53 19
running
outside
in of
batch
the US
mode
for and
any cartridges
questions regarding
are introduced
this
were
d youshipped
have any
with
questions
a different
or require
software
additional
version from
information,
what theplease
customers
call (714)
ordered.
427-5811 extension 344.
tch that do not result
Should
in a you
resethave
of the
any
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questions,
Enable button;
please call
and(425)
emissions
482-1100.
can resume after a standard
ructed
es not not
calculate
to usethe
theCreatinine
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calculate Creatine
correctlyClearance
for patients
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does NOT interlock beam delivery.
face;
this recall,
the Horizon
customers
Cardiology
should ECG
call the
Management
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Support does
department
not display
at 1-866-777-0202
the amplitudes and
of the
speak
wavefor
to t
sterEOS image review
Questions
station may;
can be
in answered
certain cases;
by calling
be affected
33 1 55
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7 compliance verification; an issue was identified
- Close
byt.PerMedics engineers in three export files: D1COM
ssing
uestions
a preliminary
should be directed
result instead
to their
of GE
theService
final result
Representative
from the Process
or theSystem
GE HelpManager
desk at when
888-778-3375.
there is a
rogrammed with unapproved
All affected software
devices were
was distributed.
returned to the firm as instructed.
nts
rther
of explanation,
the fax reports;
please
theyconsult
found one
your
ofSCC
the representative
specimen diagnoses
for further
to bedetails,
missing.
orParts
call (727)
A through
789-0100.
D were
customers
tment datatofrom
file the
Desktop
letterPro
in the
R7.01
Important
to R&V Notice
system;
section
the XVI
ofinformation
the appropriate
is prioritized
User Manual.
and the
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end of
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tr
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y Task recovery
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from System
certain On
types
03/22/201.
of table access
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conflicts.
have received
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a hot
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fix thatoccur;
corrected
this function
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o
nical
m angle
impact,
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and
to the
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workaround
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beam angles
(VERIFY
are selected
USE NOTICE
via Monaco
DATE) Asoftware;
return postcard
the beam
was
angles
included
wil
orrection
s. Additionally,
to several
device
of their
operation
GEMINI
information
PET/CT X-ray
is provided
system units
to customers.
in the field.
A Philips
The firm
Field
believes
Service
that
Engineer
if thes
For further
please callin(781)
yed one patient's demographic
andquestions
health information
place557-3000.
of another patient that was in current v
mage
he user
artifacts
stop running
that could
the possibly
MAR application
lead to aon
misdiagnosis
any of the affected
of patients
Brilliance
who have
systems
small identified
metal implants.
with the
the
5 for
field.
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The firm Systems".
believes that
Enter
if these
your site
software
ID number.
defects
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you do
tonot
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impact
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the performan
hold an
nge would not be reflected in echocardiography formulas used within the Adult echocardiography RM.
heir Brilliance iCT and Brilliance
For further
ICT
questions
SP CT X-ray
please
system
call units
(440)in483-7000.
order to correct non-conformances evi
testing of Brilliance 64 and Ingenuity CT software version 4.0 Beta 2. The non-conformances are due t
m,
ed and
a layout;
actions
thetosystem
be taken
didby
not
the
load
customers.
the layoutThe
with
hot
the
fixes
previously
that were
saved
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value inloaded
the NewPage
which introduc
proper
tion
integrated
please workstation
contact the Customer
listed above.
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The problem
Support
is at
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1-800-854-3633,
to numericalorIntrinsic
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Beckman
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pro
de;
ips the
representative
system wasor
not
local
recalibrated
Philips Healthcare
with the infant
office for
phantom
North America
for the infant
and Canada
protocol.
contact the Custom
d
ase
Tomography
Notes which
X-ray
were
Systems
provided
equipped
to each with
customer
software
location
version;
once3.5
theBeta1.
software
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non-conformances
is installed. The
stem
le
sotope
ons or is
assistance
peaked. they
Therewere
is a instructed
potential patient
to contact
safety
Siemens
issue when
Medical
running
Solutions
syngo
USA,
MI Applications
Inc. at (800) version
888-74
mote
displayed
interrogation
on the website.
of the implanted
Boston Scientific
device. These
detected
occurrences
that a payload
resulted
failure
in non-displayed
had occurred,payloads
but could
bec
no
etter
ion toadvise
obtainallancustomers
ETCPD that
to matches
follow any
previous
instructions
clinical
or prescriptions;
recommendations
which
covered
in turn in
could
the lead
Notice.
to a
The
presc
let
to
orcustomers
earlier may
consisting
cause anof
affected
a software
AEDdata
to cancel
card, shock
instructions
duringon
the
how
charging
to perform
process
the upgrade, and a pre
er(LEDs)
to schedule
pumpsthe
stop
field
infusing
correction.
and a The
backup
correction
alarm sounds;
consistsbut
of revising
the "Run"
the
LEDs
Dooradvance
and Main
asProcessor
if the pumps
soft
he medication.
B. Under
Braun certain
Medicalconditions
Inc. notified
in consignee
a network environment;
by letter on August
Management
24, 2010.
Processor may becom
mphasizes the importance of checking battery voltage prior to implant as stated in device labeling. Fo
hey are affected by the recall, and to only use the computer on AC power until they have requested an
04/21/2006.
GE representative will contact affected accounts to arrange for the vaporizer exchange at no charge.
also notified by fax and e-mail and a phone call on the same day.
ence of these potential problems, and included a copy of the Battery Usage Guide, Infusion Manageme
instructing replacement of the power pack every two weeks until further notice.
hich Medline will replace with a newer version of the controller. Any questions were directed to 800-28
ected site and schedule an upgrade with the revised firmware.
91--876, below R0036. Once completed, the firm has supplied their customers with a TELEFAX form to
have received the device. The letter describes the issue and provides recommendations.
The customers are provided additional guidance if they see certain symbols as described in the letter.
endations. Non-implanted inventory is being retrieved from hospital shelves and Guidant Represenata
nted is attached to the letter. The letter also provides medtronic''s website in which regular updates o
nclosed.
tter also advised customers what to do when readiness indicator displays certain symbols. The firm''s
ted to review the enclosed list of serial numbers for accuracy and telephone Baxter at 1-800-843-7867
with additional force. The users are to contact Philips for replacement. The devices can be used unti
er to arrange for a convenient time to install the software update. Along with the letter, the customer
the recall and requesting the product be returned.
ample on Appendix IV). The serial number of the power supply destroyed will also be recorded on the l
or instructions on performing a baseline 'save to disk' and provide this information to Guidant. Guidan
ntenance visit. Should the customer wish to have the modification performed prior to the representat
how to have the monitor repaired. Smiths Medical MDPM requests that an acknowledgement form be
er to arrange for a convenient time to install the software update. Along with the letter, the customer
ocate affected devices and remove them from service. A new AED would be sent to the customers and
were notified by letter on 09/07/2006.
e issue, states that Guidant is retrieving all non-implanted devices and that Guidant is currently conduc
beginning October 30, 2006, was also sent to provide an update that further laboratory testing and a
uested to return unit for repair or replacement.
audit the device recall records for completion.
m and of their completed corrective action on 8/14/2006, by a Service Rep visit.
to inspect their PIC 50 units for the affected serial numbers and return the identified units for servicing
d to respond to the notification witihin 5 working days by faxing or mailing the enclosed response form
structions to Mitigate Risk. A software upgrade to: version D.00.61 and Sp02 FW A.01.46 is mandatory
structions to Mitigate Risk. A software upgrade to: version D.00.61 and Sp02 FW A.01.46 is mandatory
roblem and instruct them to return the cables or apply corrective labeling. .
grammed in combination with automatic or manual ORDAC for a GLUCm test. Customers are requeste
ts. As a result the ARCHITECT system software is unable to track how long the reagent kit has been sto
monitors. in. combination with automatic or manual ORDAC for a GLUCm test. Customers are requeste
grammed
ppears
in the Cytometer Status, an audible alarm sounds, the run aborts, the carousel ejects, and the s
ffected products and providing instructions on the recall.
d products and providing instructions for the corrective actions.
ntory.to
DONE
ested
provide this information to their customers on 12/15/04, but Terumo has not yet received confi
2006 and initiated their recall on June 1, 2006. The US distributor has issued a Medical Device Field C
combination
with
automatic
or manual
ORDACinstructions
for a GLUCm.
PROCESS
ng them of the
affected
product
and providing
onIN
the
recall.
ntory. DONE
ogrammed in combination with automatic or manual ORDAC for GLUCm. IN PROCESS
combination with automatic or manual ORDAC for a GLUCm. IN PROCESS
mit
corrections
removal
report.
DONE
msinitial
customers
of the and
potential
problem
and
provides a suggestion to avoid this issue.
ogrammed
in
combination
with
automatic
or
GLUCm.
PROCESS
conjunction with functioning anesthetic agentmanual
monitor.ORDAC
In thefor
long
term aIN
GE
Healthcare representative
the device if it locks up. The letter also states that the firm will be performing upgrades of the devices
mit initial corrections and removal report. DONE
16-17, 2006. Customers were instucted to not use the device in-line with a defibrillator/monitor.
veinvestigation
and return the
product.
e
results.
IN PROCESS
nts, Respironics will loan them a PLV 100, 102 or 102b Ventilator with no charge. If patient support goe
stomers
are recommended
to not use the measurement in question 'PG Mean' for any diagnostic or the
e investigation
results. IN PROCESS
esponse from the Response form provided. This check enables us to ensure that users have received th
made to assure the calibration status and QC is being performed. A new software version is scheduled
esponse from the Response form provided. This check enables us to ensure that users have received th
t. 12, within
2006, the
to arrive
at thebeen
physicians'
offices
Oct. 13th. units are still in the process of being upgra
units
U.S. have
completed
andon
international
mplete the software upgrades within six months.
are update is available. Customers are asked to respond back to Metronic with an enclosed Acknowled
approximately 50% of exported units have been upgraded.
various St. Jude offices and local distributors with this information being fed back to St. Jude Medical C
e. This anomaly does not affect device safety or effectiveness but Medtronic will re-program them upo
ner
is empty
without
thetosystem
immediately
indicating
that
the supply
empty. IfThe
they
are running
Sy
software
version
V5.21
the new
version V5.23,
in order
to correct
thisisproblem.
Service
Personne
h discs to perform the software update. All field changes will be documented via Service Work Orders.
ydvisory
Servicecan
Bulletin
DD+DIS225.06E.
be found
on St. Jude's website, www.sim.com
ered by Siemens Medical Solutions field service personnel by 1/6/2005. .
ds that
Installation
software version
2.2.2
or greater
mandatory.
To ensure immediate upgrade to v
and Health
Careof
Professionals.
Press
release
issued is
1/17/06.
.
r distribution to the end user facilities (medical facilities).
er its initiation.
meaning.
Newwash
software
will
be installed
in all
metersinwhen
it becomes
compromised
buffer
delivery''
or ''Air
detected
the wash
buffer available.
supply line'' To prevent out-of-b
meaning. New software will be installed in all meters when it becomes available.
meaning.
New software
will be installed
in interruptions.
all meters when it becomes available.
7197 will eliminate
unnecessary
workflow
king the week of 07/24/06. Additionally, Philips included with the Urgent Device Correction Notice a pro
d to complete and return the enclosed response form within 10 days so that the firm can be assured th
o consignees via Federal Express. .
Surgery, Anesthesia, ICU, Nursing, Risk Management and Biomedical Engineering.
another letter in January 2007 detailing the plan to provide software upgrade.
e attempts to contact the account by phone and complete the recall process.
oftware versions v3.8 and earlier, provides short term recommendations and a long term solution of up
ct the consignee to make arrangements to install new software. On 10/19/06 the firm mailed an ident
ay on the screen when prior data exists and a new patient is being registered.
red upgraded software.
o alert them of additional monitoring requirements if a PEEP setting of less than 2.5 mbar is used .
diable the glucose and lactate channels or remove cartridge. A software upgrade will be released in ea
1.20 and monitor software to version 2.2.1. U.S. software has all been upgraded and international upg
ated September 5, 2006, informs customers of this issue and provides recommendations to avoid its o
ineers visited each customer location and installed software upgrades. Version 3.831 software was ins
Technician. During the visit, the necessary corrective software will be installed. The visits/corrections
avoid potential erroneous results. Firm targeting 75% effectivenss checks.
C System past 14 days. They also were instructed to complete and return the enclosed response form.
until the new software version is installed. Customer Bulletins were prepared and sent to the Branche
occur when running a Work list with missing tube Location(s) in Automatic MCL mode. The letter outlin
cknowledge receipt of the Safety Alert. A Field Service Engineer will visit to install the revised software
ning June, 2004.
m solution as a software upgrade that will correct this situation. A reply card is asked to be returned to
the customer ever re-activate/install their system(s). The second letter, issued to the customers with a
ce from 3/12/2005 thru 4/15/2005. The Field Reps. of Radiometer America reported to Radiometer Med
This informs customers of the potential problem and provides a recommendation to avoid this issue.
on. If the corrected software has not been installed, the firm''s Field Service Engineers will install softw
continue to use the afterloader devices if following the listed cautionary statements. A software upgra
Customer Bulletin and Confirmation Form (FaxBack) were prepared and sent to the affected Bayer Heal
orrected the problem was installed on affected systems via Field Modification Instruction (FMI) 80114.
then once more (if needed) in order to determine the rate of response from the Response form provid
Processing functionality SWAT (Synapse Web Administration Tool).
ns to upgrade via telephone and email on 10/13/2006.
rred to as release 3.0. The firm advised its clients that the installation of this software to their system
re update will be issued no later than September 2006 to correct the problem.
w to verify that the image calibration data was correct.
m actions to take to mitigate the anomaly until the new software version RenalSoft V.2.0.x can be issu
tative will conduct and document the corrective action during a visit to the customer.
ll be installed starting the first quarter of 2006 and be completed by the third quarter of 2006. .
es. 1/24/2005.
sed a service representative will visit the consignee to install a new software upgrade.
gineer will visit affected sites to hand-deliver this letter and to delete any affected scan protocols, whic
ated the letter for their customers.
of installation at all accounts by 3/31/06.

th a fax, e-mail and letter. The final step will be visiting the location to install the correct software.
to do regarding the corrections. Varian Medical Systems intends to release new, updated software.
ated 10/25/06.
tative would be visiting to make a short-term correction to the system. The letter also informed the cu
the devices once software is ready (estimated time for FD 10/10 is November 2006 and estimated time
a Siemens Service Engineer will visit affected sites to install this software patch which will resolve this
the software correction by a Service representative visit .
ated software version as soon as it is available.
8/05 that documented the information as provided by telephone. .
m parameters in the autoexec.bat file. The notification further recommended using the identified treatm
ExacTrac Robotics from the Exact Couch and re-calibrate the couch to restore the software limit switch.
y been installed on all of the units in order to correct the MPRs problem [Ref: RES #35081, Correction
cording to the firm''s Device Notification Letter issued on 2/21/2006, a second software upgrade [which
ternational units, but the firm has not received confirmation yet that these units have been corrected.
esentative if there are questions.
ermanent solution. Beginning on 2/8/2005, a second site visit was made to the same user/customers,
via email or fax on/about 01/13/2005.
software patch to resolve the issue, and hand deliver a Customer Advisory Notice, dated September 20
ed by Toshiba America Medical Systems Inc, for all affected devices. .
, via telephone on 7/6/2006. A follow-up letter dated 7/21/2006, was also sent to the customers.
upgrades by the service technicians began on 4/28/2006. The firm anticipates that the correction of al
y the firm.
n contact their local Toshiba Service person to schedule the software update.
tory Service Bulletin, No. 11, explaining the issues was shared with the accounts. .
tery packs will continue based on production capacity and material availability. Any patients expected
t a date for field servce to replace the power supply.
orm daily user tests and function checks while operating the defibrillator on battery power. In addition
ement indicators and Patient Management Considerations. ****** Prophylactic replacement of these d
ement indicators and Patient Management Considerations. ****** Prophylactic replacement of these d
ng term correction as a supplement to its 510 K which is pending review by FDA.
he problem and advising them that they will be visited and their units upgraded as replacement comp
s were requested to remove and replace the old batteries, part 520-LIBTA4-2, and compartment covers
w GMBH Service Center in Germany for repair (contact Ute Dieling at +49 (0) 7462-208-313).
mpleted work. A copy of each completed service record was sent to Ellex Medical Pty. Ltd. On 9/27/07
GENT DEVICE CORRECTION Letter stating that KION will visit consignees and replace batteries older th
mpleted work. A copy of each completed service record was sent to Ellex Medical Pty. Ltd. On 9/27/07
l users of the problem and advising them that their units will be corrected when replacement compone
ach unit will be tested with an oscilloscope device to determine whether it meets or fails design speci
ut-of-spec Well Leg Holder for a replacement.
ngthening previous warning by specifically mentioning the potential for over-delivery and severe hypo
otification to the user. The letter listed the error codes that may occur if the pump has been exposed t
es the issue, identifies patients with affected devices and provides recommendations.
m sent with the letter a new Quick Reference Card. Customers are instructed to replace the old Quick R
ed safe use of the device pending the correction.
06 explaining the reason for the recall and requesting the product be disposed.
s complaints are received. The firm modified its recall strategy and issued a Device Correction Letter da
s complaints are received. The firm modified its recall strategy and issued a Device Correction Letter da
perature Controller Board starting December 13, 2006.
up the device. If the 'ECG Comm' error occurs during use, cycling the power off-on may clear the erro
take if the system stops during an acquisition and displays the Collision Error message. They were told
oblem and advising them that their system will be corrected when replacement components become a
to manifest itself, and informed the firm would contact them to schedule an upgrade.
nterface board and remove resistor mounted on chassis, remove brake pedal and assembly of cosmet
ccurs and advised them they would be contacted to schedule replacement of the circuit boards.
equested to examine inventory, remove and return product.
visiting each customer site to inspect/update the units. Medtronic Service Technicians will complete a
ed for the correction.
ccurs and advised them they would be contacted to schedule replacement of the circuit boards.
defibrillating shock. The letter indicates the faulty AED10 devices were manufactured between 3/29/
erial numbers; (3)continuing use and safety information; and (4) contact information for requesting add
software upgrades. Installation of software upgrades began at customer locations on 10/16/06.
ifying all users of the problem and advising them that they will be visited and their units upgraded as
y first class mail.
the product notification was posted on the firm's internet website. Further, a flyer is to be included as
ions on how to avoid an event and correct an event should it occur.
repeat analysis.
been replaced. A safety alert letter was included outlining the failure indication and effect for the use
e, it can be restarted within about 1 minute by switching the system off and then on again, using the s
nd informed that one of the firm's field service representatives will visit the facility to make correction
e for an inspection and would modify their systems.
end-users are instructed to complete the notification survey and return the survey to the Mallinckrodt.
r will be performed at the consignee site. International consignees who require or request the repair b
ith a verified APB (351040-04 or 351040-05).
ve will be contacting the customers to arrange for replacement of the RAID component.
ctions to return the affected instruments for a full credit. The form included a reply form that consigne
on their systems were replaced.
g days by faxing or mailing an enclosed response. End users will be provided with a loaner device whil
mCornea Myopia and CustomCornea Myopia with Astigmatism of the device would be deactivated. Afte
nt units will be sent to them, and to request that they return the meter currently in their possession.
h a replacement Operator''s manual.
ring software and corrected manuals for distribution to address these issues. If customers have any qu
rrect the issue. An Acknowledgement form was attached to be filled by consignees as confirmation and
vice Rep. will be coming out and making a software upgrade to these systems within the next few wee
tinue use of 5.20.1038 software until updated 5.21.1039c software is installed.
ound instructions were sent on August 2, 2007 via certified mail. Customers were notified that Navisca
e to resolve these issues and that they would be contacted by Naviscan Customer Support to ensure t
nd future upgrade by wireless RF telemetry. .

