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Electronic Signature Information

Name DOC2319939

Revision 2

Type Controlled Document

Title FMI 32070 MIC English Master UMDC Customer Letter

Reason For Change issue with arrows moving updated arrows as a picture

Originator 212050077_beth_m_schiro

Release Date 10/15/2019 11:46:30 AM

Obsolete Date

File Name File Description File Size (Bytes)

FMI32070 UMDC Letter FMI 32070 MIC English Master
542237
IncubatorOmnibedPanelPSRB10OCT2019.docx UMDC Customer Letter
ElectronicSignatureInfo_Released.html Electronic Signature HTML file 3362

Route Signer Function Status Comments Completion Date

Approved Without 15 Oct 2019 11:46:29
R-9554115 403012375_laila__gurney Approve
Comments GMT
Approved without 11 Oct 2019 16:11:42
R-9554115 212066281_jeffrey__hersh Approve
Comments GMT

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GE Healthcare
URGENT MEDICAL DEVICE RECALL 3000 N. Grandview Blvd. - W440
Waukesha, WI 53188, USA

<Date of Letter Deployment> GEHC Ref# 32070

To: Director of Biomedical Engineering

Director of Neonatology/ L and D/ Nurse Manager
Risk Manager/Hospital Administrator

RE: Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation – Bedside
panels and portholes can appear closed without being latched - Potential patient fall

This document contains important information for your product. Please ensure that all potential
users in your facility are made aware of this safety notification and the recommended actions.
Please retain this document for your records.

Safety  The bedside panels of Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation,
Issue and Giraffe OmniBed Carestation can be upright and look closed but not be latched.
 The portholes also can look closed when not latched.
 If a canopy cover is used, it can hold the bedside panel or porthole door closed without
being latched.
If a bedside panel or porthole that is not latched falls open, it will no longer protect the patient
from falling.

Safety You can continue to use your Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator
Instructions Carestation and Giraffe OmniBed Carestation by following the four instructions below:

• Each time the bedside panel is closed, make sure the red tab is no longer visible (see
Figures 1 and 2).

Figure 1. Figure 2.
UNLATCHED LATCHED
bedside panel bedside panel
The red tab The red tab no
shows the longer visible
latch is not shows the
engaged. bedside panel
is latched

• Each time the porthole doors are closed, manually check the porthole latches to make
sure the porthole door latches are secure (see Figure 3).
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Figure 3. LATCHED (left) and UNLATCHED (right) portholes

• You must pull on the porthole door every time the bedside panel or porthole is closed to
make sure the porthole door is latched.

• The device is intended to be used by healthcare professionals. If a non-healthcare

professional comes into contact with the device, you must check the latches every time to
ensure that panels and portholes are closed.

Affected All Giraffe Incubators and Giraffe OmniBeds*

Product
Giraffe Incubator Carestation (2082844-002-XXX) [GTIN – 010084068211685521]
Details
Giraffe OmniBed Carestation (2082844-001-XXX) [GTIN – 010084068211686221]

*NOTE: Some products were shipped prior to implementation of UDI and may not contain a
Global Trade Item Number (GTIN).

Product GE Healthcare will provide a user manual addendum, labels for the device, and instructional
Correction posters materials in a future mailing at no cost to you.

Contact If you have any questions or concerns regarding this notification, please contact GE
Information Healthcare Service at 1-800-437-1171 or your local Service Representative.

Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any
questions, please contact us immediately per the contact information above.

Sincerely,

Laila Gurney Jeff Hersh, PhD MD