. The problem will be explained to the consignee and they will be asked to return the pumps to Smiths
1-888-628-4159 or service@navsicanpet.com.
on. A Product Recall Notification and a Product Recall Bulletin will be sent to all consignees via the ma
software, and indicated that each consignee will be provided a user-installable software upgrade for th
nd notification was sent on October 31, 2006.
pon regulatory approval. The Advisory Letter provided short-term direction to reduce problems pendin
the company would be providing a software update that will rectify the issue specific to CIC Pro v4.1 s
pon regulatory approval. The Advisory Letter provided short-term direction to reduce problems pendin
In addition, product information letters are being packed with the instruments accessory kit and qual
ues with those displayed on bedside monitor. A temporary work around for this offset problem is to m
surements. Do not perform measurements on any zoomed batched images that have been stored on
surements. Do not perform measurements on any zoomed batched images that have been stored on
and promised new software updates to be installed by GE representatives, free of charge, beginning N
ftware upgrades, when approved will be made to devices.
ceipt, understanding and completion of correction letter. This is the short term fix pending software up
all ARCHITECT System Software v3.11 and were asked to respond via fax using Customer Reply form a
with laboratory staff and be retained as part of their Quality System documentation. A customer resp
er includes a Cover Letter, A Reply Form, and two Recall letters explaining the issue in detail.
r includes a Cover Letter, A Reply Form, and two Recall letters explaining the issue in detail.
mmendations and gave information on software update.
eplacement software, replacement instructions, and installation verification forms are included in their
rn receipts will be tracked. This is a short-term fix, a long term software fix will be issued shortly by the
never the monitor resets. The letter advises that consignees will be contacted to schedule an update,
y in order to upgrade the affected software. In the meantime, the letter recommends that the custome
s to upgrade their units. The firm later determined they sent letters out to consignees that did not hav
a radiation therapy simulation scan, they are advised to independently verify patient position prior to
acT/VIEW software version C.30b QTR 1 2007.
ed the VITROS 5,1 FS Chemistry Systems as well as the VITROS Chemistry Products THC (Cannabinoids
mailed to all international customers via register mail. Consignees are informed in the notification letter
reen condition. In addition, the letter advises that a representative from the firm will contact custome
o be erroneously copied during "Service Mode.".
7. The firm's Field Service Representatives will contact consignees to install the new software at no ch
e risk by disabling the auto transfer feature and manually transfering data until a software patch is ma
ection. The long-term correction will be software upgrade provided free of charge to all affected custo
that warning labels will be affixed to the units that alerts the user of the reconstruction offset defect
grade package. The software upgrade installation began at customers on 10/16/06, prior to issuance o
eloping software update to check for mismatch at the start of a subtracted fluoroscopy run, and will con
ersion 4.15 could be installed by a GE representative who would be contacting the customer.
n performed was left with each site after the upgrade has been completed. The firm's distributors rece
d from one plot to another, and then the new region is renamed, the statistics are not updated with the
to the Director of Pharmacy, Chief of Anesthesia, Director of Risk Management, and Director of Surger
them to schedule a software upgrade when software becomes available. If customers have any questio
esentative will perform the update.
mation regarding the recall on their website.
grade package. The software upgrade installation began at customers on 10/16/06, prior to issuance o
r 2007, will be available at no cost to the customer. The software will be installed by Philips Field Serv
em, safety instructions, product correction and contact information.
n tool to move the image left, right, up and down in order to display any portion of the image that may
software in the devices and if running FramelessArray version 1.0, to discontinue use of the software w
issions followed by all emissions until a corrective software patch is installed. The corrective software
problems noted in the Recall Notice.
hey could download the fixed software from the firm's internet website.
ed 01022006 was available to their customers on the firm's internet website.
issions followed by all emissions until a corrective software patch is installed. The corrective software
n April, 2004, to version 5.2.
ers by fax.
patch, titled 05312005 was available on the firm's internet website.
ed 04112005, was available to their customers on the firm's internet website.
patch, titled 04282005, was available on the firm's internet website.
ed 11302004, was available to their customers on the firm's internet website.
etails for user corrective action pending software upgrade by the manufacturer.
ed 12302004 was available to their customers on the firm's internet website.
Software version J.00.25 will correct the problem. Users are advised not to use th 12 Lead Analysis and
. The recalling firm plans to telephone the customers after the patch has been released to verify that i
ts a similar letter. When available, new software will be provided.
act information. Software upgrades were promised for correction.
s System. Once a solution is identified, a representative will contact consignees to arrange for installat
nges are to be made to the Caregroup Editor configuration on any system. If changes have already be
rt term workaround directions pending a free software undate promised in the near future.
n letter contains preventive measures.
ration Errors, stating that a Cardinal Health representative will upgrade the firmware on the devices at
customers have any questions they were instructed to contact their Toshiba Customer Service Engine
new software had been installed. All version 1.30 software was replaced and version 1.40 installed pr
ch site, to install a software patch beginning June, 2006.
oftware patch to correct the problem and will contact user regarding resolution. Users can contact Accu
mers were informed that a Toshiba Customer Service Engineer would contact them to schedule a softw
or's manual. A permanent software solution is under development and will be provided when it becom
er, since their unit was recently upgraded the problem did not impact their unit.
Software modifications installed by the recalling firm will follow as the long term correction.
ator, resulting in system damage. The customers were advised that a Siemens Customer Service Repr
the issue. In addition, the firm also stated that they are currently validating a new software modificat
ator, resulting in system damage. The customers were advised that a Siemens Customer Service Repr
ware release to correct the potential issue. A fax-back Acknowledgement of Receipt form was sent wit
ling firm's website on 9/28/07 for clients to download and validate. A Priority review Flash #PR07-0176
erform upgrade (software version 3.0.1) at user site.
Revision A is used. The customers were instructed to cease using the BrainSCAN or iPlan RT Dose soft
by an Abbott representative to schedule installation of software upgrade.
March 6, 2007.
pumps, identified by two attached hangtags entitled "Battery" and "Power On", from service. The acco
work around procedure to use until conversion back to version 1.06 could be scheduled. An additional c
Monday-Friday or visit www.physio-control-notices.com/coin battery.
61 for for assistance.
y should a component stop operating during a patient examination. Facilities should verify if their syst
t while the service is completed. Consignees with spectrophotometers having <15000 light source hou
and return the enclosed acknowledgement card to Stille by fax or e-mail as soon as possible and no lat
would be completed by the recalling firm service technicians.
s informing them of the problem and notified customers to replace the batteries. In addition, a letter wa
e recalling firm will schedule appointments with users to replace the affected part beginning in March 2
hrs mode. They were also instructed that if they have further distributed any of the recalled products
ecall. The letter requested users to complete and return an enclosed response sheet, indicating the nu
butors. The distributors will return any affected stock to Fisher & Paykel Healthcare, Inc. for document
he issue and what the customers are to do and includes a web site link for each specific problem. Each
ion daily. Service Centers were provided information to identify affected printed circuit board assembl
f the product remaining in date for use (not expired) had been implanted, therefore Medtronic provided
dical Device Correction Update" letter which informs the customer that this correction is a follow-up ac
008 and email between March 7 and March 13, 2008. The consignees will need to return the device to
age the device appropriately, insure it and return it via UPS using the provided UPS shipping label. Pro
Medical at 1-978-687-1501 for assistance.
remove the affected device(s)/spare parts from service and contact Baxter to arrange for their return a
arge or has an intermittent electrical contact. The accounts were requested to complete and return to
nsignees
were
notified
via email
on 4/24/08
informing
them of the
gnees were
asked
to confirm
completion
of the
cable exchange
bypotential
returningproblem.
an information card.
42-3100 or Toll Free: (USA): (800) 558-2345 or email info.pm@smiths-medical.com.
are estimated to begin on April 25, 2008.
ventual PCBA corrosion that could render the device inoperative and not ready for use in an emergency
(US), 608-273-5000 (OUS) or email shane.sawall@cardinalhealth.com.
lfunctioning occur. Datascope will be replacing the defective circuit boards in all affected IABP units. A
account to replace the cap per Update Instructions CT032/08/S.
te readings. A list of the affected sterilizer serial numbers is included with the letter. The letter advise
an "Acknowledgement of Market Withdrawal Notification" form for customer to complete and return to
oblem and also inform them that a Cardinal Health (Viasys) service representative will be contacting t
h account shortly after the sending of the letter to arrange for the installation of small fuses/circuit brea
e Representative will be in contact to schedule a service visit. For questions concerning this recall plea
9 IC, U9 IC, and the IUI, one letter for affected Ul9 IC and U9 IC customers, one letter for U19 IC-only cu
nitiated sending new adaptors separately, by mail, with a copy of the same Medical Device Correction
assembliesthat
andthe
to remove
and
quarantine
these
Any
installed affected
ommended
pump be
replaced
as soon
as parts.
possible
if ventilators
damage to with
the percutaneous
leadbattery
is confi
Users were also instructed to return any defective product to the recalling firm for a replacement. For
questions may contact the firm at 800-528-2577, or if calling outside the USA, 925-847-8600 (7 days
e. The notification advised that the safest way to mitigate the potential interference issue is to disable
m to revert to the central control module should these problems occur.
ptors. The current stock of product in inventory will be held under a stop shipment, pending destructio
MV exp high and Circuit leak alarms be set appropriately for each patient in order to detect a patient d
Affected transducers will be replaced. For assistance, contact Siemens Medical Solutions at 1-650-694
7. As the permanent fix users were informed the sensor will be replaced when replacements become
e firm recommended that the device should not be used with the firm's 340 Series telemetry system p
customers cease use of the video option of the device until the monitor can be replaced by VIASYS aut
on Technical Services at 1-800-707-0933.
ributors with this information being fed back to St. Jude Medical CRMD in Sylmar. In addition, St. Jude
arketed brand is the Deltec models 3000 and 3100. Smith Medical MD, Inc., included the 3M and Gras
t to do if the display goes blank while in use: 1.Continue to use the device to treat the patient. (voice
Data Aquisition System in September/October 2007.
ontact Terumo Cardiovascular Systems Corp at 1-800-521-2818 for assistance.
cked, as well as Reply Verification tracking forms.For further information, please contact firm at 508-65
ontact Terumo Cardiovascular Systems Corp at 1-800-521-2818 for assistance.
the need to return the system.
displays and error messages and if applicable act in accordance with the advisory statements and rem
nuals. A copy of the firm's corrections & removal report will be forwarded to Quality Management of Si
notice also provides temporary procedural instructions to include monitoring error log using System Ut
ou have questions.
. The firm plans on sending a Field Service Engineer to inspect the system and make any necessary c
nged to install the corrected License Key on all affected units of the product.
t ECG data. AGFA also informed their consignees that they would provide a configuration update to co
he flash memory and, 2) Perform a software reset of the handheld computer. A second notification add
fication as part of the Quality Systems documentation and return a response form acknowledging recei
d for all consignees. No other notification was made. The firm can be contacted at 650-694-5993.
e at their site. They were advised to distribute the information within their facility to all those who nee
on how to uninstall. For further assistance, please contact LifeScan Customer Service at 1-866-679-92
7.0.1. Users were also instructed to replace pages in the user's guide with the pages provided and to a
tallation until the date of system correction. The letter also instructed users that only images read wit
ing firm requested that all affected software be scrapped or returned to them. Users were requested u
nd will simultaneously update all systems. Philips has corrected the software defect and is in the proce
error message appears in the display panel, treatment should not be continued unless the photothera
new carotid measure package; 2) an Installation booklet detailing how to import the new carotid meas
vided corrective instructions and informed consignees that a product modification will be developed to
used for position correction. Consignees will be informed when a solution to this issue has been valida
k the "Filter Images on Loading" and "Saving of Filtered Images" config settings, and apply any addition
ded instructions for a workaround.
ction and is planned for release in June 2008. If you have any questions contact Roland Betz at (925)
equested that Baxter be contacted if an overfill should occur so Baxter can perform a complete investi
upgrade and, if so, they will help arrange for the upgrade. Please note that some devices may not be
stions or assistance.
crease the likelihood of a continuous reboot. If system continues to reboot, GE suggest that user cont
The letter also provided instructions for users to follow in order to avoid the software error before the
s to the user level and requested that the user perform the software upgrade, which will eliminate the
act the customer to upgrade their system. "In the interim, Philips recommends that you only use the H
users so that the units can be upgraded to enable the watch dog feature.
hort term recommendations. A long term solution is being worked on by GE and will be announced whe
ware (version 1.5.0c). Contact Siemens Medical Solutions USA, Inc. at 1-650-694-5993 for assistance.
d take until an updated software version was available. For assistance, contact Abbott at 1-877-4ABBO
The letter also included an attachment entitled "How to ensure a 'Connection to monitor lost' alarm on
be continued and measurements may be made safely in M-Mode by using HD-Zoom rather than pan-Z
amming Modules to correct an issue. The field upgrade should be made by February 16, 2007. A Dear
de,software
staff will
coordinate
to arrange
for service
abroad
confirm version.
the Auto Siemens
Analyze Setup
Option
is set towith
OFFforeign
or Afterdistributors
First Shock".
Instructions
for changing
r adjusting the lymph gate or attractors. The next software revision will alleviate this limitation.
g affected
one or no
fluorescence
parameters
will prevent
the
problem action
from occurring.
Customers are requeste
users,
with problem
description
and user
corrective
steps.
most recent FAQ, the PFILS Hotfix CD (PFIL67_66) and Installation Procedure for the PFILS Patch instru
e Service/Admin Tools. They were instructed to contact their IT department or Agfa support for assistan
Representative.
dated February 14, 2008, notifying them of the new update and making arrangements to install it.
pgrade for the products. Contact Abaxis Customer Service at 1-510-675-6500 for assistance.
l the upgraded software that corrected the problem. On 12/11/2007, the firm reported that the upgra
clicks above, or two clicks below the mid-point, and that there is a corresponding beep when you make
resentatives will be supplied with a fix to distribute to the user base.
nge will be tested for the software defect. If the defect is found, the circuit board that contains the defe
m fix will be updated to a permanent fix when a new software revision is released and installed at no co
, GE Field Engineer will visit each site to implement the correction. (Not conducted yet).
s for corrective software solution installation.
rder to prevent any adverse patient events. For example, if a lab result was entered as GFR <60, it sho
title bar, then they may interpret the current exam as a historical study and vice versa. The letter prov
ogic's Help Desk at 1-800-321-4659.
sers were requested to return a response form acknowledging receipt of the letter. For additional inform
a class II safety issue and that all customers need to have their software updated. The accounts were
ed that a GE Healthcare Field Engineer will schedule a field visit to install software updates.
re instructed to avoid increasing the SieClear compounding levels to an Advanced SieClear compound
enter at 800-722-9377, #5, #2.

mediately report this issue to your local GE Healthcare field service engineer.
so describes how the software upgrade will fix the problem and alerts hospitals that a Datascope Serv
did not inform the non-affected consignees of the failure because the firm concluded that the associa
ter settings. Upon completion of installation, a confirmation form will print out. Customers are request
ng inadvertent motion and serious injury may result and providing instructions on the recall. A new so
Group at 1-800-356-0007, 1-800-700-2282, 608-273-5000, or by e-mail at gsiservice@viasyshc.com or
". The letter was addressed to Healthcare Administrator/Risk manger, chief of Nursing and director of
tion letters were distributed starting January 03, 2008.
ontact Datax-Ohmeda, Inc., at 1-608-221-1551.
on of the field correction with the distributors for all countries. Consignees who do not respond to the
of the instructions for use in the file, and to notify all users of the issue with the software. The Sieme
install the software patch and requested return of the verification form. Contact Cardinal Health Neuro
download, or by sending a Field Service Engineer to the customer site to perform the upgrade. Until ne
orkaround should the issue occur prior to software revision.
e letter was also distributed to Varian Sites, Marketing and Service Organizations. A software upgrade
nder.vogel@siemens,com and make reference to complaint 08-1KM-0073 date 2008-03-06.
ue. The software will be released in August of 2008. Attached to the letter is an ISOLOC Device Corre
support at (866) 421-2536 or visit httv://www.mimvista.com/recall/ to obtain complete instructions reg
will be notified when the software is available for their unit. Customers are advised that the device is s
ding instructions on the recall. The recalling firm will arrange for installation of a software fix at each c
ior to Inferior direction, when using BrainwaveRT with 2D T1 weighted scan. A GE Field Engineer site v
the aorta analysis protocol or the customized protocols for an aneurysm until the new software version
he users were instructed not to make any clinical decisions based on a Card IQ Save State when a cus
patch ICC number 3618.
software patch can be issued. For assistance contact Philips at 1-877-328-2808.
software (iSite PACS v.3.5.69) on January 21, 2008. Firm is scheduling customers to upgrade to the cor
sent to consignees via certified mail with return receipt mailing to US consignees. For foreign consign
he users were instructed to refer to the image overlay for the correct date and time until the new softw
fix were promised in the Urgent Device Correction Notice. Updated information received October 4, 20
Advisory Notice, correct the problem and install a revised software version.
that those customers should refrain from using the DEVA with any combination of energies 5MeV and
and then 2.
upgrade had been performed at each site. New software level is A5.1 P2.
th each letter to ensure someone at the account acknowledges the information was received and unde
uct correction and contact information. FMI 60745 and 60746 was communicated directly to the GE He
ed accounts; Hospital Administrator, Manager of Radiology/Cardiology and Radiologist/ Cardiologist. A
the Medication Administration Record and Administration record. The correction will be in the form of
post processing application. A firm representative will visit each consignee to install the software upda
a GE Healthcare Field Engineer will schedule a visit to each facility to install a software modification.
be used until the software correction becomes available. The software correction will be released in Oc
ortance of always having backup equipment and instrumentation available when performing surgery w
USA) or send and email to customersupport@accuray.com.
GE developed a new software release that corrects this condition and will launch the corrective action t
sued to the field for the Precision 500D product to install a sofware upgrade to correct the issue. This
on how avoid the software error and informed users that their representative would contact them to s
Distribution of the product ceased on Nov. 2, 2007. Bio-Rad will provide Calibrator Set CDs with only
vided corrective instructions and informed consignees that a product modification will be developed to
will release a version of BD FACSDiva software to correct this problem. The letter also stated that BD Bi
are versions. After the planned field correction is performed at the customer site the Service personnel
contact them to schedule a software upgrade when the software becomes available. If customers have
erm workaround and informed them that a representative will schedule a visit to upgrade the software.
ent. A Service Representative will be scheduling a visit to user site to perform the modification reques
these messages if they are not. Siemens is preparing a modification under the UI IM086/08/S for the
update, and listed the steps to update the software. Customer notification was also issued. Software
allow the upgrade of the software upon logging in to the system. Contact Philips at 1-866-246-7316 for
can coincide with the internal auto zero function of the device. Under these circumstances a pressure s
tions to avoid the problem until the firm's representative is available to upgrade the software.
t with the prior software version, DICOMstore 2.04.34.02; and b) review patient ECG reports to determ
m the examination. The firm will issue a Field Change Order to their service representatives providing n
T upgraded
fields to ensure
thatisthey
matchCustomers
the RT Planwere
afterrequested
an Apply Limits
or Machine
Change
until
sof
software
released.
to complete
and return
theoccurs,
enclosed
Custo
44.
acquisition, you can avoid the problem by closing the single examinations daily or by clearing the pati
with Customer Care at Philips Healthcare Informatics, Inc. , please refer to this notification and associat
nce.
er reply form indicating that they received the letter, and were informed that they would be contacted
med they would be contacted by an Abbott representative to schedule installation of software upgrade.
surements. Phillips is currently investigating methods to correct this issue and will provide updates, fre
ule appointments to visit each site, in order to make the necessary modifications. The firm will be insta
oduct involved. The letter also informed customers they they will provide a free software patch within t
ed before opening and reporting on a second patient, and that a software patch will be available Spring
fied mail to all affected consignees.
orrecting this error. A field correction to update software is planned to be underway, designated to sta
a service pack is being created to correct the issue and that the recalling firm will notify users when it
022/08/S was released on July 11, 2008. A software fix is currently being validated. All consignees noti
users, and that the customer/user will be contacted for scheduling of a software upgrade by the distrib
ember 25, 2008.The letter requested de-installation of the software and return of the software to Holog
s to the user level and requested that the user perform the software upgrade, which will eliminate the
segregate the product in a secure area for Intuitive Surgical CSRs. If you have any questions contact K
de. Consignees are instructed to consult with their physicians or pathologist to determine specific clin
ware kit. For customer assistance, contact Boston Scientific at 1-508-652-5594.
its occurrence. In addition, the firm is developing a software update to correct the issue, which will be
unavailability of fluoroscopy and exposure can be avoided by not pressing the "Delete All Images" but
d provided instruction to avoid its occurrence. A software update (VB31E) was released to correct the i
961-3634.
letter describes the potential issue and mitigation. The recalling firm will also visit each site and make
e. The letter summarized the safety concern and the action taken. Any questions were directed to GE
the Freehand ROI feature until they are upgraded to a corrected software version. Philips will deliver a
. A representative will contact users to upgrade the application once the revised software has been va
recall CD-ROM containing the affected software and replace with the updated software.
is analyzer. The letter described a workaround and that a new revision of software, due out first quarte
work stations, via Product Safety Notification letter dated 8/29/08, sent via first class mail on 9/24/08
le , software version 2.0. Site visits will be made by Levitronix between Feb 2009 and April 2009 , softw
t 2008 that was f axed or e-mailed the same day. The letter repeated the information provided in the
affected cords exhibiting the described characteristics and contact their local Hospira representative f
replace affected cords and effectiveness checks will be conducted through tracking of servicing.
g will notify your customers of the recall directly.
ical Services by calling at 1-800-707-0933.
mation, consignees were instructed to contact SeQual Technical Support at 1-800-826-4610 from 8:00 A
completed AN Account Summary of the Flexiflo Quantum Enteral Pump Shipments. AN Device Call Ce
ecord the number of affected packs on the attached business reply cards, and return the card along w
t 1-800-638-2546.
Service at 1-800-345-6443.
act your local GE Healthcare field service Representative if you have any questions or concerns regard
shing information of the notification on industry magazines. http://www.zollaedplusbatteryhelp.com/.
o verify that back-up pumps are available; and provided steps for addressing an interruption of therapy
e at 1-877-441-7440.
e event of this failure, unheated tap water will continue to flow through the device back to the water d
espironics.com or clinical@respironics.com.
er. The letter described the Safety Issue, Affected Product Details, Safety Instructions (included "Recall
0-4236 extension 4086.
ructed to respond to the letter by calling 888-345-5356, and decide on replacement or discounted new
d to complete the "Device Correction -- Customer Fax Response" form and return via fax (732-667-1903
0-551-5544 ext. 41835.
e at 1-877-600-7555.
ssues. All warmers in the field will be replaced beginning in May 2009.
aging and returning of the unit(s) for repair. The customer is also instructed to complete the attached R
further information. No return reply was requested.
d the potential risk. For additional information, contact ZOLL Lifecor Corporation at 1.800.543.3267.
-227-3422.
ystems beginning in Feb. 2008 or that parts would be shipped to consignees wishing to perform the wo
omers were instructed to complete and fax the Customer Response Form to CVS Customer Service at 1
0.345.6443, Option #5 then Option #1.
58-7044, enter Option 2 and ask for Technical Support or your local GE Field Service Representative.
Healthcare Diagnostics Inc. directly at 1-973-927-2828.
1-800-888-7436 (USA).
ital. This letter was directed to the EP Catheter Lab Manager with a cc to the Hospital Risk Manager, H
tions for safe use of the affected systems.
firm visited each account and made corrections.
561-627-1080.
mendations to physicians. The Performance Notes will also be posted on the firm's website. Direct que
ructions to customers, and the firm_x0019_s strategy to fix the affected devices can be found at: www
1-800-442-1142.
Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. The se
Distributors, Clinicians and other Customers. The letter listed the Details of Affected Devices, Descripti
at the product should be returned. For additional information, contact St Jude Medical at 800-722-342
st will be made, or as an alternative, the third contact may be by phone, e-mail, or fax. Affected produc
.
nts at 1-800-441-4100.
the software upgrade kit for installation and instructions.
acement of the therapy switch in the affected devices.
ker Instruments Regulatory Department. For questions regarding the recalled product, please contact
District Manager.
ation or support concerning this issue, please contact Philips representative at 1-800-722-9377.
contact your local GE Healthcare field service representative.
tinue to use the Infinia Hawkeye system normally for all types of Hybrid scans and stated that as a gen
at have the hardware and software enhancements and meet all performance requirements in full.
priate configuration option and implementation. The notification letters included with this report packa
epartment per their facility's protocol. Units that operate as expected can remain in service and backure the Auto Collimator Change check box on the Camera Parameters Tab is not checked. They also w
00-437-1171.
ed to users in case they encounter this failure mode. ABIOMED Field Service Engineers will contact cus
edgement form and return it to your Clinical Technical Specialist (CTS) or in the enclosed pre-paid addre
ive measures for consignees. Monitoring will be done via return cards. Follow-up to be conducted via
e controlled by a software license key, iCAD will disable these features by updating the license at the aff
were sent to all users of the affected systems. Philips will modify the system software and will be inst
Medical Device Recall letter to distributors and customers on February 26, 2009.
ion sheet was not received by end of day, December 9, 2008, the letter was mailed to the physician o
has been reset and Cyberonics should be contacted for any additional instruction.
has been reset and Cyberonics should be contacted for any additional instruction.
een advised of a workaround. In the notice letter, Agfa HealthCare is also providing customers with the
2.
on for reporting any adverse reactions experienced with the use of the affected product and/or quality
rs explain the issue. The patient letter is accompanied with a CD that contains the upgraded software a
e Confirmation Form can be faxed to 1-800-628-6322 in the U.S. or 1-651-628-7485 outside the U.S., co
t Center by calling 1-800-558-7044 (Option 2, Technical Support).
on who has the AED in their possession. A separate letter is being sent to distributors. The letter advi
ing developed concurrently with the notification. The firm will mail or hand-deliver the notifications v
ded to version 4.B.1.4 software, provided the instruments have a 486 Motherboard or Single Board Com
722-9377.
3-5047, extension 1-2349.
1-3111 or +1-714-427-5811 Extension 500.
sk Manger. The letter described the problem, product and provided recommendation.
duct details, safety instructions, product correction and contact information. Direct questions to GE He
any questions.
return to Hologic the enclosed Confirmation of Notification.
organizations, informing them of the issue. The firm intends to produce a software fix for the problem.
edical field service representative would contact them to perform software upgrades on the affected b
edical field service representative would contact them to perform software upgrades on the affected b
am at 1-888-275-5286.
ustomer Care Center at 1-800-437-1171.
Care Center at 1-800-437-1171.

notice, and confirm receipt of the communication by completing the attached Customer Response For
carryover specification provided in all applications of the manual. Questions from customers in the US
uary 6, 2006 to explain a software update.
with safety instructions to follow until the software is updated. Any questions were directed to the Rem
r information regarding this recall. Further information can be found by calling 1-800-437-1171 in the U
kstation. The letter provided the users with safety instructions to follow until the software is updated. A
iagnostic Ultrasound Systems that were distributed.
. A telephone contact number for Technical Support was provided in the letter. A permanent software
Canada. Outside the US and Canada, they were to contact their local Beckman Coulter Representativ
erize the use of the Live Gate feature. The letter provides the customer with explanation of Live Gate a
Fluorostar 7900 has received the corrective software installed, they are encouraging facilities to exerci
7-1171.
rective action steps. The letter was also distributed to Varian Sales, Marketing and Service organizatio
id its occurrence. A software update to correct the issue is currently being developed and will be insta
the issue and to install a software upgrade that will correct the handpiece recognition issue on the con
follow until the software is updated. Please direct any questions to the Remote Online Center, Field En
oducts, safety Issue, short term recommendations, long term solution and contact Information. The fir
vices. The letter instructed to collect and hold all non-implanted Maximo II devices and that a Medtron
or support concerning this issue, please contact your local Philips representative: Customer Care Cente
contact your local hematology customer support representative.
n." The firm also highly recommends for customers "to check the correct display of "left", "anterior" an
1-800-722-9377.
our local GE Healthcare Service Representative.
boratories Customer Support by calling 1-877-422-2688. Customers outside the US, please contact yo
ne at 1-800-736-0600 opt.
e will be upgraded to a current software revision. A Datascope Service Representative will contact cus
til a new version of AMPLILINK software is available and filing the letter for future reference. Questions
rth America).
1-800-727-4102. If you have any questions regarding this issue, please contact your local field support
orrect it. A revised software version will be provided to the customers. Any questions should be direct
fication on their systems that limits the field size to a maximum of 4x4 cm2 when the conical collimato
potential issues associated with the device. Contact 3M IMTEC Technical Support at 1.800.879.9799, if
Care Center at 1-800-437-1171.
d provides instruction to avoid its occurrence. For additional information, contact Siemens Medical Sol
d the users with safety instructions to follow until the software is updated. Any questions were directed
Radiologists. The letter listed the Safety Issue, Affected Product, Safety Instructions, Corrective Action
ministration record (MAR) and the administration record in determining the care their patients receive in
ilips is currently developing a correction that will be available at no additional charge. A Philips repres
88- 827-4265). In Europe, contact +41 41 749 8844.
line, reimbursement, and reporting. The firm is preparing a software upgrade for the affected products
e. A software service update to solve this issue is expected to be released by August 15, 2009. A Mand
o patients. Stryker will not bill customers for the Guardian service until the problem is remediated and
ogy, and Radiologists. The letter listed the Safety Issue, Affected Product, Safety Instructions, and Con
n of landmarks has begun, and the issued will be fixed with the next software release.
63-6649.
tomers to complete the actions listed in the letter to install the Field Correction and return the complet
6-4700 (outside US) or customersupport@accuray.com.
backup storage for the NetPractice are included with the letter. Stryker will not bill customers for the G
08/S has been performed. The addendum informs the user about safety relevant notes which pertain to
m Accuracy, and deliver the Customer Letter notification. Confirmation of the visit was documented.
mentation of this upgrade. Please contact the Philips Customer Care Center with questions or concerns
925-602-8157.
e on all affected systems beginning in June, 2009, and that a Hitachi Service Rep. will be contacting ea
GENT -Medical Device Correction" report dated January 29, 2009 which contained information noted in
entative will contact each customer to schedule a software upgrade. For further information, please co
ders. When the new hardware/software solution is available, affected devices will be updated free of c
he firm is planning a field correction expected to be available in "Q1 2009". For additional information
uded their syngo RT Therapist Express manual and remain there until the next release of software is in
rformed on request by the customer service group. Further questions regarding this issue are directed
ed that a software patch has been prepared to resolve the issues and will be installed on their system.
physician review. The letter provided the users with safety instructions to follow until the software is u
d how the issue will be resolved. Customers are to ensure that the Safety Advisory is placed in the sys
tact the Neusoft Medical Systems Service Support Department (helpdesk@pnms.neusoft.com) or conta
514-931-6222.
s occurrence. A software update to correct this issue is currently being developed and will be installed
rvice representative.
by letter dated February 9, 2009. Direct questions to Xoran Technologies at 1-800-709-6726.
de. Notification will also be sent to the international consignees by Philips personnel. For further infor
5171 extension 405.
10-7100.
this recall notification letter. They were then told to refer to the enclosed Recall Questionnaire for instr
states that the firm will be installing updated software on all affected systems beginning in June, 2008,
ce was sent via FED-EX on/about 12/24/2008 to all sites. The letter describes the potential issue and bo
ages from microscopic slides of breast cancer specimens stained for the presence of estrogen (ER) nuc
ware on all 5 units.
1-800-786-0239.
USA) or 1-408-716-4700 (outside of USA) or customersupport@accuray.com.
ue and provides instructions to avoid its occurrence. Questions regarding this issue are directed to the
eps. The letter will be distributed to the sales, marketing and service organizations via certified mail.
ructions to customers, and the firm_x0019_s strategy to fix the affected devices can be found at: www
tware version 2.02 and lower to version 2.06.02 by Proc. AED10 Prod Service Min HW/SW Update Rev. E
version 2.06.00 and up indicates that all returning AED 10 units shall have their software version down
mediately quarantine any affected product and label as recalled product; complete and sign the enclose
n the plug are not affected. Urgent Medical Device Correction letters were sent to Distributors describin
before scheduling a device .
nds physicians continue to use the ERI notification to determine time for device replacement. At this tim
Battery (Product #M3538A) Number M3538A in the the Philips HeartStart MRx Monitor/Defibrillator. Sh
ou have read and understood the Safety Alert Letter. If further information is needed, customers in the
United
Statesidentified
can call 1-425-657-7200
for any
about
recall.
. The letters
the product, thex5089
problems,
andquestions
the action
to bethe
taken
by the customer.
mpt, 2 at the second prompt and then 32349#).
-step
on performing
the repairs.
with questions
the videotodemonst
g the instructions
affected product.
If they distributed
theAccounts
affected product
further,after
theyviewing
were instructed
sub-rec
ityto
Assurance
Department
1.847.855.6304,
or e-mail
to: Requested consignees to fill out the
ed
discontinue
use of theat
AC(fax)
power
cords and to destroy
them.
0.
with non-retractable cords by Medtronic, beginning on Aug 17. Further information is available from the
or, Product complaints & Field Support by phone 610-448-4634 or email: josephine.mcbride@siemens.
ions for
customers
to take.
port,
about
this correction.
d October
23,dated
20093/25/10
to their consignees.
Notice
letters
issued
via regular mail
on 3/26/10
and and
alsosteps
providing
thefor
reason
for rt
ation instructed
Consignees were
on proper
identification
of affected
product
to take
product
ed "Advice on Action to be Taken by the User". Consignees were requested to complete and return the
0-19.
The consignees
are informed
that there is a
877) 856-3546
if they had
any questions.
otify them at once of this product recall. Their notification to their customers may be enhanced by inclu
387-3311.
blank. Audio alarms will continue to function normally.
7-453-4507
or 1-203-453-4507,
8:30
AM toinstructed
5:00 PM Monday
Friday,and
EST.to forward notification of the re
the case, not
to remove batteries
unless
to do by- APOC
ward
in Phase
2. ET1920L-7SKR-1-35S-SPC
Customers
advised
toreplacement
keep
defibrillators
in customer
service,
and
to be
follow
recommende
mer
should
contact
Philips to are
arrange
for a
device.
The
should
also
run
battery
th part
number
are
notthe
part
of
this recall
and
should
not
sent
in a
for
upgra
about
this
action.
or
servicing.
The
second
letter
reiterated
that
Medtronic
would
notify
customers
when
FDA
approves
th
essary to prevent any failure to monitor.
option
6.
k to help prevent an adverse event from happening.
1991 concerning this action.
0. precautions
ded
at free of charge.
ng
1) if using AED, have a back up AED; 2) if using external defibrillator paddles, disregard
ons,customer
call Ryanwithin
Rea or30
Kevin
at 866-815-6999.
ach
daysRea,
to arrange
an update to affected devices.
cal Support . Consignees outside the United States may call 1-425-657-7200 x 5089.
nd to continue to perform daily User Test.
es additional information on the implemented resolutions. For additional information, please contact th
unanticipated disruption in their use of their product;
al customers) to request the replacement kits you will need; and

, problem and advised consignees to remove the affected product from inventory and promptly return
ensure that all affected ventilators have been addressed and close this field action.
tributors via phone and email on 11/2/09 and by letter on 11/9/09. A web site providing information re
mpt return and replacement of any the patient circuits in your inventory.
for US customers, 714.427.5811x500 for international customers).
e Bulletin (TSB). The TSB requires inspection, testing, and potential replacement of the affected assem
tter detailed the method for identifying SID failure and the use of the emergency back-out buttoms to r
dEx. Consignees are provided with a response form, and are instructed to run a software correction.
uestions or concern about this recall.
45 6443, option #5, then option #1.
his recall.
, #3, #1 and reference FCO 99862012.
3.
l Engineering. Customers will be required to confirm receipt of the notification by returning the Recall R
ollow prompts). A service representative will visit each consignee and conduct a software and hardwar
0rch
with
relating
to thisThe
recall.
24,questions
2010 to all
customers.
letter describes the issue, impact, action and resolution.
defective units (those within the date range of September 1, 2008 to December 30, 2008). Customer
y-stepcorrected.
description
of the will
issue
andrework
the required
for users.
evice
Cardiac
send
kits noactions
later than
June 30, 2010. CSC can be contacted at 44
at 1-610-448-3237.
k of generating erroneous results:
52.
yed by Philips.
2-9377, # 5 and reference FCO 72200144 or FCO 70800091 with any questions.
Endura
letters to their
customers.
ed
,Engineers,
skipR2.2
the remainder
of
section
and
proceed
the option
Resolution
section;
please
contact
the
firm awaiting
at
1.800.426.0337,
1.
sice
instructions
on
actions
to this
take
while
their to
replacement
speaker
assemblies. The speaker rep
esthesia,
Health
Care
Administrator/Risk
Manager,
Director
of
Biomedical/Clinical
ts. the
CareFusion
does
not
require
that
you
return
your
devices. Insection;
the interim, if youEngineering.
observe this issue, r
kip
remainder
of
this
section
and
proceed
to
the
Resolution
AED155@cardiacscience.
com.
checks for the
of the "Speaker
Malfunct." INOP at power-up.
presentatives
indisplay
each affected
geography.
Correction
and
Contact
Information.
ntract,
the visits
would
occur
at
the next
scheduled
maintenance visit. Customers withou
enada,
will replace
the
stand-trolley
cable
free of
charge. preventative
contact
their
local
Beckman
Coulter
Representative
and
follow
the instructions
below until the so
emove the device from use and contact your local Philips service representative
at 1-800-722-9377.
21-2818.
blems
should
also be
d Uptake,
or Total
T4 reported
samples;to the FDA's MedWatch Program.
of
the
Urgent
Medical
Device software.
Recall Notification.
vised labeling and calibration
The new meters will indicate that meter recalibration is required
"FCO
71800024"
with
any
questions.
ng
the affected
product,
the issue
prompting
Access
Testosterone,
Thyroid
Uptake,
or Totalthe
T4;recall, and actions to be taken by consignees.
Philips
at
1-800-722-9377.
nfirm their receipt of the notice, to indicate the number of kits discarded from their inventory and the p
Advocacy
and Technical
Support
000-CC012084,
and
the
Part Number
0570-0168.
lowrecommended
Access
Testosterone,
Thyroid
Uptake,
or Totalcan
T4
results
fromback
samples
tested
in conjunction
nted
and
actions
tounits.
take.
Theifgenerator
be
reprogrammed
the physician
the
nextw
omally
Smiths
Medical
to
be
inspected,
repaired,
necessary,
and
returned
toby
medical
facility.
A Confir
ack-up cylinders and depressurization of the regulator when not in use. The replacement plan for all IN
25-867-1348
800-2331-2313 or send e-mail to cservice@verathon.com.
he
instructionsorprovided.
certified mail (domestic) and FedEx (international).

, test ID 275)
must
be recalibrated.
Recalibrate of the Access Testosterone, T.
Customer
Service
Department
at 1~866-270-7060.
ence,
Patient
management,
Devices
Affected and Further Information. Patients were also sent a Boston
ormation on their website.
inical Technical Support at 866-882-8804.
ty Issues, Affected Product Details, Product Correction, Safety Instructions and Contact Information. "A
er Service Department at 1866-216-8806.
For questions, please contact the firm's Cardiac Science Support at 1.888.402.2484 or. AED195@cardia
s informing them of the monitor failure and that a field service engineer will contact the customer to fi
800-810-8188; for other countries, please contact your local GE Healthcare Services Representative.
he Safety Issues, Affected Product Details, Product Correction, Safety Instructions and Contact Informa
ions regarding this recall or 425-487-7469.
Service at 1-877-870-5610.
31.
8-8667 (USA), +1-408-716-4700 (non-USA) or email: customersupport@accuray.com.
elevant safety precautions are observed and check their operators console (EEC) if the labeling is pres
on into the product Use and Care manual for operator warning. Consignees were asked to complete a F
ed through TAMS' representatives. Reimbursement for the modification will be given upon receipt of th
-9725.
orking solution, and requested action. Clients were instructed to acknowledge receipt of the notificatio
ns should be directed to Abbott Point of Care Technical Support at 1-800-366-8010, Option 1.

ues and has not stopped. Additional notification was issued in 09/2010. A software correction is plann
5, 6:00 am to 4:00 pm (Pacific), Monday-Friday.
ales Representative or Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8.
med Field Service at 1-800-554-8666.
e or call 1-800-526-7694.
dical will be reworked with the software upgrade and place back into distribution. Consignees will eith
all the patch on their customers devices immediately. Field correction was completed 7/31/2007.
nternational), if they have inquiries concerning this advisory.
he software version they are using. They are advised to contact SonoSite at 877-657-8118 to obtain a
e or call 1-800-526-7694.
y utilize the pump and the software. As a courtesy a letter dated 12/22/09 was issued to the health ca
ntact Varian at +41 41 749 8844.
0-724-7000.
e or Medtronic Technical Services at 800-723-4636.
ade approximately four to six weeks after the second mailing or as an alternative, they may be contac
the device correction needed. The effectiveness of the correction has been tracked via acknowledgem
dulation Technical Services at 1-800-707-0933.
or via email at susan.niesen@carefusion.com.
Test Form 4. If unable or unwilling to perform the software upgrade they provided information for retur
rt at 508-359-3877.
rrection.
on step. The firm is in the process of preparing a software fix for the issue.
ees to follow specific detailed instructions for safe use of the device pending provision of a software up
-437-1171.
products and providing instructions on the recall.
48.
t 1 800 333-8828.
t this issue.
n. Questions or concerns are to be directed to the GEHC OEC service team at 1-800-874-7378.
-800-348-9011 or 1-978-421-9460.
(972) 410-7319 or via email at StrykerCommunicationsRA@stryker.com.
or via email at crossfireconsole@stryker.com.
hnical Support at 1-800-558-7044, or your local service representative.
and modify site configuration or upgrade existing software to the version containing the corrective fix.
Customer Care Center at 800-437-1171.
tion and a risk summary and the support. The upgrades were to be handled through the local represen
Technical Support or your local GE Field Service Representative.
41.
t at 1-800-854-3633.
or e-mail to service@sonosite.com for any questions regarding the recall.
ence "FC0 70600030" with any communication.
n.com.
a software upgrade and will be performed by Philips service personnel. Contact Philips Customer Care C
eded to install this software update can also be directed to Customer Support.
service engineer will make a schedule a mutually agreeable time with the consignees to update the IC
event locking of the RBS server. A software upgrade with corrective patch will be delivered electronical
ViewGT R3.4 Service Pack 2 (SP2) installation CD". Mandatory Field Change Order 764 00 551 059 "Re
problem. The consignees may contact the Philips Call Center at 1-800-772-9377, #5 #2 and reference
tch to re-establish the correct parameters on the LLS board. Direct questions to Abbott Laboratories, I
the Patient Portfolio Sidebar before saving t he voice clip in the Patient Portfolio Sidebar, McKesson reco
inical inquiries about this recall.
ovided recommendation to their customers. Questions or comments are directed to the firm's Custome
the Safety Issue, Affected Product Details, Product Correction and Contact Information.
ext. 4235.
57-7200 x5089 for technical support or questions regarding the recall.
-0120-055-919. For other countries, please contact your local GE Healthcare Service Representative.
espresentative at.
bernet will start the RMA process for returning the devices for the updates, free of cost.
1. Additional questions are directed to the firm to Product Manager lrobert.aslund AT elekta.com, or Aft
and validation of the correct patch.
d reference FCO 72200111 or FCO 72200125.
3-336-7255.
0C to V2.0B.
.
Clients were instructed to acknowledge receipt of the notification. If the client wishes to receive the
company is directing questions to the local Electa representative or to their offices in the U.K. at teleph
ntact Medtronic Patient Services at 1-800-268-5346.
100.
such so that Global variable is not used. Clients are asked to acknowledge receipt of this task and upd
e clinical impact, and the work around. Although not stated in the Safety Notice, a self-addressed post
.
ustomer Care Center at 800-437-1171.
tion Center. The firm can be contacted at 608-824-2800.
d reference FCO 72200111 or FCO 72200125.
-777-0202 and ask to speak to your support Manager.
023.
condition. Use of the product should be discontinued until the update described in the letter is perform
2000031 for any questions or support concerning the recall.
e firm at (714) 730-5000.
ers provided the users with specific safety instructions to follow until the software is updated. The custo
961-3634.
eld correction to provide a software upgrade to the DRAD-3000E; Radrex-I, Electrostatic x-ray imaging s
oblem and to cease use of the software for diagnosis.
nms.neusoft.com regarding the recall.
mpac.com or call their support center.
-9725.
are Center at 1-800-722-9377.
erence FCO 83000129 for any questions.

mers are to notify their FHC representative to confirm receipt of the notification. A software patch has
Issue, Product Affected, Recommendation Actions and Resolution. The issue will be remedied by softw
1.0.3. The correction would be free of charge and the consignees should contact Philips Call Center at
me Service Center (michael.mib.braun@siemens.com).
0100.
test release of version 3.17.7 or 3.17.8. Clients were asked to acknowledge receipt of this Task and ind
ens Service Reps will contact the consignees in a timely manner to check if there are symptoms for the
or the Result Reporting interface. If this function was turned on at the time of creating the canned me
imen Registration - Standard Settings - Minimum Time to Reactivate Case Number" should be set to "
er door closure procedure to help prevent the potential bypass issue from occurring. Attached to the l
od. Although Edwards does not believe there is a need to stop using the Aquarius system at this time,
alls and were provided with a Battery Maintenance program. For further questions you may call (408)
gizer C size batteries may also be incorporated by other battery manufacturers. The accounts were req
0.
6:00 A.M. to 4:00 P.M. (Pacific), Monday - Friday.
800-793-9227.
l soon to be released. A Caution label with installation instructions was included with the letter, to be
46-8407.
ere unable to perform the inspection or had questions concerning the instructions, they were to contac
mber 2011 was left behind at locations in which the MDT representative swapped out the devices.
ll. Information on the recall was posted on Medela's website www.medelareturns.com on January 11,
ide the U.S., please contact your local hematology customer support representative.
thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charg
nic Technical Services at 800-505-4636.
p cleaning process). If the alarm is not audible, they were instructed to discontinue use of the pump an
g a copy by return mail to the address indicated on the Customer Response Card, (Attachment A-2).
142, Option 5.
9-7373 or (513) 772-8810.
l 1-425-657-7200 x5089 for any questions about this recall.
n.com; South East Asia: seasia.apps.helpdes@varian.com; China/Asia: china.apps.helpdesk@varian.com
ns were directed to Health O Meter Professional at 800-815-6615 or 708-377-0600.
0800114, 70800115, 72200184, and 72200185.
product.. They were to review their inventory and return a Business Reply Form via fax to 303-699-98
nt further use. If there is a clinical need to continue use of the lift before it is retrofitted or replaced, sp
omer Service at 1-800-521-2818.
nt product in quantities equal to the returned product. The attached form should be completed and ret
58.
18.
969-0750, 8:30 am to 5:00 pm EST.
administrator at 1-800-989-7373.
Customer Response Form was attached to the letter for customers to complete and return. Terumo C
at (877) 937-7867.
sionice.com for any questions about this recall.
00-526-7694 in the United States and Canada or contact their local Beckman Coulter Representative.
, between the hours of 8:30 A.M. and 4:00 P.M. Pacific Time.
r at 1-888-627-8383.
been serviced, nor does it apply to MLX units that were serviced outside of this specific timeframe. C
f the letter and form for your records. For any additional information please call 609-936-2485.
tential risks for misdiagnosis. The firm planned to exchange the faulty hardware component in the sys
delivery of energy, and to contact AngioDynamics Customer Service at 1-800-772-6446 if shortened
86-4107); Product Manager (Tokyo) 03-6255-5740, and/or your SJM sales representative.
604, and /or Sr. Director, Customer Support at 954-927-2044 ext. 442.
t, Quality, GIS at 847-270-5507.
9837 during the hours of 8:00 am to 5:00 pm Central Time.
notification/alert procedure appropriate to your .
377 # 3, # 1 and reference the letter or your local Philips representative in your area.
7 if further information or support is required.
dance with the Operator's Manual and previously supplied instructions until the inspection and necessa
m. The defective speakers will be returned to vendor (Beach Wire) to be discarded. This correction wil
tion from occurring. The checks ensure that the PIC 50 and its component (including the screen displa
nd the actions planned by the Philips Invivo were explained. Users were to follow the instructions prov
malfunction
as prompt,
it occurs,then
and2,
thus
timely
maintenance and repair".
press 1 at the
then
32349).
ted facilities by certified mail on April 5, 2011.
eturn product and order replacement product, consignees were instructed to contact the Smith & Neph
114.
ee devices
were further distributed.
call 1.866.484.3268.
rrection is available to schedule installation on your system. Questions regarding the letter should be d
e at 1-877-266-4543.
formation sections.
dress, serial number and part number to WA2221@Stericycle.com.
OULTER
HmX ifHematology
Analyzer
with
Autoloader,
COULTERshould
MAXM contact
Analyzer,
COULTER
Hemato
front cover,
additional stickers
are
needed,
the customers
Terumo
CVSMAXM
Customer
Ser
nd
the
original
discarded.
If
the
control
materials,
discs
or
value
sheets
have
been
forwarded
to
anothe
the
following
mitigation
options
works
best
for
their
institution.
Both
options
will
have
the
same
effect
front cover, if additional stickers are needed, the customers should contact Terumo CVS Customer Ser
ate
to to
thecomplete
safety instructions
ucted
and return and
the product
enclosedcorrection.
PCA Response Form within 10 days.
pport.
For
outside
the
US,
customers
can
call
1-425-657-7200, x5089.
fax 2011
to 781-861-4207
or customers.
e-mail to ra-usa@ilww.com.
0Product
Alert@welchallyn.com
uly
to all affected
diation
Physicists
/
Dosimetrists
/
Therapists.
The letter described the Safety Issue, Affected Product D
3633 in the United States and Canada or www.beckmancoulter.com/customersupport/supportrequests.
h any questions.
l one of the
526-7694
in theThe
United
States
or Canada,
or contact
localProduct
Beckman
Coulter
representative.
al
Engineering.
letter
described
the Safety
Issue, their
Affected
Details,
Product
Correction, Safe
fied
the
product
,
the
problem
and
the
action
needed
to
be
taken
by
the
customer.
normal
business
hours.
Service Engineer will contact them to check, and if necessary make adjustments.
h any questions regarding this medical device.
he letter identifed the product, the problem and the action needed to be taken by the customer.
122.
tive will
contact
to arrange for thisextension
correction.
utside
the
U.S. atyou
+86512-8717-1888,
304.
mation
Certificate
and
return to Medtronic
per thewon't
instructions
onthe
thePrismaflex
form. TheOperators
letter states that if the
ed
Chapter
5: Troubleshooting,
"Softkeys
work."
of
m.copy
Theof
letter
identifies
the product, problem,
and actions
to be
taken
by the customers. Manual in co
e Representative.
not to mix
treatment plan information from multiple planning systems. Customers were aske
nadvised
for all affected
units.
t, and the workaround. The notice stated the sites will be notified when a solution is available.
of the following phone numbers:
0.
epartment
began
contacting
by telephone
onreceive
Januarya13,
2011, to software
scheduleupdate
an appointme
setting. Abbott
informed
the consignees
customers that
they would
mandatory
and we
uestions:
Gambro
Customer
Support
800-525-2623,
option
2
(Available
6:00am
to
5:30pm
MT,
Monday
rections in attachment A. Additionally, customers are to complete and return an attached form to AMO
2.
. Confirm receipt of this and to fax back the Customer Response form.
a displayed value is significantly different from expectations based on the clinical situation, the user sh
ers dated July 20, 2011 to all affected customers.
nd Regulatory Affairs Abbott Hematology at 408-567-3403.
esproduct,
the problem, and the action to be taken by the customer.
notice. section
nt
of the
appropriate
edNotice
users, beginning
June
30, 2011. User Manual; to complete a FlexMap Check each time they acquire
,ctions
Monday
Friday,
8
AM
6 PM EST.
have
been indicated:
product,
customers
were
instructed to stop using it and remove it from their inventory.
ealso
Representative.
asked customers to notify appropriate personal provided instructions.
ated
October
2005)
was sent and
to Elekta
Service
Engineers
asthe
notification
ed
the
product,
the
problem,
the action
to be
takenorby
customer.of the problem. The letters de
(732-635-0144)
or e-mail
(techsupport@itcmed.com)
mail
to:
ns to ensure data is stored in the system.
charge
to issue
customers.
GEcorrective
asked customers
post the notification letter on the affected equipment un
are
of the
until the
action isto
completed.
RIAN5 (888- 827-4265).
2.
157.
he notice advise all customers to follow any instructions or recommendations covered in the Notice. F
ory software update will also be conducted.
) or 732-548-5700 (International), ext 4707.
mation of Receipt Form by one of the three ways indicated. The letter instructs consignees to distribut
mers site to arrange for a patient matching criteria audit to determine if you have a problem. Custome
cted systems will be updated with aforementioned kits in six months after the release.
and explanations to the XiO On-Line Help. Your site will be notified when this release is available."
o nms-service@neusoft.com.
08-830-8023.
nd understood. Agfa has discussed with the customer how the de-installation of their CRS Remote prod
splayed on the Cockpit screen (or any other change to the auto display screen layout).
d their customers to notify them of the problem.
7.
inform users of the mandatory upgrade and related information. For future reference, this document
3.
-526-1247; for Research customers, please contact Roche Applied Sciences Technical Service at 1-8003.
Philips representative at +1-877-328-2808.
5398.
at a software upgrade to address the issue is currently being developed. Customers were instructed to
ntries. The software anomaly has been corrected in software version 7.3. Draeger Service Representa
nical Product Support at 1-800-627-7867 (800-627-PUMP).
7503/7504; mail to Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 310B06, 11.
ed to make the appropriate configuration change, within current software versions 7.1.4 or later. Conta
am-5 pm PST. Customer can also send an email to Technical Support at service@sonosite.com.
ent to Varian Sales, Marketing and Service organizations to inform them of the recall.
chnical Support at 1-800-558-7044, or your local Service Representative.
m to the PC will correct the issue present in certain images sent during periods of high network traffic.
E Healthcare call center in US or Canada at 800-437-1171 and other countries at 262-896-2890.
rian.com; China/Asia: china.apps.helpdesk@varian.com; Japan: Japan.Apps.Helpdesk@varian.com; Lati
edical Systems, Inc at 888- 827-4265.
so states that BD will change the issue in the next software version. If customers believe that they ma
d be reviewed for quality assurance purposes in accordance to set departmental or organizational poli
chnical Support at 1-800-558-7044, or your local Service Representative.
ated that Terumo was updating the Operators Manual for all CDI systems and would provide the manu
stems- www.varian.com.
2010 by certified mail.
STOCKERT J70 RF generators with SW versions 1.035 / 1.035J /1.035J70 to 1.037/1.037J70.
m..
754-2000.
The letter also provides RECOMMENDED USER ACTIONS to follow. The Letters go on to reiterate caut
er information or support regarding this issue.
.
gy Help Desk at 1-888-827-4265.
o complete and return a Customer Reply Form via fax to +33(0)1 30 70 39 30. A GE Healthcare service
be scheduled as we receive your business reply form.
ed to you at the time of the update.

ified the product, the problem, and the action needed to be taken by the customer.
sentative.
notice to any all users of CMS software at their organization who are potentially affected by this issue,
hanging the exposure parameters and in order to avoid the problem. Philips will issue a Field Change
94-5398.
and
advise
Stryker
of the new
user_x0019_s
name and
new
the
product,
theMidmark
problem
and
the action
needed
to betheir
taken
bylocation.
the customer.
redQA/RA
Manager,
Diagnostics
Group
310-516-5116.
lve the problem.
se callElekta
(978 )will
687-1501.
6.00.
notify the customers when this solution is available.
800-878-4267.
copy
of the the
communication
the equipment
instruction
use.customer.
Additionally, a field change orde
dathe
product
problem andwith
the action
needed to
be taken for
by the
rfied
obsolescence
byto
providing
us Customers
with their serial
and June
actions
be taken.
were numbers.
instructed to share this information with laboratory sta
ble
since
2009.
800) 360-7909.
orrect
the problem. This letter was sent by US Mail but no return receipt was included.
800-878-4267.
The letter describes the product, problem and action to be taken.
nlecular
all other
countries
contact
the localversion
Philips will
Healthcare
office.
estimates
that
this
software
be available
the first quarter of 2012.
uct
the
problem
and
the
action
needed
to
be
taken
by
the
customer.
or
4354
between
the
hours
of
8
a.m.
5
p.m.
Monday
Friday.
r
(Call
Center)
on
the
Beckman
Coulter
website
at
notice was sent hardcopy via US Mail but there was no return receipt.
States
andreplacement.
Canada, theyAwere
directed
to their
localwill
Beckman
Coulter
Representative.
isk drive
BD field
service
engineer
contact
thecustomers.
customers
to schedule the on site
described
the product, problem,
and
the actions
to be taken
by the
ncy
calculated
from
the
maximum
number
of
ISE
samples
run
per
day
and
activate
the yellow
threshol
are;
complete
and
returnan
the
Customer
Response
Form has
via fax
to approved.
812-931-2410 or mail
to: Hill-Rom
Co
oftware
and will
provide
upgrade
once
the software
been
till
duringAECG
analysis,
users that if they experience this problem, to press the Analyze button
tomers.
return
receiptInstruct
was requested.
wledge receipt. We appreciate your assistance in this matter.
Diagnostics
Service
Department
at 800-638-8663.
pgrade
Tracking
Form
to be completed
and returned via fax at 781-861-4207 or via e-mail at ra-usa@il
Hill-Rom
Technical
Support
at
800-445-3720.
anBCT
Support
Center
at
1-877-3-FYU-BCT
ake the correction to the gantry start angle. In addition, the customers were instructed to complete an
8-9011
or +1
(978)in421-9460.
n to avoid
a delay
obtaining results. The firm is in the process of upgrading their software to avoid th
CaridianBCT
Customer
Service
office.
o "Yes" to avoid
the problem
from
occurring according to written instructions provided in the advisory.
epresentative.
port for any question about this recall.

at 408-830-8023.
ates that this issue will be resolved in Focal version 4.50.00 and above. A "User Notice" will be sent to
t the machine retrofit.
(800) 437-1171.
"FCO 73200029" with any questions.
e installation/re-test instructions with an upgrade kit to rework themselves. The letter states that all L
ange to perform update to 4D Integrated Treatment Console (4DITC) software. For further clarification
ates or Canada. Outside the United States and Canada, contact your local Beckman Coulter Represen
East Asia: seasia.apps.helpdesk@varian.com; China/Asia: china.apps.helpdesk@varian.com; Japan: Jap

system. Varian is preparing a software patch to correct the issue and it will be applied to all OGP v2.6
his situation, the recalling firm Field Service Engineers will be contact customers to schedule a time to
ffected sites in November 2010. The issue will be resolved in the XiO Release 4.70.00, expected to be
nning until the new firmware has been installed. Customers are to share the information in the letter w
10-8188. For other countries please contact your local GE Healthcare Service Representative if you hav
your local Philips representative.

8.
hose within their organization who need to be aware and to alert other parties affiliated with their orga
o instruct each customer to complete the "Fax Return Form" acknowledging receipt of the letter. If cus
ada, or consignees local Beckman Coulter representative.
or consignees/customers local Beckman Coulter representative.
or consignees/customers local Beckman Coulter representative.
8-5074.
chnical Services and Support at 1-800-638-8663.
ted customers on February 7, 2011.
tify them of the need to install the corrected LPI Software.

ion as part of the field action.
and customers' local Customer Service Engineer will install new software on their system when it is av
refer to the letter for what phone number you should call depending on where you are.
report is being moved because the user wants to combine the content of the reports, then the "merge
The notice identified the product, the problem, and a workaround.
4.
hCare Service at 877-777-2432.
d when users go online and activate current software. If the user does not have internet access a repla
t at 1-800-224-6723, option 2 and then option 3.
nused catheters from affected lots for credit and replacement. The letter states that Medtronic AF Solu
4.
advisory listed the problem, clinical impact, and a workaround. The firm will be sending each site a rem
image imported from the treatment planning system. Siemens is currently working on a solution and
issues. Users will be notified as soon as the update for the system is available. The customers were in
act customers when the software is available. Installed systems with the current version of software (
398-3937.
5).
-687-1501.
versions of the software is complete. Versions of the corrections will be provided on a staggered sche
upport team at (203) 601-5200 Extension 9888 or 9889.
ny questions or need additional information about this recall action, Contact Respironics US Customer
mages.com or at 1-800-208-3005.
ss each issue. The letter states that the recalling firm will contact customers to arrange to provide a s
.
ntative at (800) 521-1968.
e with any questions.
that customers could take to avoid the potential risk of the issue. A mandatory update software was d
nt at (727)789-0100.
1-4002, option 4 (available 24 hours a day/7 days per week).
ard is included for the customer to confirm receipt of the User Notice. The firm intends for this issue t
at 1-800 428-2336,.
ice@digison.net.
problem. Device users were requested to complete an attached receipt verification form and return it
pdate for the system is available.
ail at debbie.norris@agfa.com or call at 864-421-1754.
ed in the Operator Manual. Lastly, the notification letter informs the user/customers that the company
or +1-408-716-4700 (non USA) or email: customersupport@accuray.com.
d Lab Results AP macro and/or the Micro Results AP macro on customer systems and will either discuss
422-8766.
endix K.4 of the operator's manual until the ventilator is upgraded with a corrected software. Distribut
are organization.
his issue to all personnel responsible for LOGIX order entry and order authorization at their facility. Cu
mail at clinicaltechnicalservices@cyberonics.com.
258-1946 x5267.
ves will visit each consumer/user and upgrade the version of DICOM Q/R to 1.1.5. Further information i
Service 1-800-521-2818.
and retain a copy of the letter at each computer on which LOGIX OE Server is installed. The customer
eer or the Technical Services Department at 800-722-3774.
es beginning May 25, 2011. A customer information letter was also provided.
ffected units in the field will be corrected in accordance with a rework procedure that has been establis
customers to follow any instructions or recommendations covered in the Notice. The notice instructs
3.
) or +1-408-716-4700 (non USA) or by email: customersupport@accuray.com.

3.
t at (800) 940-3240.
port at (800 ) 940-3240.
1-3826.
-0100.
0.
ware update beginning November 2009.

he US, 44 1992 507740 for any questions about this recall.
ed the notice. For sites not returning the postcard by 5/28/10, the recalling firm will contact them via p
s notification and fax it to ( 817) 916-9087.
task notification and permission to install the hot fix.
e number at 408-830-8023.
resentative at (800) 521-1968.
0 (St Louis Office).
ntains a return reply form that is to be faxed to TAMS as proof of notification.

CO 70800070" with any questions about this recall.
800-878-4267.
the SL75-5 interface. If customers have questions, concerns, or requests, they can email support@im
521-1968.
mplemented until a service patch is created to fix the problem, and that the letter should be placed in
mers with any questions can contact the Director of Regulatory Affairs at (800) 421-1968 or contact the
800-878-4267.
.
Engineer. For further questions please call (440) 483-7000.

to follow until the software was updated. The customers were requested to complete the enclosed cus
ffected units in the field will be corrected in accordance with a rework procedure that has been establis
Center at 1-800-722-9377.
the coDiagnostiX system and enabling the automatic upgrade to occur.
00) 722-9377.
sue can occur. Customers can continue to use the device normally in all other respects. The letter sta
m; RaySearch Americas Director of Customer Support at +1 877 778 3489 or freddie.cardell@raysearch
any questions regarding this Corrective Action Notice.
14) 427-5811 extension 344.
1100.
ent under two years of age. Customers should direct their questions with regards to the letter to their
866-777-0202 and speak to their Support Manager.

90.
Help desk at 888-778-3375.

cted.
tails, or call (727) 789-0100.
ate User Manual. Before doing so, users are to ensure that Desktop Pro R7.01 SP2 is installed on their
t fix that corrected the issue or made the hosparam change that prevents the issue.
return postcard was included for the customer to confirm receipt of the User Notice. The firm intends
Philips Field Service Engineer will be visiting each customer site to install the necessary software upgr
e systems identified with the recalled serial numbers and software versions alluded to in the medical d
w your site ID, please hold and then select option 5 for "Nuclear Medicine" and finally select option 2 f
eviously loaded which introduced this issue were corrected and delivered to all affected customers as a
r your local Beckman Coulter representative.
d Canada contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID or follo
are update is installed. The letter notified the customer that a Philips representative would be installin
ons USA, Inc. at (800) 888-7436.
ure had occurred, but could not conclude what information was contained within the payload. Each pat
covered in the Notice. The letter states that Elekta is working on a new software version and customer
erform the upgrade, and a pre-paid upgrade confirmation postcard that must be returned to Defibtech
Door and Main Processor software, inspecting the main board, and replacing the board, if warranted.
24, 2010.
d in device labeling. For implanted devices, continue normal follow-up.

they have requested and received replacement batteries.
change at no charge.
uide, Infusion Management Guide, and the March 17, 2005 Buretrol Set Urgent Device Correction letter
were directed to 800-289-9793, press 1, then press 3 and ask to transfer to 4674 (8:00 AM to 5:00 PM
with a TELEFAX form to be completed, signed and dated by each customerand faxed back to Radiome
endations.
described in the letter. The firm''s service personnel will visit the customers, remove and replace unit
nd Guidant Represenatatives. Physicians are to perform an in-clinic follow-up exam as soon as possibl
which regular updates on the ongoing actual performance are listed in their Product Performance Rep
ain symbols. The firm''s representatives will visit customers to replace the main circuit board assembly
axter at 1-800-843-7867 to schedule the return of any 6060 Infusion Pump that requires replacement o
evices can be used until the user receives a replacement.
he letter, the customer is provided a copy of an additional page and a CD concerning the function and
lso be recorded on the log.

tion to Guidant. Guidant will be able to analyze the device memory data and estimate remaining long
prior to the representative''s scheduled visit, the letter says that they can telephone their local Field S
knowledgement form be returned to them.
he letter, the customer is provided a copy of an additional page and a CD concerning the function and
ent to the customers and the customers are asked to return the affected device.
dant is currently conducting tests on retrieved devices. Physicians will be advised once more informa
aboratory testing and analysis indicates that the nominal probability of malfunction is higher than thei
tified units for servicing. The accounts were also instructed to respond to the notification within 5 work
enclosed response form, or calling Welch Allyn-MRL Technical Support at 1-800-462-0777. A loaner AE
W A.01.46 is mandatory.
W A.01.46 is mandatory.
Customers are requested to implement one of three workarounds described in the PCA. IN PROCESS
reagent kit has been stored onboard. The accounts were instructed to manually track the onboard stor
Customers
are and
requested
to implement
one oftransitions
three workarounds
described
in the
PCA. IN PROCESS
arousel
ejects,
the system
automatically
from Verification
to Run
Initialization
and then
as not yet received confirmation that this was completed.

a Medical Device Field Correction.
OCESS
OCESS
ealthcare representative will contact the facility and schedule a visit to implement the corrective actio
upgrades of the devices.
brillator/monitor.
e. If patient support goes beyond the capabilities of the PLV 100, 102, or 102b Ventilator is required, Re
for any diagnostic or therapeutic decision, and 'PG mean' values should not be included in any patient
t users have received the PCA letter. Records will be maintained of each official contact, and may be m
re version is scheduled to be released to correct the error.

t users have received the PCA letter. Records will be maintained of each official contact, and may be m
e process of being upgraded.
an enclosed Acknowledgement form.
ack to St. Jude Medical CRMD in Sylmar.

will re-program them upon request for customer satisfaction. The letter will be followed by scheduled o
ty.
they
are running
System
software
version
2.2.2
beginning
2006) and greater it
m. IfThe
Service
Personnel
began
conducting
visits
at (distributed
each customer
site on March
10/31/2005.
ia Service Work Orders. .
immediate upgrade to version 2.2.2, customers are to contact the Clinical Support Center or their loca
line'' To prevent out-of-buffer events users are to complete the enclosed procedure: Calibrating the Wa
e Correction Notice a procedure to mitigate risk until the upgrade is installed.

e firm can be assured they were notified.
ng.
long term solution of updating the software.

he firm mailed an identical letter dated October 2006 to customers for units that were later identified
n 2.5 mbar is used .

de will be released in early 2006. .
ed and international upgrades are ongoing as of 7/7/06.
mendations to avoid its occurrence.
3.831 software was installed on the 700 Series Analyzers and Version 4.14 was installed on the 800 Se
d. The visits/corrections began on: 2/21/06.
nclosed response form. The Letter was sent by US Mail.

and sent to the Branches both in the United States and globally for communication with the affected cu
mode. The letter outlines actions to be taken to avoid mis-identification of patient results.
tall the revised software.
asked to be returned to initiate the upgrade process.

to the customers with activated MRP-7000 and/or AIRIS MRI systems, informs the customers of the pr
orted to Radiometer Medical ApS in Denmark that the necessary corrections had been competed as of:
tion to avoid this issue.
gineers will install software upgrades as necessary. .
ments. A software upgrade is planned to be implemented at the user site''s next regularly scheduled ra
the affected Bayer Healthcare LLC Branches on 8/04/06 for communication with the affected customer
nstruction (FMI) 80114.
e Response form provided.
oftware to their system was mandatory. .
lSoft V.2.0.x can be issued. Individual customer training will be performed at each facility for those iss
quarter of 2006. .
ted scan protocols, which can then be replaced with default protocols or with new customized protocol
the correct software.

w, updated software.
ter also informed the customer a permanent correction to the software was scheduled for release later
2006 and estimated time for FD 20/10 is January 2007). Later, the firm identified 8 additional units and
h which will resolve this issue.
ing the identified treatment plans and that manual input should be used for QA purposes only.
he software limit switch. The Robotics will be re-installed once a permanent solution is available.
RES #35081, Correction Removal Report #1528028-01/31/06-003-C] In response to the resizing issue, a
oftware upgrade [which the firm states address both issues] will be released on or before 2/27/2006 an
ts have been corrected.
same user/customers, at which time, the affected units were upgraded with operating software versio
ce, dated September 20th, 2006, to the customer to notify them of the issue.
to the customers.
that the correction of all units in their inventory as well as those units installed out-in-the-field will bec
. Any patients expected to be using the device longer than 5 months will be provided with 2 replacem
ttery power. In addition consignees are advised to replace their battery every 1 to 2 years.
replacement of these devices prior to ERI is not recommended. As stated in the Product Update, "Dev
replacement of these devices prior to ERI is not recommended. As stated in the Product Update, "Dev
d as replacement components become available.

nd compartment covers, and return the old batteries and covers to Bio-logic Systems in the enclosed p
462-208-313).
cal Pty. Ltd. On 9/27/07, Ellex sent a letter to all consignees, informing them that all modifications by s
eplace batteries older than three years, verify that the batteries are ones of the approved type, and ve
cal Pty. Ltd. On 9/27/07, Ellex sent a letter to all consignees, informing them that all modifications by s
n replacement components become available.
ets or fails design specifications. The recalling firm will reimburse shipping costs.
elivery and severe hypoglycemia. Firm is also including an insert with this information with any Paradig
mp has been exposed to this type of radiation: 18:200, 18:416, 36:416, 19:113, 41:113, 314:432 and 3
replace the old Quick Reference Card with the new one which instructs them to press 'On' and 'Shock'
vice Correction Letter dated 6/22/07 notifying all users of the problem.
vice Correction Letter dated 6/22/07 notifying all users of the problem.
off-on may clear the error. Even if power cycling clears the device, the accounts were instructed to con
message. They were told that a Siemens service representative will contact them within 90 days to sch
t components become available.
and assembly of cosmetic brake or apply caution labels.

he circuit boards.
hnicians will complete a Field Action Certicate acknowledging the successful completion of the update.
he circuit boards.
factured between 3/29/07 and 8/9/07. The letter also indicates the serial numbers affected, and where
mation for requesting additional details. Patients are advised that they may continue to use their S8 flow
ons on 10/16/06.
their units upgraded as replacement components become available.
ons on 10/16/06.
yer is to be included as a supplement to the user manual.
on and effect for the user of the failures, as well as, how to identify whether the Servo-i unit has shown
en on again, using the system on/off buttons. The letter(s) states that software is being developed to c
cility to make corrections to all beds under recall.
vey to the Mallinckrodt. In addition, the notification includes an updated chapter insert (Chapter 11.1)
e or request the repair be done at the Smiths Medical PM, Inc. Technical Service department will return
mponent.
eply form that consignees were requested to fill out and return.
with a loaner device while their unit is being serviced. Distributors were sent a separate letter request
ould be deactivated. After meeting with CDRH's Office of Compliance on August 27, 2007, the recalling
y in their possession.
customers have any questions they were instructed to contact their Toshiba Customer Service Engine
nees as confirmation and understanding of the information received.
within the next few weeks. The alert notification is accompanied by a 'FAX FORM' to be signed and com
ere notified that Naviscan has identified a potential safety issue with all versions of PEM View Software
mer Support to ensure they thoroughly understand the issues and the recommended procedure to pre
urn the pumps to Smiths Medical MD in order for the problem to be corrected.
l consignees via the mail on 2/16/07.

e software upgrade for their device(s) within 45 days.
educe problems pending software upgrades.

pecific to CIC Pro v4.1 software.
educe problems pending software upgrades.
s accessory kit and quality control products used with the Cell-Dyn 1700 system.
s offset problem is to manually enter the MAP based on the readings from the bedside monitor. All Vigi
at have been stored on a PACS System. Phillips in investigating the problem and will provide updates f
at have been stored on a PACS System. Phillips in investigating the problem and will provide updates f
e of charge, beginning Nov. 2007.
fix pending software updates, validation,and full root cause determination.

Customer Reply form acknowledging receipt and understanding of correction letter. Firm recalling to
tation. A customer response form was also included.
ons on 10/16/06.
ons on 10/16/06.
issue in detail.
ssue in detail.
ms are included in their recall package.

be issued shortly by the firm.
to schedule an update, once new software has been validated.
mends that the customer(s) not pre-register their samples. The letter is accompanied by an attached F
signees that did not have affected units. Those consignees will be notified the week of 11/20/06 to dis
patient position prior to marking the patient for therapy to avoid the potential inaccuracy. A software
ucts THC (Cannabinoids) and/or AMPH (Amphetamine) Reagents, were informed of the "field correction
in the notification letter that replacement software, replacement instructions, and installation verificat
rm will contact customer to make arrangements to provide a software upgrade to correct the issue.
ons on 10/16/06.
ons on 10/16/06.
e new software at no charge to the consignee.
a software patch is made available.
rge to all affected customers.
nstruction offset defect by Philips employees.
6/06, prior to issuance of the letter to consignees.
roscopy run, and will contact customers to schedule an install. Installation is expected to begin 10/200
the customer.
e firm's distributors received advance notice of the upgrades 9/13/2007.

are not updated with the new region name. (Letter was sent by US mail). Letter includes immediate us
t, and Director of Surgery at each facility. Recommended actions will be provided as a short-term fix a
omers have any questions they were instructed to contact their Toshiba Customer Service Engineer or
6/06, prior to issuance of the letter to consignees.

led by Philips Field Service Engineers.
n of the image that may not be displayed on the screen. The customers were requested to make sure
ue use of the software when Stereotactic Radiosurgery plans are transfered via DICOM RT. The notifica
The corrective software patch is expected to be installed by October 2007.
The corrective software patch is expected to be installed by October 2007.
th 12 Lead Analysis and Export Option in fixed or flex mode monitoring unitl the software correction is
released to verify that it has been installed.
s to arrange for installation of the solution at no charge.

hanges have already been made to the configuration prior to receipt of this notification, turn each bed
near future.
mware on the devices at their facility by the end of August, 2007; and those accounts who had had dem
ustomer Service Engineer or call (800) 421-1968 and ask for the Regulatory Affairs Department. Cust
version 1.40 installed prior to 12/4/06.
. Users can contact Accuray Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 (non-USA)
hem to schedule a software upgrade when the software becomes available. If customers have any que
provided when it becomes available.
m correction.
Customer Service Representative would be sent to their site to upgrade their system software to vers
new software modification to repair the problem.
Customer Service Representative would be sent to their site to upgrade their system software to vers
ceipt form was sent with the Recall Letter.
eview Flash #PR07-0176-2 client notification dated 10/4/07 was also posted on their website and maile
AN or iPlan RT Dose software in combination with the BrainLAB Target Positioner for Leksell Headring fo
from service. The accounts were informed that their Baxter representative would be in contact with t
heduled. An additional copy of the recall letter was sent by FedEx.
hould verify if their system has been impacted by checking if the catalog numbers listed are reference
<15000 light source hours were notified similarly, and were provided filters and instructions for cleanin
n as possible and no later than 9/26/08. The accounts were advised to not further use the table in con
s. In addition, a letter was issued to physicians to alert them of the situation with regard to current pat
art beginning in March 2008. For additional information, contact 1-800-722-9377.
of the recalled products, to please immediately contact those accounts and advise them of the recall s
sheet, indicating the number of units to be replaced or returned for credit. For additional information,
hcare, Inc. for documented destruction.
h specific problem. Each recall letter also has chart of Cardinal Health contacts support.
ed circuit board assembly replacement kits' lot numbers and asked to return them. An "Update" was m
efore Medtronic provided Important Patient Management Information for the implanting physicians to u
rection is a follow-up activity to the letter that was sent earlier.
d to return the device to be evaluated in the Smiths Medical PM, Inc.
UPS shipping label. Product returned to Mini-Mitter will be quarantined, decontaminated, and repaired
arrange for their return and repair. Alternatively, if removal of the device is not a viable alternative for
complete and return to Arjo Inc., the enclosed customer response form indicating that they have recei
n information card.
om.
for use in an emergency under battery power. The firm recommended keeping the unit in service until
all affected IABP units. A Service Representative will be contacting the hospital to arrange for the repla
letter. The letter advises that the Field Service Engineer has come to their facility to inspect and, if nec
o complete and return to the recalling firm. For additional information, contact 1-800-825-5996.
tive will be contacting them immediately to arrange & service their ventilator. For futher information p
f small fuses/circuit breakers according to the specific load limits per device, which will open the circuit
ncerning this recall please contact 215-660-2418 or Anbu.arasu@draeger.com.
letter for U19 IC-only customers and one letter for U9 IC-only customers. All mailings were conducted
dical Device Correction letter to the firm's customers. The firm has requested their customers to throw
stalled
affected
assemblies
were to suspect
be takenthat
out aofHM
service.
rcutaneous
leadbattery
is confirmed.
If customers
II LVAS patient may have a damaged pe
for a replacement. For additional information, contact 1-888-466-8686 x2041.
925-847-8600 (7 days a week, 8 a.m.-5 p.m. PST). Copies of the press release may be found on the fi
erence issue is to disable the Hands Free Alarm Silence. Users were informed that once a permanent co
ment, pending destruction of non-conforming product.

der to detect a patient disconnect. The long term recommendation was to order the replacement part
l Solutions at 1-650-694-5993.
replacements become available.
ries telemetry system pending replacement of the defective board by service engineers. The Healthca
replaced by VIASYS authorized personnel. Letter also requests consignees to fax or mail back the resp
ar. In addition, St. Jude Medical issued a press release on January 18, 2008 and information concerning
cluded the 3M and Graseby brand large volume infusion pumps in the product field safety notice in the
reat the patient. (voice prompts and tones function normally). 2. If the device is not set to Auto-Analy
e contact firm at 508-652-5594.
ory statements and remedial information provided in the Instructions for Use as well as making provisio
uality Management of Siemens Regional units responsible for reporting to local country authorities and
ror log using System Utilities (Function UTL) and suboption 2, System Error/Message Inquiry. Contact C
d make any necessary corrections.
nfiguration update to correct the problem. A notification confirmation form to be return to the firm was
A second notification addressing the approval and addition of labeling was sent to physicians on 11/15/
rm acknowledging receipt. For additional information, contact 1-800-526-7694.
d at 650-694-5993.
lity to all those who need to be aware of it. A FAX Back form was requested with each letter to ensure s
Service at 1-866-679-9250.
pages provided and to affix the enclosed warning sticker on all workstations. Users will be contacted b
at only images read with CAD markers are affected. The letter requests users to return a confirmation
Users were requested update the software with a corrected version as soon as it becomes available.
efect and is in the process of validating the correction and releasing the corrected software as part of a
d unless the phototherapy booth operator was able to identify and correct the cause of the error. Make
rt the new carotid measurement package and optional customization tools; and 3) an Operator manua
ion will be developed to resolve the issue. A Varian Service Representative will be scheduling a visit to
his issue has been validated.
s, and apply any additional filters to the image BEFORE using the interactive shift or landmark registrat
ct Roland Betz at (925) 246-8407.

form a complete investigation into the event. The accounts were requested to complete and return th
me devices may not be upgradeable. The firm request that all consignees return the notification ackno
E suggest that user contact Technical Support at 1-800-588-7044 (Press Option 2) and ask for Technical
oftware error before the software update was received. For additional information, contact 1-800-348-9
which will eliminate the possibility of shock and burn.
that you only use the Hadlock or Osaka growth tables to perform your EFW Growth Percentile calculat
d will be announced when determined.

94-5993 for assistance.
t Abbott at 1-877-4ABBOTT.
to monitor lost' alarm on iCentral." For additional information, contact 1-800-558-7044.
Zoom rather than pan-Zoom; product correction stating that a GE Healthcare Rep will contact consigne
bruary 16, 2007. A Dear Doctor letter was also issued instructing surgeons to upgrade all Offline Progra
ange for service
abroad.
structions
for changing
the auto analyze setup option for the LP 12 and LP20 were attached to the lette
ate this limitation.
Customers are requested to fill out and return the response form and to contact BD Customer Support
or the PFILS Patch instructions for installation of the software patch. The accounts were advised that th
Agfa support for assistance in backing out of this version to apply the required version for the Agfa soft
ements to install it.

for assistance.
reported that the upgraded software had been installed at all affected sites.
ng beep when you make your selection. Customers are asked to review the attached list of serial numb
rd that contains the defective software will be replaced. The Field Action Plan is expected to be comple
ed and installed at no cost to each user as noted in the recall notification. Telephone contact was provi
cted yet).
tered as GFR <60, it should be typed as GFR less than 60. The customers were requested to make sur
ce versa. The letter provided the users with safety instructions to follow until the software is updated.
ter. For additional information contact 1-800-526-7694.

ted. The accounts were requested to contact GE Tech Support at 800-433-2009 to schedule a time to
are updates.
ced SieClear compounding setting after an L/R invert action with Biopsy guidelines on-screen.
s that a Datascope Service Representative will be contacting them to arrange for the upgrade.
ncluded that the associated risk was low.
Customers are requested to fax back confirmation to AMO (408-773-7055).
on the recall. A new software version will be provided. For assistance contact Siemens at 1-925-246rvice@viasyshc.com or gsiservice@cardinalhealth.com.
Nursing and director of Biomedical engineering / IT. The letter also described the problem, affected Pro
o do not respond to the recall communication will be visit ed and/or telephoned for follow up.
he software. The Siemens Service organization has coordinated the implementation of the field correct
ct Cardinal Health NeuroCare Division at 1-608-271-3333 for assistance.
m the upgrade. Until new software is installed, customers are being advised to use the 12 lead modul
ns. A software upgrade is currently being developed. For assistance, contact Varian Medical Systems
2008-03-06.
an ISOLOC Device Correction Notification Customer Feedback form which is to be completed and retur
omplete instructions regarding this error. A new version that corrects this problem is available on the D
sed that the device is safe to use when operating according to the Instructions for Use. EKOS contact n
a software fix at each consignee.
GE Field Engineer site visit was also conducted to implement the correction (FMI No, 60745 & 60746),
he new software version can be installed. A software patch to permanently resolve the issue will be in
Save State when a custom label has been ordered, and not to include leading or trailing blank charac
rs to upgrade to the corrected version.

ees. For foreign consignees, letters will be translated as necessary and distributed with return proof of
time until the new software version can be installed. A software patch to permanently resolve the issu
n received October 4, 2007: a software patch to fix PETsyngo 5.0 was released, software patch to fix P
n of energies 5MeV and below with field sizes smaller than 6cm x 6cm. The firm suggested using the fi
n was received and understood. If a FAX Back form is not received, the account will be contacted by tel
ed directly to the GE Healthcare service engineers who provide the modification at the customer site.
diologist/ Cardiologist. A correction letter identified a short term recommendation to perform a system
on will be in the form of a software upgrade and will be performed remotely by Philips service personn
install the software update beginning 9/12/08.
software modification.
on will be released in October 2008. Once software is available, the firm will begin correcting the field.
en performing surgery with the da Vinci S Surgical System and being prepared to convert to alternative
h the corrective action to upgrade all affected systems.

correct the issue. This correction was released in October 2007.
would contact them to schedule a visit for a software correction installation.
brator Set CDs with only one lot of calibrator assignment values until a new version of software is avail
ion will be developed to resolve the issue. A Varian Service Representative will be scheduling a visit to
er also stated that BD Biosciences rep will contact the users when the new software is available. User
e the Service personnel log that information through Siemens internal web or reporting tools into the S
able. If customers have any questions they were instructed to contact their or call (800) 421-1968 and
o upgrade the software.
the modification requested to address the problem, when a corrected software version is available.
e UI IM086/08/S for the affected versions of syngo Imaging that will resolve the potential malfunction.
s also issued. Software patch planned for release in June 2008.
ps at 1-866-246-7316 for assistance.
umstances a pressure spike will occur upon reaching Pmax +5mbar (cmH2O) which with software vers
de the software.
t ECG reports to determine if any patients were actually affected and to notify the firm. AGFA Healthca
resentatives providing new software, when software is available. This should be issued by the end of J
Change
until
softwareReply
at their
siteindicating
can be updated
to the
corrected
version.
software patch
i
eturn
theoccurs,
enclosed
Customer
Form,
that they
have
disseminated
theAinformation
to the
y or by clearing the patient database regularly." The letter further informed the customers that a Phil
notification and associated FCO 22945704-08292008-004.
hey would be contacted by a Baxter representative to schedule an installation of the software upgrade
on of software upgrade.
will provide updates, free of charge, when they become available. If you have questions concerning th
ns. The firm will be installing Safety Adaptation Board and software into all the affected DR3000 system
software patch within the next 6-8 weeks.
h will be available Spring 2008.
erway, designated to start on 12/21/2007, and the correction is expected to be completed within 45 da
will notify users when it becomes available. For additional information, contact 888-827-4265.
ted. All consignees notified by certified mail. Contact Siemens Medical Solutions USA, Inc. at 1-925-24
e upgrade by the distributor. Contact NEUISYS Service Support Department at 1-877-299-9052 for assi
of the software to Hologic in a pre-paid envelope.
which will eliminate the possibility of shock and burn.
any questions contact Karen Uyesugi at (408) 523-2100.
o determine specific clinical implications for their patients. The firm states that this issue will be resolv
the issue, which will be installed on the affected systems when it is released.
"Delete All Images" button until any pending Autopush operation is complete. FCO 70800067 will be
released to correct the issue.
visit each site and make configuration changes to resolve this issue.
ons were directed to GE Technical Support at 888-778-3373 or 905-479-1249. The accounts were requ
ion. Philips will deliver a software upgrade to correct the problem.
ed software has been validated and released for distribution.
ware, due out first quarter 2008, will fix this.

st class mail on 9/24/08. If there were any questions, the customer was to contact Tech Support at 1-8
09 and April 2009 , software upgrade installed and new Operating Manuals provided.
mation provided in the telephone contact and stated to "Immediately perform one of the following act
Hospira representative for assistance. The letter stated that customers may continue to use and moni
cking of servicing.
0-826-4610 from 8:00 AM to 5:00 PM PST.

ents. AN Device Call Center will make arrangements for the service or replacement of the recalled pu
return the card along with the affected batteries as instructed. Questions should be directed to Abbot
tions or concerns regarding the notification.

plusbatteryhelp.com/.
n interruption of therapy with any failure code. The letters also provided information about the hazard
vice back to the water drain, but the LCD display will be garbled and the timer will not operate. If this p
uctions (included "Recall Confirmation" form fax to 973-790-4150), Product Correction and Contact Info
ment or discounted new purchase.

n via fax (732-667-1903) to Maquet Inc. RA/QA. Direct questions to your local Maquet Inc. representat
complete the attached Recall Response Form which accompanies the recall notification. The notificatio
on at 1.800.543.3267.
shing to perform the work themselves. For additional information, contact Terumo CVS Customer Serv
VS Customer Service at 1-800-292-6551 (US only) or respond by telephone at 1-800-521-2818. Please
rvice Representative.
Hospital Risk Manager, Hospital Administrator and Purchasing and Central Supply. The letter asked tha
m's website. Direct questions about this recall to Medtronic, Inc. by calling 1-763-514-4000.
es can be found at: www.cardinalhealth.com/alaris/medical-device-recall/ (This informatio.
ntact Information. The second letter dated March 10, 2009 includes 700 serial numbers that were miss
ected Devices, Description of the Problem, Advise on Action to be Taken by the User, Results of Investig
Medical at 800-722-3423.
, or fax. Affected products received by Teleflex Medical will be destroyed or reworked and replacement
product, please contact Stryker Instruments at 1-800-800-4236, extension 3808 or extension 4056.
1-800-722-9377.
and stated that as a general practice tomograms should be reviewed carefully using the Xeleris Volum
quirements in full.
d with this report package contain additional details regarding configuration options.
ain in service and back-up monitor should be available in the event of a failure. Zoll's technical suppo
ot checked. They also were advised that a Siemens Customer Service Representative would contact th
ngineers will contact customers to schedule a time to visit site and correct affected consoles. Please co
enclosed pre-paid addressed envelope to the Mako Surgical Corporation. Please direct questions to yo
up to be conducted via telephone.
ting the license at the affected sites.
software and will be installed at no cost to the customer.
mailed to the physician on Dec 10, 2008. The letter described the issue and the product involved. The l
on.
on.
ding customers with the recommended workaround. The workaround is to only print from the Viewer sc
d product and/or quality problems via the FDA's MedWatch Program.

the upgraded software and instructions to follow.
7485 outside the U.S., completed at www.cozmore.com/notice or calling 1-800-501-5748 in the U.S.
ributors. The letter advised to install the software upgrades for any units in stock or to forward the sof
eliver the notifications via firm representatives.
oard or Single Board Computer, and that instruments containing versions of 4.A software are not affect
rect questions to GE Healthcare at 1-800-558-7044, Option 2 and ask for Technical Support or contact
ware fix for the problem. If further clarification is needed, users should contact their Varian Customer S
grades on the affected beds. Please direct questions to Stryker Medical at 1-269-324-6644.
grades on the affected beds. Please direct questions to Stryker Medical at 1-269-324-6644.
Customer Response Form and faxing it to the number indicated on the form. Questions or concerns sh
om customers in the US should be directed to Customer Support at 1-877-4ABBOTT. Customers outsid
were directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-4371-800-437-1171 in the US or Canada or 1-262-896-2890 if outside the US.
e software is updated. Any questions were directed to the Remote Online Center, Field Engineer or the
A permanent software based solution will be provided to customers when completed. They anticipate
n Coulter Representative.
planation of Live Gate and actions to be taken. For further information, please contact Beckman Coult
aging facilities to exercise caution in monitoring the amount of cumulative fluoroscopy time when the
and Service organizations, informing them of the issue.

eloped and will be installed on affected systems when it becomes available.
gnition issue on the console(s).
e Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were r
act Information. The first batch of letters was received by customers on 5/28/08. For further informati
vices and that a Medtronic Representative will contact the doctor to make arrangements to update the
e: Customer Care Center (1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy
y of "left", "anterior" and "posterior"markings, e.g. by checking the position of the spine with respect t
e US, please contact your local hematology customer support representative.
entative will contact customers to arrange for the software upgrade of the Panorama(s) in their facility.
re reference. Questions or concerns should be directed to Roche Diagnostics Technical Support at 1-80
your local field support representative or the Customer Advocacy Department at Customer.Advocacy@
estions should be directed to Carl Zeiss Meditec, Inc. Customer Care at 1-800-341-6968.
hen the conical collimators are inserted. The accounts would be contacted by a service representative
rt at 1.800.879.9799, if there are any questions.
act Siemens Medical Solutions USA, Inc. at 1-610-448-4500.

questions were directed to the Remote Online Center, Field Engineer or the GE Customer Care Center a
tions, Corrective Action and Contact Information.
their patients receive in addition to the critical care worklist.
charge. A Philips representative will notify customers when the software correction becomes available
or the affected products to correct the problem. The letter was sent via certified mail.
ugust 15, 2009. A Mandatory Service Bulletin will be deployed to correct the problem in the software.
oblem is remediated and the firm notifies customers. If there are any questions, customers are to cont
ty Instructions, and Contact Information.
and return the completed "Verification Form" via mail, e-mail or fax to Cardinal Health-NeuroCare. Fur
t bill customers for the Guardian Service until the problem is remediated and Stryker notifies customer
nt notes which pertain to syngo Imaging versions VB20G and VB30A. Update is a prerequisite for the fo
visit was documented.
h questions or concerns about this correction at 1-800-722-9377.
ep. will be contacting each customer and making arrangements to come out and install a software upg
ed information noted in the "URGENT - Field Safety Notice". Direct questions to your local Philips repr
er information, please contact Hitachi Medical Systems America Inc. by telephone at 330-425-1313.
will be updated free of charge. Direct questions about the notification letter to Drager Medical, Inc. by
or additional information, contact Philips at 650-293-2624.
release of software is installed. In the interest of safety, the preventive measures should be performed
g this issue are directed to the local SIEMENS Uptime Service Center or +49 (9131) 84-2056.
nstalled on their system. Any questions were directed to GE Technical Support at 888-778-3375 or 905w until the software is updated. Any questions were directed to the Remote Online Center, Field Engine
sory is placed in the system's instructions for use and contact their SIEMENS Uptime Service Senter if t
ms.neusoft.com) or contact Philips Medical Systems North America Co. Phillips at 425-487-7602.
ed and will be installed on affected systems by sygo's service representatives when it becomes availab
-800-709-6726.
sonnel. For further information or support concerning this issue, please contact your local Philips repre
ll Questionnaire for instructions on what to do with the recalled product: The recall should be carried o
beginning in June, 2008, in order to address this issue. It also states that a Hitachi Service Rep. will be
he potential issue and both interim and formal mitigation. Acknowledgment, via FAX-Back, that the info
nce of estrogen (ER) nuclear receptor protein only. Performance characteristics of the product, when u
ssue are directed to the local SIEMENS Uptime Service Center.

ions via certified mail. A software correction is planned.
es can be found at: www.cardinalhealth.com/alaris/medical-device-recall/ (This informatio.
in HW/SW Update Rev. E 820-0178-00.
r software version downgraded to 2.05.00.
ete and sign the enclosed Business Reply Form and fax a copy to 866-521-2762. Upon receipt of the fo
to Distributors describing the problem and giving them instructions for notifying customers and action
replacement. At this time, no other action, reprogramming or change in the frequency of follow-up is r
Monitor/Defibrillator. Should you have any questions or concerns about the Device Correction, please
eeded, customers in the US can contact Clinical Technical Support at 866-882-8804 or via email at clin
ll.
by the customer.
wing
the videotodemonstration
directed
to thesub-accounts.
Ohio Medical They
technical
line at
ere
instructed
sub-recall the were
product
from their
wereassistance
also requested
to 224-430-1
complete
onsignees to fill out the attached Medtronic Recall Certificate (FCA 1005), and return it to Medtronics.
tion is available from the company by calling 800-595-9709.
hine.mcbride@siemens.com.
roviding
thefor
reason
for replacement.
the recall, instructions, and customer service contact information to arrange for
eps
to take
product
complete and return the "Urgent Recall Notice Confirmation Form". To return Power Cords, for question
ay be enhanced by including a copy of this recall notification letter.
ard notification of the recall to customers if it has been further distributed.

dnot
to be
follow
recommended
daily Operator
Checklist
while
service
areremain
scheduled.
Custom
hould
also
run
battery
insertion
test. If the
devicesteps,
passes
the test,
theupdates
AED may
in service
un
sent
in a
for
upgrading.
rs when FDA approves their design upgrade for returning devices for service. In the interim, hospitals s
lator paddles, disregard paddles and manually ensure good paddlet-to-patient contact, and 3) if monit
5089.
ation, please contact the firm at 888-826-9702.
ory and promptly return it to CareFusion for replacement.
providing information related to the recall was activated on 11/3/09.
nt of the affected assembly. The firm will not be issuing a seperate notification. For questions regardin
cy back-out buttoms to recover the X-ray image. A GE service representative will affix a label to the de
a software correction.
by returning the Recall Response Card to CareFusion by postage-paid, self-addressed mail, fax or emai
a software and hardware upgrade.
d resolution.
er 30, 2008). Customers are asked to follow the _x001C_Actions to be taken by customer/user_x001D_
can be contacted at 44 161 926 0011 to arrange return material authorization and replacement of affe
s.
mblies. The speaker replacement assembly is expected to be available in 8 weeks.

cal
youEngineering.
observe this issue, remove the device from service and contact CareFusion Recall Center immedia
visit. Customers without a service contract will be contacted by Terumo representative to schedule an
ctions
below until the software has been loaded on their system.
e at 1-800-722-9377.
recalibration is required after approximately 50,000 compression cycles. Consignees returning device
n by consignees.
heir inventory and the product replacement will be sent to them. Contact Inverness Medical Technica
s
in conjunction
Access
AccuTnI
(REF
A78803)
should beand
reviewed
in the
context
of other d
y tested
the physician
the
nextwith
time
the
patient
is seen
medical
facility.
A Confirmation
Form
is also
askedin
tothe
beclinic.
completed
returned
to Smiths
Medical.
placement plan for all INOMAX DS drug-delivery systems was described. Customers can contact Ikaria C
were also sent a Boston Scientific letter dated September 9, 2009. The letter addressed Background
Contact Information. "ApexPro Telemetry System Operator's Manual Supplement for SpO2 was enclose
2484 or. AED195@cardiacscience.com to arrange for replacement(s).

ntact the customer to fix the affected device at no cost. Questions are to be directed to Spacelabs Me
vices Representative.
ons and Contact Information. If you have any questions, please contact Technical Support at 1-800-558
y.com.
C) if the labeling is present as shown in the drawing. If the labeling is missing, a Philips rep should be
re asked to complete a Field Safety Alert Acknowledgement/Return Form and fax to the firm. Consignee
given upon receipt of the reimbursement claim invoice.
receipt of the notification. If the client wishes to receive the correction, they should document a reque
010, Option 1.
ware correction is planned.
ption 8.
on. Consignees will either receive a software upgrade on site by a third party or replacement product
mpleted 7/31/2007.
77-657-8118 to obtain a free software upgrade.

issued to the health care provider/prescribing physician for the affected users.
ive, they may be contacted by phone, e-mail or fax. A record of these contacts will be maintained. Affe
cked via acknowledgement cards mailed, faxed, or emailed. The local Stryker Sales Representative wi
ed information for returning the pumps to Smiths Medical for the upgrade. For further information plea
ovision of a software upgrade by the firm. Consignees will be contacted by a GE Healthcare representa
1-800-874-7378.
ining the corrective fix. Customers can contact Impac Software at 800 488-4672.
rough the local representatives.
Philips Customer Care Center with questions or concerns about this correction at 1-800-722-9377.
signees to update the ICS G2 system at free of charge.

be delivered electronically to all clients. Client was asked to acknowledge receipt of the task and grant
rder 764 00 551 059 "Replacement of iViewGT R3.4 installer disk"supersedes FCO 764 00 551 053.
77, #5 #2 and reference "FCO 71200025".
o Abbott Laboratories, Inc. by calling 1-972-518-6000.
Sidebar, McKesson recommends that you save the voice clip to the desired study first, before browsin
ed to the firm's Customer Support at support@vitalimages.com or at 1-800-208-3005.
ervice Representative.
e of cost.
nd AT elekta.com, or After Sales gustaf.piehl AT elekta.com..
t wishes to receive the correction, they should document a request to load the software.
ces in the U.K. at telephone 44 (0)-1293-654200.
eipt of this task and update the task with permission to load the required correction.
e, a self-addressed postcard was enclosed for the customer to return as evidence they received and u
d in the letter is performed. Customers with questions should call the company at 781-557-3000.
are is updated. The customers were requested to complete the enclosed customer reply form and fax t
trostatic x-ray imaging system. Customers were to complete the attached customer reply form. Ques
. A software patch has been verified and validated and will be installed on all affected units. The new
ill be remedied by software versions 4.0.2 and later. Questions should be directed towards TomoThera
act Philips Call Center at 800-772-9377, #5, #2.
ceipt of this Task and indicate whether they would like to take the correction at this time. When the cli
re are symptoms for the reported issues. The issue will be resolved with a Software-Update for each a
creating the canned message in the setup file, edit and re-save all canned messages in SoftPath. Clien
mber" should be set to "0" so the user is not prompted to reuse the same case number. Client was ask
rring. Attached to the letter were two pages explaining the proper process for closing the pump door.
ius system at this time, clinicians should weigh the risks/benefits to the patients before continuing the
ions you may call (408) 541-2140 ext.341.
. The accounts were requested to verify that the InfusOR and Mini-Infuser will power-on before use; if t
ed with the letter, to be applied to the back of the TEG unit. The accounts were requested to complete
ns, they were to contact Advanced Instruments Product Service Manager at 781-471-2147 or via emai
ed out the devices.

urns.com on January 11, 2011.
ative.
the defect free of charge and provide an updated Operator Manual and configuration update to correc
nue use of the pump and contact Hospira Global Product Safety and Complaints at 1-800-441-4100. T
rd, (Attachment A-2).
ps.helpdesk@varian.com; Japan: Japan.apps.helpdesk@varian.com; Latin America: soporte.al@varian.

600.
m via fax to 303-699-9854 and to contact ConMed Electrosurgery Technical Services at 800-552-0138 t
etrofitted or replaced, specific instructions were given to reduce the risk of a device malfunction. The
d be completed and returned via fax. Customers were instructed to report any suspected incidents re
e and return. Terumo CVS will schedule the return of affected products for inspection and replacement
Coulter Representative.
s specific timeframe. Customers with devices already known to require repair and/or servicing will be
ll 609-936-2485.
re component in the system. Customers would be contacted to schedule for the hardware exchange.
772-6446 if shortened pulses are detected. Contact your local sales representative or call Customer S
entative.
r area.
inspection and necessary replacement had been completed. A customer response form was also inclu
rded. This correction will be done free of charge for customers.
cluding the screen display) are fully operation and undamaged.
ow the instructions provided on how to safely use the device until the unit can be serviced by Philips In
ontact the Smith & Nephew Endoscopy Returns Group at 800-343-5717 (option 3) for a Return Authoriz
ng the letter should be directed to the Varian Oncology Help Desk Contact Information at USA and Cana
COULTER
Hematology
Analyzer
with Autoloader.
Thestates
letter that
provides
customersvalue
with is
ansignifi
expl
umo CVS MAXM
Customer
Service at
1-800-521-2818.
The letter
whenthe
a displayed
een
forwarded
to
another
facility,
a
copy
of
the
letter
was
to
be
sent
to
them.
The
Business
Reply
card
will
have
same effect
to eliminate
the potential
impact
a rarethat
spike
on the
glucose and
lactate
se
umo
CVSthe
Customer
Service
at 1-800-521-2818.
The
letterofstates
when
a displayed
value
is signifi
ssue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
upport/supportrequests.
er
representative.
Product
Correction, Safety Instruction and Contact Information.
by the customer.
eOperators
letter states that if the recalled products have been further distributed, forward this letter immediate
ustomers. Manual in conjunction with the attached Troubleshooting Checklist; be aware if performing M
Customers were asked to return the postcard as proof of receipt and their understanding of the Safe
tion is available.
scheduleupdate
an appointment
installing
electronic
board on
the 2008T
machines
at the
customers'
software
and were for
instructed
to the
install
the CELL-DYN
Emerald
according
to the
attached
instru
m
to
5:30pm
MT,
Monday
thru
Friday).
an attached form to AMO via fax at the regional fax number.
cal situation, the user should verify the accuracy by independent means before treating. The letter inc
each time they acquire a new FlexMap and amend their local procedures to include the FlexMap Chec
nventory.
problem. The letters described the issue and the FCO asked the Service Engineers to confirm their rec
e affected equipment until retrofit was completed. Questions were to be directed to the GE Service Ce
covered in the Notice. For questions call +44(0)1293 654200.
consignees to distribute this notice to any and all users of IMPAC software that may potentially be affe
ve a problem. Customers should include the Safety Advisory Notice including the Safety Notice from E
elease.
elease is available."
f their CRS Remote product - Software Version 7.8_HL would be performed.

en layout).
ference, this document will be posted to the Varian customer support website: http://www.MyVarian.co
hnical Service at 1-800-262-4911.
mers were instructed to notify their consignees if they have further distributed the affected product. T
eger Service Representatives will schedule time with customers to upgrade the software in affected mo
10B06, 11.
ons 7.1.4 or later. Contact your local Picis support representative for questions regarding this notice.
@sonosite.com.
s of high network traffic. Instructions were provided to download an Appendix to Orthoralix DDE User M
at 262-896-2890.
pdesk@varian.com; Latin America: soporte.al@varian.com; Internet: Oncology Systems-www.myvarian
ers believe that they may have analyzed sample files by utilizing the Undo function, then it is recomme
al or organizational policies. The firm updated the procedure and enclosed a copy with the letter. It w
would provide the manuals to all users when available. Consignees with questions should call 1-800-5
7/1.037J70.
s go on to reiterate caution and warnings from Eclipse instructions for use.
All appropriate personnel
A GE Healthcare service representative will contact customers if the updated software version is requi
y affected by this issue, and complete and return the attached postcard to confirm receipt of the Safety
ill issue a Field Change Order (FCO) to resolve the issue by updating the system software free of charg
ally, a field change order was released on September 26, 2011, customers will be receiving release no
tion with laboratory staff and retain this notification as part of their laboratory Quality System docume
ntative.
to schedule the on site visit.
vate
the yellow
threshold
alarm on
theState
system.
Customers
with question
andAttn:
concerns
directed J1
to
0 or mail
to: Hill-Rom
Company,
1069
Route
46 E, Batesville,
IN 47006,
MOD are
Coordinator
press the Analyze button again, and contact ZOLL Technical Service for the software upgrade kit. The l
r via e-mail at ra-usa@ilww.com.

nstructed to complete and return the Confirmation of Receipt via fax to: North America and Asia at 702
heir software to avoid the issue and will contact customers to arrange for an update to their monitors.
rovided in the advisory. This problem has existed since Release 4.3.1 and is expected to be resolved w
r Notice" will be sent to all users still using the affected software notifying them of the updated softwa
e letter states that all Life Pulse ventilators in clinical use must be upgraded and there is no charge for
For further clarification, contact your local Varian Customer Support District or Regional Manager. The
kman Coulter Representative.
@varian.com; Japan: Japan.Apps.Helpdesk@varian.com, and Latin America: soporte.al@varian.com; In

applied to all OGP v2.6 and v2.6.1 systems. Customers are to advise the appropriate personnel of the
rs to schedule a time to install a free software update. If customers have any questions about this corr
4.70.00, expected to be available in July 2011.

nformation in the letter with all users, reviewing radiologist, and the clinical engineering or Biomedical
epresentative if you have any questions or concerns regarding this notifi.
affiliated with their organization that are affected by this advisory notice.
ceipt of the letter. If customers have questions regarding the letter or the upgrade, they should contac
eir system when it is available. Customers should direct their questions to their local service support p
reports, then the "merge" function should be utilized. The letter also states that a software enhancem
e internet access a replacement CD can be ordered from Technical Support at 866 - 531 -7365. Questi
s that Medtronic AF Solution representative will assist customers with the return of affected product. F
e sending each site a reminder that the issues is resolved.

rking on a solution and will notify customers as soon as the update is available. The letter should be i
. The customers were instructed to include Customer Safety Advisory notice in their syngo RT Therapi
nt version of software ( version 4.23) will begin to receive the corrected software April 2011. Previous
ded on a staggered schedule. Customers will be notified by e-mail. Questions regarding this notice are
espironics US Customer Service at 1-800-345-6443 for customers residing in the USA or +011 (203)697
o arrange to provide a software upgrade to all affected systems at no cost. For any questions concerni
y update software was developed and will be installed free of charge. Customers should have been co
m intends for this issue to be corrected in Monaco Release 3.00 in March 2011.
ation form and return it to Varian BrachyTherapy via fax or e-mail. Call the Contact Service Dispatch n
mers that the company will be installing new software on the recalled systems in order to revise the la
s and will either discuss with them the irregularities requiring change or reconfigure macros as necess
cted software. Distributors will upgrade the affected devices with the corrected software as soon as p
tion at their facility. Customers are instructed to retain a copy of the letter at each computer on which
.5. Further information is available by contacting Medtronic Navigation Technical Services at 1-800-595
nstalled. The customer were also requested to complete the attached customer reply form and fax it t
e that has been established by HemoCue AB.

e. The notice instructs Users to file this document in the Important Notice section of the appropriate U
m will contact them via phone or email to confirm receipt of the notice. The notice also informed the co
y can email support@impac.com or one of the numbers listed in the letter for the applicable country. T
ter should be placed in the software's operator's manual to be seen by all who utilize the software.
421-1968 or contact their local Representative at (800) 521-1968.
mplete the enclosed customer reply form and fax the completed form to 847-620-2780. Any questions
e that has been established by HemoCue AB.
respects. The letter states that the firm is working on a software modification which will permanently fi
eddie.cardell@raysearchlabs.com.
rds to the letter to their local Siemens Service organization. A Siemens Representative will update the
SP2 is installed on their treatment control system. If it is not installed, customers are to contact their
Notice. The firm intends for this issue to be corrected in Monaco Release 3.00 in March 2011.
necessary software upgrades. Contact the Customer Care Solutions Center at 1-800-722-9377 for ques
uded to in the medical device correction notification. Lastly, the notification states that Philips Medica
finally select option 2 for "PET" support. In all other countries, the local Philips Healthcare office shou
affected customers as a mandatory correction in hot fixes 1.7199.8 and 1.7200.8 and higher.
5: Enter Site ID or follow the prompts).
tative would be installing a software upgrade in order to address the referenced software issues free-of
n the payload. Each patient has had previous and subsequent payloads that have processed and disp
re version and customers will receive the future version when released. For questions contact your loc
e returned to Defibtech upon completion.
he board, if warranted. A Field Correction Information Form was included in the letter for customers to
Device Correction letter to be provided to all users of the Colleague pump. Baxter informed the accou
74 (8:00 AM to 5:00 PM CST).
faxed back to Radiometer Medical ApS. The form documents that the instructions provided in theField
remove and replace units.

exam as soon as possible with patients implanted with affected devices.
roduct Performance Report. Medtronic is providing a replacement device should the Physician and pati

n circuit board assembly.
requires replacement of the circuit board.
erning the function and operation of the new software, which is to be added to the customer''s Operat
stimate remaining longevity and provide individualized follow-up and replacement guidelines. Subseq
phone their local Field Service Rep. and make arrangements to have the modification performed at the
erning the function and operation of the new software, which is to be added to the customer''s Operat
ised once more information is available.

ction is higher than their earlier prediction. Non-implanted devices have been retrieved. .
otification within 5 working days if the unit has displayed the Defib Comm error, and within 30 days if
-462-0777. A loaner AED 20 will then be sent to the consignee with instrucitons on how to return their
the PCA. IN PROCESS
y track the onboard storage time for the two lots, and discard the kits after 30 days of onboard storage
the
PCA. IN PROCESS
n
Initialization
and then to Awaiting Sample 4) The Worklist is continued or a new Worklist is loaded an
ment the corrective action at no charge.
Ventilator is required, Respironics will make arrangements to loan the customer with a suitable substitu
included in any patient documentation. .
l contact, and may be made available upon request.
l contact, and may be made available upon request.
followed by scheduled on-site visit to reset the internal memory parameter of the neurostimulator.
rch
2006) and greater it will detect the premature out-of-buffer state, thus preventing the potential for
31/2005.
port Center or their local Beckman Coulter representative.
dure: Calibrating the Wash Buffet
at were later identified as being subject to the recall.
s installed on the 800 Series Analyzers. According to the firm, these software corrections were verified
tion with the affected customers.

ient results.
the customers of the problem, and states that a HMSA Service (person) will be contacting the custom
d been competed as of: 4/15/2005.
t regularly scheduled radiation source exchange. A response form is enclosed with the notification and
h the affected customers worldwide. .
ach facility for those issues identified in the letter specific to their software version. At that time the m
ew customized protocols.
heduled for release later in the year.

ed 8 additional units and issued a letter on 12/11/06 to affected customers.
A purposes only.
lution is available.
e to the resizing issue, a second software upgrade [which the firm states address both issues] will be r
n or before 2/27/2006 and this correction will be performed by HMSA''s service personnel during each c
perating software version 2.12. The firm''s recall/corrective action was scheduled for completion by 3/
out-in-the-field will becompleted by 6/15/2006. .
ovided with 2 replacement Battery Packs. They will be instructed to return their existing packs in the s
1 to 2 years.
e Product Update, "Devices that have triggered charge time-based ERI or EOL during mid-life have sev
e Product Update, "Devices that have triggered charge time-based ERI or EOL during mid-life have sev
ystems in the enclosed pre-paid shipping container, along with the completed accounting form.
hat all modifications by service technicians' have been completed, and that their Solitaire LP4532 laser
e approved type, and verify battery condition.
hat all modifications by service technicians' have been completed, and that their Solitaire LP4532 laser
mation with any Paradigm infusion pumps shipped to new customers.

3, 41:113, 314:432 and 302:435:XXXX:0006. If the pump displays any of the codes, the user was reque
o press 'On' and 'Shock' buttons firmly.
s were instructed to contact Welch Allyn - MRL to obtain priority servicing of the affected unit. The acc
m within 90 days to schedule the repair of the c.cam at no cost to the end user. Any questions regard
mpletion of the update.
bers affected, and where the serial number is located - upper left hand corner of the back panel of the
tinue to use their S8 flow generators until a replacement unit is provided. ResMed is instructing patient
e Servo-i unit has shown any failure indications.

e is being developed to correct the problem.
er insert (Chapter 11.1) for the injector system's product manual that emphasize the separation betwe
e department will return their monitors for repair.
separate letter request they provide their customer names to the firm so that the firm can send letter
27, 2007, the recalling firm committed to total product removal of the device. Notification will begin i
ustomer Service Engineer or call (800) 421-1968 and ask for the Regulatory Affairs Department.
RM' to be signed and completed by each customer in order to verify that the alert notification has been
ns of PEM View Software.
ended procedure to prevent these issues from occurring.
bedside monitor. All Vigilance II calculations from the MAP have been re-verified to be correct when the
nd will provide updates free of charge when completed.
nd will provide updates free of charge when completed.
etter. Firm recalling to hospital/user level.
panied by an attached FAX FORM which the customer is asked to sign and complete in order to verify r
week of 11/20/06 to disregard the previous letter.
inaccuracy. A software update will be installed to correct this problem by a GE representative.
d of the "field correction" by US Postal Service letter, provided with a new Assay Data Disk (ADD #546
and installation verification forms are included in their recall package. Domestic Consignees will have p
to correct the issue.
xpected to begin 10/2007 and be completed 06/2008.
r includes immediate user preventive action to remedy both issues. A response form is included for co
ed as a short-term fix and a long-term fix of the software will be issued shortly.
mer Service Engineer or call (800) 421-1968 and ask for the Regulatory Affairs Department. Customers
requested to make sure that all necessary physicians and personnel at their location are made aware o
a DICOM RT. The notification offered that firmware would be upgraded during scheduled service visit.
he software correction is made.
tification, turn each bedside monitor "off " and then "on" in order to reset the system-Customer Care C
counts who had had demonstration units in their possession, advising them to notify their sales represe
airs Department. Customers were also instructed to distribute this information to all users of the prod
08-716-4700 (non-USA) or customersupport@accuray.com.

ustomers have any questions they were instructed to contact their or call (800) 421-1968 and ask for
system software to version syngeo MI Applications 2006A within 30 days. The upgrade will be done fre
system software to version syngeo MI Applications 2006A within 30 days. The upgrade will be done fre
their website and mailed via certified mail return receipt.
r for Leksell Headring for treatment planning and patient set-up. An updated target positioner will be
ould be in contact with them to coordinate the replacement of the affected pumps with upgraded singl
bers listed are referenced on the PDB panel located in the equipment room. The letter also states the G
d instructions for cleaning and replacing the filters to protect the power supply from unnecessary accum
ther use the table in conjunction with a C-arm or any other heavy object until a service technician can
th regard to current patients. Consumers can contact 1-800-423-4087 for additional information or qu
vise them of the recall situation, and have them return their outstanding recalled stocks. If customers
r additional information, contact 866-359-1704.
support.
support.
em. An "Update" was mailed 03/04/2008 to identify additional ventilator serial numbers that also need
planting physicians to use in patient care and decisions regarding patient explants.
taminated, and repaired. Min-Mitter will rework all the devices returned. Each will have a new memor
a viable alternative for the customer and they wish to perform self-service, the customers will also be
ing that they have received the notification package. The accounts will be contacted by an Arjo repres
the unit in service until it could be replaced. Representatives will visit each consignee and replace un
to arrange for the replacement of the defective board.
ity to inspect and, if necessary, replace this power supply. Customers are asked to sign the letter ackn
1-800-825-5996.
For futher information please contack Andrea von Muller at 760-778-7323.
hich will open the circuit in case of overload on faulty circuits, and to exchange the low voltage cables
mailings were conducted through consignees (distributors as well as direct customers for the affected d
their customers to throw away any adapter that is being recalled. Technical Support will be available
may have a damaged percutaneous lead, please contact Thoratec Technical Services (800-456-1477) fo
support.
e may be found on the firm's website, www.thoratec.com, under Investor Relations/Press Releases.
hat once a permanent correction action is identified, service representatives will implement the correct
er the replacement part when available and dispose of the old part when the replacement is received.
engineers. The Healthcare Professionals are asked to contact the GE Healthcare Technical Support cen
ax or mail back the response form.
d information concerning this advisory can be found on St. Jude's website, www.sirn.com.
field safety notice in the event these brands of infusion pumps are still in use.
is not set to Auto-Analyze use the lower right soft key to select Analyze from the display screen... 3. A
s well as making provisions for alternative patient care measures.

country authorities and a copy of the report is also forwarded to the firm's distributor.
ssage Inquiry. Contact Client Support at 520-570-2252 for questions or additional information.
be return to the firm was also attached to the notification letter, which also provided the firm's custome
to physicians on 11/15/07. Physicians were asked to respond to both letters via an enclosed response
h each letter to ensure someone at the account acknowledges the information was received and unde
Users will be contacted by the recalling firm to schedule a software patch.

to return a confirmation of notification. For additional information, contact 1-877-371-4372.
s it becomes available.
ted software as part of a scheduled release. If further information or support is needed, customers sho
cause of the error. Make sure both breakers are in the "ON" position before starting up the unit each m
d 3) an Operator manual addendum Upon release of the countermeasure, the firm's Applications or Se
l be scheduling a visit to upgrade the application.
ift or landmark registration tools. Do not correct any perceived issues. A software fix is being validate
complete and return the enclosed Customer Reply Form, indicating that they have disseminated the in
rn the notification acknowledgement form is included with the letter.
2) and ask for Technical Support. As for a Long Term Solution, GE will provide a software update that w
ion, contact 1-800-348-9011.
owth Percentile calculations. You should make the appropriate selections in the Analysis Setup menu o
Rep will contact consignees in the future to schedule software updates to resolve the issue at no charge
pgrade all Offline Programming Modules using an enclosed CD.
ere attached to the letter. There was no software issued in response to this action. Since LP20 custom
t BD Customer Support Center if there are any additional questions. A software fix is being developed
nts were advised that they can request an analysis of existing patient records to determine whether th
version for the Agfa software. A Mandatory Service Bulletin will inform and assist affected account in re
ached list of serial numbers that will need to be updated with new software and to then email the a co
expected to be completed on July 24, 2008. Expected completion date of the Correction will be 12 mo
hone contact was provided at 1-800-522-7025.
e requested to make sure that all necessary physicians and personnel at their location are made aware
e software is updated. Direct any questions to the Remote Online Center, Field Engineer or the GE Cus
9 to schedule a time to upgrade their system to 6.70.6 P02 as soon as possible. The accounts were req
ines on-screen.
or the upgrade.
Siemens at 1-925-246-8407.
he problem, affected Products,and Short Term Recommendations .
for follow up.

ation of the field correction with the distributors for all countries. Non-responding consignees will be v
o use the 12 lead module, and to disable or disconnect the 16 lead connection.
Varian Medical Systems, Oncology Systems at 1-650-424-5731.
be completed and returned acknowledging the receipt of the Device Correction Notification.
lem is available on the Downloads page, http://www,mimvista.com/download.
for Use. EKOS contact number 1-888-356-7435.
MI No, 60745 & 60746), which enables users to scan in both Inferior to Superior and Superior to Inferio
olve the issue will be installed at no charge. Any questions were directed to the GE Customer Care Ce
or trailing blank characters (space bar) in the new branch name when customizing a Card IQ vessel an
ted with return proof of notification. Varian Medical can be contacted at 1-650-483-3153 for assistanc
anently resolve the issue will be installed at no charge. Any questions were directed to the GE Custom
, software patch to fix PETsyngo 4.x was released, and target date for the software patch to fix PETsyng
m suggested using the fixed field electron applicators and cutouts with these energies and field sizes.
will be contacted by telephone. A Mandatory Service Bulletin was deployed to correct the problem in t
n at the customer site. For assistance, contact GE Healthcare at 1-262-544-3894.
on to perform a system reset or reboot every day and stated that a software correction will be installed
Philips service personnel.
egin correcting the field.

o convert to alternative surgical techniques, if necessary. Customers are asked to fill out and return th
sion of software is available.

l be scheduling a visit to upgrade the application.
ware is available. User are asked to contact BD Customer Support Center at 1-877-232-8995 if they ha
reporting tools into the Siemens field update database.
call (800) 421-1968 and ask for the Regulatory Affairs Department.--A short term instruction included "
version is available.
e potential malfunction. The field modification will be immediately distributed and installed by the firm
which with software version 1.10 will lead to the inspiratory phase stopping. Ventilation will resume aft
the firm. AGFA Healthcare also provided a customer service contact number (877) 777-2432.
be issued by the end of June.
sion.
software patch
is under
ed
theAinformation
to their
staff, construction.
and indicating if they still have RenalSoft software and require an upgr
he customers that a Philips representative will be installing updated software at a future date.
of the software upgrade at no charge.
questions concerning this recall, please contact Phillips Medical at 1-800-722-9377, (option5: Diagnos
affected DR3000 systems.
completed within 45 days.

t 888-827-4265.
ns USA, Inc. at 1-925-246-8407 for assistance.
1-877-299-9052 for assistance.
this issue will be resolved in the next version of software.
FCO 70800067 will be issued to service representatives to install new software.
The accounts were requested to complete the enclosed customer reply form, supplying the software v
ntact Tech Support at 1-800-433-2009.
one of the following actions: Remove the affected AEDs from service or Remove and discard the shock
ontinue to use and monitor cords that are not exhibiting the described characteristics until replacemen
ment of the recalled pumps. Please contact the AN Device Call Center at 1-877-457-0249, Monday thr
uld be directed to Abbott Technical Support at 800-366-8020.
mation about the hazards associated with improper cleaning of the pumps and instructions for address
will not operate. If this problem develops, the account should stop using the irrigator and contact Micr
rection and Contact Information.
Maquet Inc. representative.
tification. The notification provides that customer with a toll-free number at (800) 989-7373ext.3234 o
mo CVS Customer Service at 1-800-521-2818.
-800-521-2818. Please direct questions to CVS Customers Service at 1-800-521-2818.
ly. The letter asked that the affected devices not be implanted and to contact their local representativ
63-514-4000.
informatio.
numbers that were missing from the first letter. The second letter was only mailed to the consignees o
User, Results of Investigation and Contact Details.
worked and replacement product or credit will be provided to the consignee. Records of contacts and of
8 or extension 4056.
using the Xeleris Volumetrix processing protocol to ensure proper registration. Local sales or service re
. Zoll's technical support department should be contacted at 1-800-348-9011 or +1-978-421-9460 to s

ntative would contact them within 60 days to schedule a corrective software upgrade free of charge. A
cted consoles. Please contact ABIOMED's Field Service at 1.800.554.8666, if you have any questions.
se direct questions to your CTS or call 954-927-2044, extension 604.
e product involved. The letter also gave recommendations and informed consignees in regard to a futur
print from the Viewer screen or to print the ECG once confirmed. The Viewer screen, however, does no
501-5748 in the U.S.
ck or to forward the software upgrade along with the end user letter enclosed and that the AED inform
software are not affected. The accounts were requested to complete the enclosed Customer Reply fo
nical Support or contact your local GE Healthcare Distributor.
their Varian Customer Support District or Regional Manager.

69-324-6644.
69-324-6644.
Questions or concerns should be directed to Terumo CVS Customer Service at 1-800-521-2818.

BOTT. Customers outside the US should contact their local hematology customer support representativ
Care Center at 800-437-1171. The accounts were requested to complete the enclosed customer reply f
er, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were requested to c
mpleted. They anticipate the software will be available in October 2008.
contact Beckman Coulter, Inc. by telephone at 714-993-5321.

roscopy time when the affected system is in use.
71. The accounts were requested to complete the enclosed customer reply form, supplying the worksta
08. For further information, please contact GE Healthcare at 262-544-3894.
ngements to update the programmer 2090.
on 5: Radiation Therapy, option 3: Oncology) or to your local Philips Healthcare office.
the spine with respect to the posterior marking in the image." The error should be fixed within certain
orama(s) in their facility. This will be done at no cost to the customer.
Technical Support at 1-800-526-1247.
at Customer.Advocacy@cardinalhealth.com.
341-6968.
a service representative within the next six weeks to schedule the update. Any questions were directe
Customer Care Center at 800-437-1171. The accounts were requested to complete the enclosed custo
ction becomes available. If further assistance is needed, customers are to contact the Philips Custome
oblem in the software. If you have questions, please contact Agfa Healthcare at 1-800-581-2432 prom
s, customers are to contact the firm at 972-410-7100.
l Health-NeuroCare. Further information can be obtained by calling 1-800-356-0007 ext 2191 or fax to
tryker notifies customers. If there are questions, customers should contact Stryker at 972-410-7100.
s a prerequisite for the following safety related hotfixes: VB20G_HF4 and VB30A_HF26.
nd install a software upgrade on the affected system(s) at no cost to the customer. Lastly, the letter pr
o your local Philips representative or Philips Customer Care Center (1-800-722-9377), option 5: Other I
ne at 330-425-1313.
Drager Medical, Inc. by calling 1-800-543-5047 (press "1" at the prompt and then press "2349#"). Dir
res should be performed and all affected personnel should be informed immediately. The firm is track
31) 84-2056.
at 888-778-3375 or 905-479-1249, select option 1. The accounts was requested to complete the enclos
line Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were reque
ptime Service Senter if they have any questions.
at 425-487-7602.
when it becomes available.
t your local Philips representative: Customer Care Center (1-800-722-9377, option 5: Diagnostic Imagin
call should be carried out to the user level and return the enclosed response form as soon as possible.
chi Service Rep. will be contacting each customer and making arrangements to set up a convenient tim
a FAX-Back, that the information was received and understood was requested from the sites.
s of the product, when used outside of this intended use, have not been established." They were instru
informatio.
2. Upon receipt of the form, a Stryker Navigation Field Service Rep would contact them to schedule the
ng customers and actions to be taken. Customers are to visually inspect the affected cords, complete
equency of follow-up is recommended. For additional information or assistance, please contact your loc
vice Correction, please contact your local Philips representative.
8804 or via email at clinicaltechnicalservices@cyberonics.com.
stance
line at
o
requested
to 224-430-1522.
complete the enclosed reply form and return it to Hospira by fax at 1-262-577-6921, ind
return it to Medtronics.
formation to arrange for return of the units.

ower Cords, for questions regarding the recall notice or to report any issues with the affected product,
s areremain
scheduled.
Customers
with questions
contact the firm at 800-442-1142 between 6 am an
may
in service
until a replacement
is should
received.
n the interim, hospitals should continue to use normally functioning devices.
contact, and 3) if monitoring, be prepared to switch back to the primary ECG that was initially obtaine
. For questions regarding this correction please contact (408) 982-4800, or fax (408) 982-4863.
ill affix a label to the device on-site to remind operators how to recover from loss of X-ray from SID fail
ressed mail, fax or email.
y customer/user_x001D_ section of the Urgent Medical Device Recall Notification.

and replacement of affected devices.
Recall Center immediately.
entative to schedule an appointment.
ignees returning devices to Philips for routine recalibration will receive free replacement. All CPR mete
erness Medical Technical Service at 1-877-441-7440 and select option 2 from the phone prompt and a
n the
contextMedical.
of other diagnostic tests.
ed
to Smiths
mers can contact Ikaria Customer Care at 1-877-566-9466.
addressed Background information, Why are we communicating, What You Should Do and Questions.
nt for SpO2 was enclosed with the letter.
irected to Spacelabs Medical's Technical Support at 1-800-522-7025, and 1-425-657-7200 x5089 for th
cal Support at 1-800-558-7044.
a Philips rep should be contacted. For further information or support concerning the issue, a Philips re
ax to the firm. Consignees were requested to notify customers.Consignees may contact the firm at 503
hould document a request to load the software.
or replacement product with the software upgrade. For international distribution, the hospital will be in
will be maintained. Affected products received by Teleflex Medical will be reworked with software upgr
Sales Representative will install a software upgrade to fix this issue. Additional questions should be dir
further information please contact Smiths Medical at 651-628-7280.
E Healthcare representative to schedule the software upgrade.
at 1-800-722-9377.
pt of the task and grant permission to load the required software.

CO 764 00 551 053.
udy first, before browsing through other documents. A software update that prevents the problem from
software.
nce they received and understood the notice. Sites that do not return the card will be contacted by ph
y at 781-557-3000.
mer reply form and fax the completed form to 847-620-2780. Any questions should be directed to their
tomer reply form. Questions were to be directed to Aaron Ybarra, X-ray Product Manager at 800-421-1
affected units. The new version of the corrected software is Guideline 4000 version 1.41. Questions sh
ted towards TomoTherapy Customer Interaction Center by e-mail or telephone.
this time. When the client decides to accept the correction a new task will be created to initiate the p
ware-Update for each affected version, except for version VB20. All customers on VB20 will be upgrad
sages in SoftPath. Client was asked to acknowledge receipt of the task and grant permission to load th
number. Client was asked to acknowledge receipt of the task and grant permission to load the require
closing the pump door. Follow-up phone calls were made to coordinate an upgrade to all affected pum
ts before continuing the use of the device Edwards first provided some of this information to consignee
power-on before use; if the device does not power on, replace the batteries with a different brand of si
e requested to complete the enclosed acknowledgement form and fax it back to Haemoscope at 847-5
1-471-2147 or via email jorges@aicompanies.com. The attached response forms were to be complete
uration update to correct the CTDI display to all affected systems. Questions should be directed to the
ts at 1-800-441-4100. The customers were requested to contact Hospira Advanced Knowledge Center
rica: soporte.al@varian.com; Internet: Oncology Systems - www.myvarian.com; Varian Medical System
vices at 800-552-0138 to schedule a time to have their equipment upgraded.

evice malfunction. The accounts were requested to complete the Customer Response Form online, usi
y suspected incidents related to this issue to CardioCommand Customer Service at 1-800-231-6370. A
pection and replacement of defective parts. Contact Terumo CVS Customer Service at 1-800-521-2818
and/or servicing will be contacted directly to arrange for the return of their device(s). Additionally, sal
e hardware exchange. Questions regarding this issue should be directed to the local service support p
tative or call Customer Service for any additional concerns or questions regarding this notice.
onse form was also included for completion and return to the firm. Customers can contact the firm if t
be serviced by Philips Invivo. For further information or support concerning this issue, customers are t
3) for a Return Authorization (RA) or send an email to endo.andreturns@smith-nephew.com. For ques
mation at USA and Canada: 1-888-827- 4265 or Europe +41-41-749-8844.
customersvalue
with is
ansignificantly
explanationdifferent
of the problem
identified and
an action
be taken.
displayed
from expectations
based
on thetoclinical
situatioin, the user sho
The
Business
Reply
card
is
to
be
completed
and
returned
to
Abbott.
Questions
or comments are to be d
edisplayed
glucose and
lactate
sensors.
value is significantly different from expectations based on the clinical situatioin, the user sho
act Information.
rd this
letter
immediately
to allTermination
customers who
the affected
products,
and
gather proof
of not
be
aware
if performing
Manual
withreceived
Blood Return,
air detection
is not
provided,
and comple
nderstanding of the Safety Notice.
hines
at the
customers'
facilities.
g to the
attached
instructions,
and to complete and return the Customer Reply form via fax to 1-800-77
e treating. The letter included "Caution" stickers that were to be applied to the CDI system operators m
clude the FlexMap Check and complete and return the Important Notice Confirmation of Receipt via Fa
eers to confirm their receipt of the documentation. The Technical Notes also discussed image visualiza
ed to the GE Service Center at 800-766-6062.
t may potentially be affected by the issue. For questions, concerns, and requests for upgrade, email su
the Safety Notice from Elekta IMPAC Software in their product related documentation until further notic
http://www.MyVarian.com. Any questions regarding this Product Notification letter, contact Varian Med
the affected product. The customers were requested to contact Hospira Advanced Knowledge Center
software in affected monitors. The software upgrade will be provided free of charge.
regarding this notice.
to Orthoralix DDE User Manual that explains how to resend the images. If that does not resolve the iss
Systems-www.myvarian.com; Varian Medical Systems -www.varian.com; or your local Varian Customer
tion, then it is recommended that the sample files be re-analyzed. If customers need more informatio
opy with the letter. It was also posted to the customer support site. If further clarification is needed, c
ions should call 1-800-521-2818. Monday- Friday 8 am- 6 pm.
l appropriate personnel should be notified of the correction notice. For future reference, this document
oftware version is required. Contact the Call Center at 800-437-1171.
firm receipt of the Safety Notice.

m software free of charge. Philips will contact customers to implement the FCO. Further information o
be receiving release notes as part of their correction informing them of the changes and corrections to
Quality System documentation. If they forwarded the affected product listed above to another laborato
concerns
are directed J12
to call
Diagnostics
at 1-800-428-2366,
available
ttn:
MOD Coordinator
andRoche
forward
a copy of Technical
this noticeSupport
to any other
facility personnel.
Note:24-hou
The c
ware upgrade kit. The letter also states that affected units can remain in service until the software ha
America and Asia at 702-992-5002 or Europe and Africa +44 (0)1293 654401, Attn: Elekta OIS Su[pport
pdate to their monitors.
pected to be resolved with XiO Release 4.50.00.
m of the updated software available to correct the problem. If you have any questions, please call 314
nd there is no charge for the software upgrade.

Regional Manager. The letter also provides Varian Oncology Help desk contact information 1-888-827-
porte.al@varian.com; Internet: Oncology Systems customer site - www.myvarian.com and Varian Medic
opriate personnel of the content of the letter. If further clarification is needed, customers are to conta
questions about this corrective action program, please contact Spacelabs Medical at 1-800-522-7025 an
gineering or Biomedical group at their facility. Customers are also to complete and return the attached
ade, they should contact Technical Support at 1-800-736-0600 Opt 4.
r local service support person. The information in the letter should be shared with all personnel within
at a software enhancement is currently available. Acknowledgment via FAX-Back was requested from t
866 - 531 -7365. Questions should be directed to Technical Support Monday through Friday from 8:00 a
n of affected product. For further questions contact your local Medtronic AF Solutions representative.
. The letter should be included with the Owner Manual of the system in the chapter for "Safety Adviso
n their syngo RT Therapist 4.1 System Owner Manual chapter "Safety Advisory Letters" where it should
re April 2011. Previous versions of the software will begin to receive corrected software June 2011. Th
egarding this notice are directed to Support at 802-658-1955.
e USA or +011 (203)697-6488 for International customers.

any questions concerning this notification contact your local service representative.
ers should have been contacted to schedule a time for the installation. Questions were to be directed
ntact Service Dispatch number at 1-800-864-1672 for questions regarding this detail.
in order to revise the language on the cycle printout and the display screen warning of a disrupted cyc
figure macros as necessary.
d software as soon as possible. Questions can be directed to 800-426-6331, ext 215.
each computer on which LOGIX OE software is installed. The customers were also requested to comple
al Services at 1-800-595-9709.
r reply form and fax it to Baxter at the number provided on the form. Any questions regarding the com
ion of the appropriate User Manual. For questions contact your local Elekta representative.
ce also informed the consignees they would be contacted when a solution was available.
he applicable country. The letter should be distributed to all users affected by the issue at the custom
utilize the software.
20-2780. Any questions should be directed to their GE Service Representative or the GE Help desk at 8
which will permanently fix the issue and prevent it from occurring. Customers are to contact the Regul
entative will update the systems.
ers are to contact their local Elekta representative. Once the installation of Service Pack 2 has taken p
in March 2011.
1-800-722-9377 for questions concerning this notice.
ates that Philips Medical will provide a solution that will fix the issue and the notification lists contact n
s Healthcare office should be contacted at 440-483-3000.
0.8 and higher.
d software issues free-of-charge, through a Field Change Order. Customers were instructed to contact t
ave processed and displayed on the LATITUDE website.

estions contact your local Elekta representative.
letter for customers to complete and return. Contact Technical Product Support at 1-800-627-7867 fo
xter informed the accounts that they would be notified when the new release of the Colleague Volumet
ons provided in theField Action Notes have been followed and that the necessary component replacem
d the Physician and patient elect to replace the affected implanted device.
the customer''s Operator''s Manual.
ment guidelines. Subsequent follow-up visits should continue to monitor for evidence of premature bat
fication performed at their convenience. .

the customer''s Operator''s Manual.
etrieved. .
r, and within 30 days if it has not displayed the Defib Comm error by fax or mail. A loaner PIC 50 will th
s on how to return their unit for correction.
days of onboard storage. .
ew Worklist is loaded and started. 5) After the Worklist is continued, or loaded and started, during the a
r with a suitable substitute rental ventilator at no charge. The field action will involve the upgrade of al
the neurostimulator.
enting the potential for erroneous results.
orrections were verified as having been completed by 3/10/2006.
e contacting the customer in order to schedule a device correction which should address the problem.
with the notification and users are requested to return the customer receipt verification via fax. .
sion. At that time the mitigation provided in the letter will be reviewed with the customer.
ess both issues] will be released on or before 2/27/2006, and this software upgrade will be performed b
personnel during each customer''s next scheduled PM. The Device Notification Letter also instructs the
led for completion by 3/1/2005.
r existing packs in the same shipping box.
during mid-life have several months, and in most cases more than one year of remaining battery volta
during mid-life have several months, and in most cases more than one year of remaining battery volta
accounting form.
ir Solitaire LP4532 laser and/or Intregre Duo LP1RG is up to the manufacturers specifications and is in
ir Solitaire LP4532 laser and/or Intregre Duo LP1RG is up to the manufacturers specifications and is in
odes, the user was requested to submit the pump to their service facility. Failure code 199 may also oc
e affected unit. The accounts were also instructed to respond to the notification within 30 days by fax
r. Any questions regarding the Important Safety Notice were directed to their service representative o
of the back panel of the device. In addition the letter includes a response form, the firm's contact infor
ed is instructing patients, sleep labs, and hospitals to continue using the device, placing it on a hard c
ze the separation between programming of the main and auxiliary consoles. Questions regarding this
the firm can send letters to those customers.

Notification will begin in Sept 2007 and will be made by personal visits to each consignee.
ffairs Department.
ert notification has been received and that the staff members responsible for operating and maintainin
d to be correct when the MAP is accurate. The problem is in the transfer of the MAP between the bedsid
mplete in order to verify receipt of the recall letter and to fax back to the recalling firm.
representative.
y Data Disk (ADD #5465), and were instructed to load it and recalibrate these assays, if necessary.
c Consignees will have product corrected by VIASYS service personnel. Self address postage paid enve
e form is included for consignees to return to recalling firm.
Department. Customers were also instructed to distribute this information to all users of the product a
cation are made aware of the issues and understand the risk mitigation provided. A software patch to
cheduled service visit.
system-Customer Care Contact telephone 1-800-722-9377).
notify their sales representative if any of the conditions mentioned in the letter occurred. The accounts
n to all users of the product and also with the Bio-medical Department at their facility.
) 421-1968 and ask for the Regulatory Affairs Department.
upgrade will be done free of charge.
upgrade will be done free of charge.
arget positioner will be provided to the customers to correct the problem, estimated to be available in
mps with upgraded single channel pumps or non-upgraded triple channel pumps, if available. Any ques
e letter also states the GE Healthcare Resolution Plan, includes correcting the condition, and contact In
from unnecessary accumulation of debris. Contact firm at 1-888-MERETEK for assistance.
service technician can permanently remove the battery from the control box according to the enclose
tional information or questions.
ed stocks. If customers have any questions, they were instructed to contact at 858-481-8485.
numbers that also need correction.
will have a new memory chip installed, be re-calibrated, retested, and have a new battery installed if r
e customers will also be provided with a Service Bulletin to provide instruction on replacement of the re
tacted by an Arjo representative within a week to arrange the replacement of the battery pack and cor
onsignee and replace units.
d to sign the letter acknowledging receipt of this letter upon completion of the work by the Field Servic
the low voltage cables that directly connect the medical power supply from 1.5 mm2 to 2.5 mm2 thic
omers for the affected devices).

upport will be available for customer questions and technical questions and to ensure each unit is upg
vices (800-456-1477) for assistance.
ons/Press Releases.
l implement the correction. For assistance, contact GE Healthcare at 1-800-345-2700.
eplacement is received.
e Technical Support center at 1-800-558-7044.
.sirn.com.
he display screen... 3. All other buttons are labeled outside the display screen." If you have any ques
nal information.
vided the firm's customer service number: (877) 777-2432.

a an enclosed response card, acknowledging receipt of the notification. Additional information will be
was received and understood. If a FAX Back form is not received, the account will be contacted by tele
77-371-4372.
needed, customers should contact the Telehealth Customer Service Line at 1-866-246-7316.
rting up the unit each morning and before giving treatment.
firm's Applications or Servcie personnel shall perform the corrective action as identified in the Service P
ware fix is being validated and will be available soon.
have disseminated the information to their staff and home patients. Any questions were directed to Ba
a software update that will rectify the issue as soon as an upgrade is available.
Analysis Setup menu on your system.".
ve the issue at no charge; and contact information.
ion. Since LP20 customers may purchase a software program allowing them to update their defibrillat
e fix is being developed in version 6.0 and a free maintenance release with no product enhancments (
to determine whether they have been affected by the PFILS issue, by submitting a non-critical Technica
st affected account in removing JAVA 1.6 if it has been applied and turning off the automatic updates v
d to then email the a contact at the firm once updates have been completed. All updates must be com
Correction will be 12 months from July, 2008.
ocation are made aware of the problem and the recommended actions provided. A software patch to p
d Engineer or the GE Customer Care Center at 800-437-1171. The accounts were requested to comple
. The accounts were requested to complete the enclosed customer reply form, supplying the workstati
ing consignees will be visited or called by telephone for follow up.
n Notification.
r and Superior to Inferior directions and have no mismap between the functional and anatomical image
e GE Customer Care Center at 800-437-1171.
izing a Card IQ vessel analysis protocol until the new software version can be installed. A software pat
-483-3153 for assistance.

ected to the GE Customer Care Center at 800-437-1171.
ware patch to fix PETsyngo 3.2 and 3.4 is the end of November 2007.
nergies and field sizes. Siemens will release a new control console software in 2008 for free-of-charge,
correct the problem in the software.
orrection will be installed at their site at no cost.
d to fill out and return the acknowledgement form.
-877-232-8995 if they have any additional questions.
rm instruction included "Avoid using the Freeze Key when performing dynamic image acquisitions".
and installed by the firm's Service as soon as it is available.
ntilation will resume after approximately 5 seconds. The device will generate a Paw Measurement INOP
877) 777-2432.
are and require an upgrade. Any questions were directed to Baxter Global Technical Services at 1-800
t a future date.
9377, (option5: Diagnostic Imaging, option 5:NM).
upplying the software version number, and fax it back to 847-277-5240.
e and discard the shock button cover (see enclosed illustration). Enclosed with the letter is an illustra
eristics until replacement cords are sent to their facility. Hospira will contact customers to schedule rep
7-457-0249, Monday through Friday between the hours of 8:30 am and 5:00 pm Eastern Standard Tim
instructions for addressing damaged battery messages. Customers were instructed to complete the a
rigator and contact Micromedical Technologies, Inc. at 1-217-483-2122 or via e-mail at mmtinfo@micro
00) 989-7373ext.3234 or call collect at (513) 719-3234 to reach CSZ representative between the hours
their local representative for pick-up and return. The firm will replace the affected devices. Please dir
iled to the consignees of the additional 700 units.
cords of contacts and of destruction or rework will be maintained. Questions are directed to the compa
Local sales or service reps should be contacted for further information regarding the notification.
or +1-978-421-9460 to schedule the return of affected devices with the defect for replacement of the s
pgrade free of charge. Any questions were directed to contact Siemens Medical Solutions USA, Inc. at 1
ou have any questions.
nees in regard to a future update to the LIA software for EnTrust devices.
creen, however, does not allow the user to print batches of reports as does the Index screen. Questions
and that the AED information text file generated by the update software must be returned to the firm.
osed Customer Reply form, indicating the instrument serial number and software version for each mac
-800-521-2818.
er support representative.
closed customer reply form, supplying the workstation software or build number, and fax the complete
nts were requested to complete the enclosed customer reply form, supplying the workstation software
m, supplying the workstation software or build number, and fax the completed form to 414-918-4653.
d be fixed within certain upgrade and installation activities on the affected software.
y questions were directed to BrainLab at 1-800-597-5911. ***.
plete the enclosed customer reply form, supplying the workstation software or build number, and fax th
act the Philips Customer Care Center at 1-800-722-9377.
at 1-800-581-2432 prompts 1, 3 and then 2 for CR Support.
0007 ext 2191 or fax to 1-877-244-3805.
yker at 972-410-7100.
mer. Lastly, the letter provides a telephone # to the firm's Applications Helpline: 1-877-228-2777, whic
-9377), option 5: Other Imaging Systems, option 1: CT or to your local Philips Healthcare office.
hen press "2349#"). Direct questions regarding updating your device when the new software is availa
iately. The firm is tracking responses via return cards and completion protocol.
d to complete the enclosed customer reply form, supplying the workstation software or build number, a
The accounts were requested to complete the enclosed customer reply form, supplying the workstation
ion 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: Oncology) or to your local Philips Hea
orm as soon as possible. If there are any questions, they are advised to contact David Salzberg at (800
o set up a convenient time to come out and perform a software upgrade. Lastly, the letter provides a t
rom the sites.
shed." They were instructed to apply the stickers to any existing manuals and or at each point of use,
act them to schedule the repair of their equipment. All U.S. units were corrected by 10/30/09.
ffected cords, complete the Customer Reply Power Cord Order Form, and follow the instructions to disp
, please contact your local Medtronic Representative or Medtronic Technical Services at 800-505-4636.
at 1-262-577-6921, indicating the amount of product placed on hold for return, if they further distribu
th the affected product, please contact the Smiths Medical Technical Service Department at 1-800-558
-1142 between 6 am and 4 pm Pacific Time, Monday - Friday.
hat was initially obtained for a given patient if other leads are lost. Customers will be contacted and as
x (408) 982-4863.
ss of X-ray from SID failure. Consignees may contact GE at 800 437-1171, option 4.
lacement. All CPR meters will be replaced with re-designed meters when they become available.
he phone prompt and a representative will confirm the number of kits discarded from your inventory an
ould Do and Questions.
5-657-7200 x5089 for those customers outside of the US.
ng the issue, a Philips rep should be contacted at 800-722-9377.

contact the firm at 503 537-3602.
n, the hospital will be informed of this issue through Bard affiliate and Notified Body Bard Europe and m
rked with software upgrade and placed back into distribution. Consignees will either receive a software
l questions should be directed to the firm's Customer Service at (800)624-4422 or (408)754-2039.
events the problem from occurring is currently under development for all affected releases and will be
will be contacted by phone.
ould be directed to their GE Service Representative or the GE Help desk at 888-778-3375.
t Manager at 800-421-1968, ext. 2492.
rsion 1.41. Questions should be directed to Jason Moyer, product manager or Keri Seitz, recall coordina
created to initiate the patch using the Task Management System.

s on VB20 will be upgraded.
ant permission to load the required software correction.
ssion to load the required software correction.
grade to all affected pumps. Questions or concerns should be directed to Ross Kurz at 720-531-4933.
nformation to consignees in a _x001C_Field Safety Notice_x001D_ on March 16, 2009. On January 11, 2
h a different brand of size C batteries and verify that the device will power-on before use; and to place
o Haemoscope at 847-588-0455. Any questions were directed to 1-800-438-2834.
ms were to be completed and returned as instructed.
hould be directed to the contact numbers provided in the letter.
nced Knowledge Center at 1-800-241-4002 for technical assistance. The accounts were also requested
; Varian Medical Systems -www.varian.com.
sponse Form online, using the enclosed card's instructions. Questions were directed to the ArjoHuntleig
e at 1-800-231-6370. Also questions or comments should be directed to CardioCommand Customer Se
vice at 1-800-521-2818 for questions regarding this notice.
vice(s). Additionally, sales specialists were instructed to examine each customer's inventory for those
e local service support person.

ing this notice.
can contact the firm if they have any questions.
s issue, customers are to contact Philips Invivo Customer Support at (877)-468-4861 or their local Philip
-nephew.com. For questions call 405-917-8556.
l situatioin, the user should verify the accuracy by independent means before treating. The letter inclu
or comments are to be directed to Abbott Point of Care Technical Support at 800-366-8020, Option 1.
l situatioin, the user should verify the accuracy by independent means before treating. The letter inclu
and
gather proof
of notification.
For further
questions
concerning
contact
Medtronic
ot
provided,
and complete
and return
the Customer
Reply
Form viathis
faxnotification,
to: Regulatory
Affairs
at 1-866-C
form via fax to 1-800-777-0051 or email to QAGCO@abbott.com.

CDI system operators manual.
mation of Receipt via Fax to: Field Support Administration, Elekta Limited, Linac House, Fleming Way Cr
scussed image visualization requirements and listed recommendations.
ts for upgrade, email support@impac.com or call. The letter provided consignees with a complete list
tation until further notice. If customers have any questions, they should contact their responsible SIEM
tter, contact Varian Medical Systems Help desk at 1-888-827-4265 for USA and Canada and +4141749
nced Knowledge Center at 1-800-241-4002, option 4, for technical assistance.
does not resolve the issue, users were requested to contact Gendex Technical Support at 1-800-323-8
ur local Varian Customer Support District or Regional Manager.
s need more information they should contact the Customer Support Center at 877-232-8995.
clarification is needed, customers are to contact their local Varian Customer Support District or Region
eference, this document will be posted to the Varian customer support website: http://www.MyVarian.c
O. Further information or support concerning this issue can be obtained by contacting your local Philips
anges and corrections to the software. The new software will be installed on affected units by Philips Fi
bove to another laboratory, they were asked to provide a copy of this letter to them.
-2366,
available
7 dayscan
a week.
personnel.
Note:24-hours,
The customer
request that Hill-Rom technicians complete the software upgrade.
ce until the software has been updated.
Attn: Elekta OIS Su[pport and/or scan and email to: support@impact.com, europe.support@impact.com
estions, please call 314-993-0003 or toll free 800-878-4267.
information 1-888-827-4265 for USA and Canada and +41417498844 for Europe.
n.com and Varian Medical Systems public site-www.varian.com.

customers are to contact their local Varian Customer Support District or Regional Manager.
cal at 1-800-522-7025 and select 2 for Technical Support, or outside the United States 1-425-657-7200
and return the attached reply form via fax or e-mail to TAMS as proof of notification. Questions pertain
with all personnel within the organization who need to be aware.
ck was requested from the sites. Questions regarding the issue should be directed to customers' local
rough Friday from 8:00 am to 8:00 pm Eastern Time.
lutions representative.
apter for "Safety Advisory Letters" until an update is provided.

Letters" where it should remain.
software June 2011. The software will be provided free of charge. Questions related to the letter shou
ons were to be directed to the local service support person.
arning of a disrupted cycle. It also states that a STERIS Service Representative will be contacting each
so requested to complete the attached customer reply form and fax it to Baxter at the number provide
stions regarding the communication were directed to Baxter's Medical Information Services at 1-800-4
presentative.
available.
the issue at the customer's organization.
or the GE Help desk at 888-778-3375.
are to contact the Regulatory Affairs and Operations Manager if they have any questions.
rvice Pack 2 has taken place, the notices listed in Table 1 of the letter will no longer be applicable and
otification lists contact names; telephone numbers; and E-mail addresses which the customer can cont
e instructed to contact their Philips representative or local Philips Healthcare Office for further informat
rt at 1-800-627-7867 for questions regarding this notice.
f the Colleague Volumetric Infusion Pump Operator''s Manual is available. Any questions were directed
ry component replacements have been completed. The firm anticipates that the necesary corrective a
dence of premature battery depletion.
il. A loaner PIC 50 will then be sent to the consignee with instructions on how to return their unit for co
and started, during the acquistion of a tube, the Pause and Rotate Button is selected. 6) The carousel P
nvolve the upgrade of all affected devices with a new flow valve assembly. All US and International unit
d address the problem.
rification via fax. .
e customer.
ade will be performed by HMSA''s service personnel during each customer''s next scheduled PM. The
Letter also instructs the customers to call their Field Service Representatives or the HMSA Application
remaining battery voltage and capacity, which allows the devices in this pattern to continue to provide
remaining battery voltage and capacity, which allows the devices in this pattern to continue to provide
specifications and is in good operating order.
specifications and is in good operating order.
re code 199 may also occur and requires reconfiguration of the pump settings by the user's biomedica
n within 30 days by fax or mail, or by calling Welch Allyn - MRL Technical Support at 1-800-462-0777, to
ervice representative or Siemens office at: 1-800-888-7436 (USA).
, the firm's contact information, and indicates that the firm will exchange the recalled defibrillator with
e, placing it on a hard clean surface, with a clear area around the device. ResMed intends to replace t
Questions regarding this matter may be directed to Mallinckrodt's Product Monitoring Department at 1-
h consignee.
perating and maintaining the analyzer(s) on-site have been informed of this situation and that the nec
MAP between the bedside monitor and the Vigilance II. Customers are also advised that if they have t
assays, if necessary.
dress postage paid envelopes will be provided with notifications to aid in effectiveness checks.
ll users of the product and also with the Bio-medical Department at their facility.
ed. A software patch to permanently resolve the issue will be installed at no charge when it becomes a
occurred. The accounts were requested to complete and return via fax at 847-689-9101, the enclosed
mated to be available in September 2007. Any questions were directed to their local BrainLAB Custom
s, if available. Any questions were directed to Baxter's Medication Delivery Services at 1-800-843-7867
condition, and contact Information.

assistance.
according to the enclosed Service Manual Amendment No. 1. Stille will make a permanent correction t
t 858-481-8485.
new battery installed if required. Min-Mitter will provide a new one year warranty.
on replacement of the rear case assembly.

he battery pack and corresponding connectors (male part/plug) on the lift and battery charger.
work by the Field Service Engineer.
5 mm2 to 2.5 mm2 thickness to withstand the full 20 amp current in case of a failure. Any questions w
ensure each unit is upgraded.
." If you have any question contact technical support at 1-800-442-1142 - option 5 or visit the web sit
onal information will be posted at www.VNStherapy.com.
will be contacted by telephone. Contact AGFA at 1-877-777-2432, prompts 1, 2, 1.
866-246-7316.
dentified in the Service Pack (A) Installation Instructions. Finally, upon release of the next software rev
ions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 1.
o update their defibrillator software, the letter recommends confirming Auto Analyze Setup Option is s
product enhancments (version 5.0.3).

g a non-critical Technical Support Request on the GE Centricity Perinatal Web site: http://www.gehealth
he automatic updates via the JAVA Plug-in Control Panel.
All updates must be completed by August 31, 2008.
d. A software patch to permanently resolve the issue will be installed at no charge when it becomes av
ere requested to complete the enclosed customer reply form, supplying the workstation software or bu
supplying the workstation software or build number, and fax it back to 847-277-5240.
al and anatomical images.
nstalled. A software patch to permanently resolve the issue will be installed at no charge. Any questio
2008 for free-of-charge, that will limit the use of the DEVA to energies 6MeV and above, while allowing
image acquisitions".
Paw Measurement INOP alarm. Until the new software is available, customers are being instructed to a
hnical Services at 1-800-553-6898, option 4.
h the letter is an illustration providing instructions for removal of the auto shock button cover. Custom
stomers to schedule replacement. Customers are to complete and return the attached Reply Form. Q
m Eastern Standard Time (EST). An AN representative will work with you to arrange service or replacem
ucted to complete the attached Customer Reply Form acknowledging receipt of the letter and fax it to
-mail at mmtinfo@micromedical.com to report the problem for repair of the unit.
ative between the hours of 8:30 a.m. until 4:30 P.M. Monday through Friday EST. Once the customer sh
cted devices. Please direct questions to your local Sales representative or Boston Scientific Corporation
e directed to the company at 1-866-246-6990.
ng the notification.
for replacement of the suspect component.

Solutions USA, Inc. at 1-800-767-2313 (USA) for assistance. The accounts were requested to complet
Index screen. Questions about this matter are being directed to the local Agfa HealthCare representat
be returned to the firm. The firm will visit the locations of individual national account customers and in
are version for each machine at the site, and if they would be requesting Baxter Technical Services to u
er, and fax the completed form to 847-939-1479.
he workstation software or build number, and fax the completed form to 414-918-4653. For further inf
form to 414-918-4653.
build number, and fax the completed form to 414-918-4653.
e: 1-877-228-2777, which the customer can use to obtain additional information, if desired.
Healthcare office.
e new software is available, contact Drager Service Technical Support at 1-800-543-5047 (press "4" at
ware or build number, and fax it back to 905-305-0046 to schedule the software upgrade.
upplying the workstation software or build number, and fax the completed form to 847-939-1479.
to your local Philips Healthcare office.
David Salzberg at (800) 576-1266.

y, the letter provides a toll-free telephone # to the firm's 'Customer Service Center: 1-800-800-4925, w
or at each point of use, and to instruct all users about the notification. The accounts were also reques
d by 10/30/09.
the instructions to dispose of affected cords. Further information or support concerning this issue can
rvices at 800-505-4636.
, if they further distributed the product and if they notified their retail customers. For medical inquiries
epartment at 1-800-558-2345.
will be contacted and assisted by Philips field service engineers to install the software upgrade which c
become available.
d from your inventory and arrange for replacement product to be sent to you.
Body Bard Europe and managed according to the requirement. If there are questions or assistance is
either receive a software upgrade on site by a third party or replacement product with the software up
2 or (408)754-2039.
ed releases and will be available in approximately three months. Consignees will be notified when the
-778-3375.
Keri Seitz, recall coordinator at 207-666-8190.
Kurz at 720-531-4933.
, 2009. On January 11, 2010, Edwards provided an _x001C_Urgent Product Recall_x001D_ letter to con
before use; and to place a copy of the letter with each operator's manual for the InfusOR and Mini-Infus
nts were also requested to complete the attached Reply Form and return it to Hospira via fax at 1-888-
ected to the ArjoHuntleigh at 1-800-323-1245, ext 57985.
oCommand Customer Service.
er's inventory for those device(s) that may potentially have the jumper-wire and to perform a stand-by
-4861 or their local Philips Invivo representative.
treating. The letter included "Caution" stickers that were to be applied to the CDI system operatros ma
0-366-8020, Option 1.
treating. The letter included "Caution" stickers that were to be applied to the CDI system operatros ma
tion,
contact
Medtronic
Cardiovascular
Technical Support
877-526-7890
or Medtronic Sales Represen
ulatory
Affairs
at 1-866-447-4471
or 303-222-6916,
or byat
email
to: GRPRegulatory.Affairs@us.gambro.c
House, Fleming Way Crawley, West Sussex, RH10 9RR UK +44 (0)1293 654401.
ees with a complete list of contact information..

ct their responsible SIEMENS Service Engineer or Application Specialist.
d Canada and +41417498844 for Europe.
Support at 1-800-323-8029. Customers were asked to complete and return the enclosed Acknowledge
877-232-8995.
upport District or Regional Manager.
: http://www.MyVarian.com. For further clarification, contact your local Varian Customer Support Distri
tacting your local Philips representative. The Field Service Engineers began software implementation th
ected units by Philips Field Service Engineers.
e the software upgrade.
pe.support@impact.com or by mail; and distribute this notice to any all users of IMPAC software at the
nal Manager.
States 1-425-657-7200 x5089.
ation. Questions pertaining to the letter should be directed to 800-421-1968 or customers' local Toshib
cted to customers' local Agfa HealthCare Service at 877-777-2432.
elated to the letter should be directed to the Regulatory Affairs Department at 800-421-1968.
will be contacting each facility in order to schedule installation of the new software. The notification al
er at the number provided on the form. Any questions regarding the communication were directed to B
tion Services at 1-800-422-2751.
questions.
nger be applicable and should be removed from the User Manual. Customers should direct their quest
h the customer can contact for further information concerning this device issue, or customer support as
ffice for further information or support for this issue. For North America and Canada customers were in
questions were directed to Baxter''s Medication Delivery Services at 1-800-843-7867.
he necesary corrective action will be completed by 7/1/2006.
o return their unit for correction.
ected. 6) The carousel Pauses but does not Rotate. 7) When the Start/Continue or Restart button is sele
US and International units are being recalled to the factory in Carlsbad, California. The rework will be co
next scheduled PM. The Device Notification Letter also instructs the customers to call their Field Service
or the HMSA Applications Helpline if they have any questions about the notice, or if any additional prob
rn to continue to provide brady and LV pacing and maximum energy shocks. However, if ERI or EOL is
rn to continue to provide brady and LV pacing and maximum energy shocks. However, if ERI or EOL is
by the user's biomedical services organization. Any questions were directed to Baxter Global Technica
rt at 1-800-462-0777, to schedule their PIC 50 for preventative service. Welch Allyn will provide the ac
ecalled defibrillator with a replacement and new five (5) year warranty.
Med intends to replace the affected products with either a new device or a device in which the affected
toring Department at 1-888-744-1414, menu option 1 and then menu option 2.
uation and that the necessary changes in the Operator's Manual concerning the Cleaning, Protein Rem
vised that if they have the GE Solar or the Phillips (HP) models listed in the letter or any monitor not lis
veness checks.
arge when it becomes available. Any questions were directed to the GE Customer Care Center at 800
-689-9101, the enclosed acknowledgment form, indicating the number of affected drivers in their poss
local BrainLAB Customer Support Representative or CAPA Manager Markus Hofman at 49-89-99-15-68
vices at 1-800-843-7867. Baxter sent follow-up Urgent Product Recall letters dated 6/22/07.
permanent correction to the table once it has been validated and approved. Contact Stille Surgical In
battery charger.
failure. Any questions were directed to BrainLAB's customer hotline at 1-800-597-5911.
ion 5 or visit the web site at www.physio-control-notices.com/LP1000.
of the next software revision, service personnel will replace the software at each customer location.
nalyze Setup Option is set to OFF or After First Shock if new software is installed . The default setting f
ite: http://www.gehealthcare.com/usen/security/cis/stupgrades.html, indicating "PFILS ANALYSIS REQU
rge when it becomes available. Any questions were directed to the GE Customer Care Center at 800-4
rkstation software or build number, and fax the completed form to 847-277-5240.
no charge. Any questions were directed to the GE Customer Care Center at 800-437-1171.
nd above, while allowing the use of lower energies using the fixed field electron applicatiors.
are being instructed to avoid the use of the following combination of settings: 1) BIPAP mode; 2) Ramp
k button cover. Customer notification was completed by 9/2/08.

attached Reply Form. Question should be directed to Hospira Customer Service at 1-800-241-4002.
ange service or replacement of the recalled enteral pumps.
f the letter and fax it to 888-569-1585. Direct questions to your local Baxter Representative or to Baxt
T. Once the customer ships the recalled unit to CSZ, the firm will repair the unit(s) using new connecto
on Scientific Corporation CRM Technical Services by calling 1-800-227-3422.
re requested to complete the Mandatory Fax-Back Form acknowledging receipt and understanding of th
HealthCare representative.
ccount customers and install the update. OEM partners will be notified and provided the information a
r Technical Services to upgrade their instruments or have the software sent to them to make the upgra
18-4653. For further information, please contact GE Customer Care Center by telephone at 800-437-1
n, if desired.
543-5047 (press "4" at the prompt).
re upgrade.
m to 847-939-1479.
nter: 1-800-800-4925, which the customer can use to obtain additional information, if desired.
counts were also requested to complete and return the enclosed reply form confirming that the change
oncerning this issue can be obtained by contacting a Philips representative at 1-800-722-9377.
rs. For medical inquiries, the accounts were directed to contact Hospira Medical Communications at 1-
oftware upgrade which corrects the problem.
estions or assistance is needed, customers can contact BD at 1-770-784-6969.
uct with the software upgrade. Records will be maintained accordingly.
will be notified when the software update is ready to be installed on their system.
all_x001D_ letter to consignees which updated and expanded the earlier communication. The FDA clas
e InfusOR and Mini-Infuser System for future refer.
Hospira via fax at 1-888-216-7330.
d to perform a stand-by test to determine if repair and/or servicing are required.
CDI system operatros manual.

CDI system operatros manual.
edtronic
Sales Representative.
ory.Affairs@us.gambro.com.
e enclosed Acknowledgement Form by fax to 215-997-5665 or e-mail: regulatoryaffairs@gendex.com. F
Customer Support District or Regional Manager.
tware implementation the week of March 21, 2011.
of IMPAC software at their organization who are potentially affected by this issue.
customers' local Toshiba Representative at 800-521-1968.
800-421-1968.
ware. The notification also provides the customers with a 1-800 telephone number for STERIS Field Se
ation were directed to Baxter's Medical Information Services at 1-800-422-2751.
should direct their questions to their local Elekta representative.
, or customer support assistance.
anada customers were instructed to contact the Customer Care Solutions Center (1-800-722-9377, opti
or Restart button is selected, the carousel may move to the wrong tube and aspirate sample resulting
ia. The rework will be conducted on-site.
to call their Field Service Representatives or the HMSA Applications Helpline if they have any questions
or if any additional problems are encountered.
owever, if ERI or EOL is triggered, device replacement should be scheduled."*****Recalled units only co
owever, if ERI or EOL is triggered, device replacement should be scheduled."*****Recalled units only co
Baxter Global Technical Services at 1-800-843-7867, prompt 2.
Allyn will provide the accounts with a loaner PIC 50 after receiving the form with instructions to send b
ce in which the affected components have been replaced.
e Cleaning, Protein Removal, and Decontamination programs have been made.
er or any monitor not listed as verified to be compatible with the Vigilance II (Space labs and Nihon Koh
mer Care Center at 800-437-1171.
ted drivers in their possession, and were advised that they would be contacted by a Cardinal Health re
fman at 49-89-99-15-68-44 or 1-800-597-5911 in the U.S.
dated 6/22/07.
Contact Stille Surgical Inc. at 1-800-655-1614 for assistance.
597-5911.
ch customer location.
d . The default setting for the software update is Auto-Analyze ON.
g "PFILS ANALYSIS REQUEST" in the Description of Issue field. Any questions were directed to Technical
er Care Center at 800-437-1171.
00-437-1171.
applicatiors.
1) BIPAP mode; 2) Ramp = highest, and 3) Texp = 0.5 seconds.
e at 1-800-241-4002.
epresentative or to Baxter Global Technical Services by calling 1-800-843-7867, Prompt 2, between 7AM
t(s) using new connectors manufactured, after which time, the repaired unit is returned to distribution
and understanding of the letter.
vided the information and update kits to provide to their customers.
them to make the upgrades, and fax the sheet to 1-847-270-5457. Any questions were directed to Bax
telephone at 800-437-1171.
ation, if desired.
nfirming that the changes have been made.
1-800-722-9377.
al Communications at 1-800-615-0187.
munication. The FDA classified this as a Class I recall.
ryaffairs@gendex.com. For questions regarding this recall call 800-323-8029.
mber for STERIS Field Service Dispatch, to be used if the customers have questions or want to request
er (1-800-722-9377, option 5: Enter Site ID or follow the prompts).
spirate sample resulting in a sample misidentification.
they have any questions about the notice, or if any additional problems are encountered. .
***Recalled units only cover devices implanted prior to July 2005****.

***Recalled units only cover devices implanted prior to July 2005****.
h instructions to send back the PIC 50 in the same shipping box accompanying the loaner unit. Any qu
pace labs and Nihon Kohden models listed above) Edwards recommends verification of MAP accuracy p
by a Cardinal Health representative to arrange for the replacement/service of their drivers. Any ques
ere directed to Technical Support at 800-433-2009.
, Prompt 2, between 7AM and 5 PM Central Standard Time (CST).
returned to distribution for customer use.
ns were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 4, option 1.
ons or want to request additional information. It also provides a local telephone no. 1-440-392-7455, f
countered. .
g the loaner unit. Any questions were directed to Welch Allyn-MRL Technical Support at 1-800-462-0777
cation of MAP accuracy prior to treating based on parameters from a Vigilance II in a "slave" configurat
their drivers. Any questions were directed to Quality Systems-Professional Services at 1-800-292-9332
pt 4, option 1.
ne no. 1-440-392-7455, for obtaining additional information from the firm's Director, Div. of Low Temper
pport at 1-800-462-0777.
II in a "slave" configuration. If there is a difference, they should enter the MAP into the Vigilance II man
vices at 1-800-292-9332 or 1-800-327-7503.
ctor, Div. of Low Temperature Sterilization at: 1-440-392-7455.
nto the Vigilance II manually for a static calculation of SVR. Edwards will be supplying a software upda
pplying a software update to correct this problem.

Automotive recall numbers from 2006-2008

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Automotive recall numbers from 2006-2008

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Recall_Number

an in vitro diagnostic kit consisting of microparticles; conjugate; assay

LIFEPAK 20 - LIFEPAK 20 automatic external defibrillator

Epic - Stryker Epic Critical Care Bed; Model 2030.

2+ Defibrillator Automated External Defibrillator (AED)Catalog Numbers:

Stimulation System - The Precision Implantable Pulse Generator; Model

nd Computed Tomography) System with a Pinhole Collimator; Siemens

services. The EasyVision RAD provides the following features: receives

ealthcare Innova 3100 Digital Fluoroscopic Imaging (Cardiovascular

le Preparation - Vidiera NsP Nucleic Sample Preparation; Part Number:

-2061.Indications for use: SPECT + CT: Perform scans and nuclear 2

rt G3 - Cardiac Science Powerheart Automated External Defibrillator

g number 04862392001; catalog number 05093236001; and catalog

Heartstart (HS1) Onsite Automated External Defibrillator (AED) Catalog

stems are indicated for use in generating fluoroscopic images of human

; for use with radiotherapy treatment machines; Class IIb; manufactured

on 4.0.4.7 Manufactured 02/03/2010. Version 4.5.1.3 Manufactured

rlando; FL 32826 Made in U.S.A.***REF 3160DCU***SN***CAUTION:

soft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED

tional images of the body by computer reconstruction of x-ray transmission

ng clinical chemistry; specific protein and electrolyte tests. Analytes

ONE - Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) - Whole Body

#K033326; Model Number: 728231; Serial Numbers: 9745; 90169;

oes not contain

ailure inside the GE equipment

Surgery, Anesthesia, ICU, Nursing, Risk Management and Biomedical Engineering.

ated the letter for their customers.

of installation at all accounts by 3/31/06.

nd future upgrade by wireless RF telemetry. .

enter at 800-722-9377, #5, #2.

Care Center at 1-800-437-1171.

unanticipated disruption in their use of their product;

al customers) to request the replacement kits you will need; and

certified mail (domestic) and FedEx (international).

ns should be directed to Abbott Point of Care Technical Support at 1-800-366-8010, Option 1.

ence "FC0 70600030" with any communication.

erence FCO 83000129 for any questions.

be scheduled as we receive your business reply form.

ed to you at the time of the update.

port for any question about this recall.

East Asia: seasia.apps.helpdesk@varian.com; China/Asia: china.apps.helpdesk@varian.com; Japan: Jap

your local Philips representative.

tify them of the need to install the corrected LPI Software.

) or +1-408-716-4700 (non USA) or by email: customersupport@accuray.com.

ware update beginning November 2009.

ntains a return reply form that is to be faxed to TAMS as proof of notification.

Engineer. For further questions please call (440) 483-7000.

866-777-0202 and speak to their Support Manager.

Help desk at 888-778-3375.

d in device labeling. For implanted devices, continue normal follow-up.

lso be recorded on the log.

as not yet received confirmation that this was completed.

re version is scheduled to be released to correct the error.

ack to St. Jude Medical CRMD in Sylmar.

e Correction Notice a procedure to mitigate risk until the upgrade is installed.

long term solution of updating the software.

n 2.5 mbar is used .

nclosed response form. The Letter was sent by US Mail.

asked to be returned to initiate the upgrade process.

oftware to their system was mandatory. .

the correct software.

d as replacement components become available.

and assembly of cosmetic brake or apply caution labels.

rlando; FL 32826 Made in U.S.A.REF 3160DCUSN***CAUTION:

softNeuViz16 MULTI-SLICE CT SCANNER SYSTEMMANUFACTURED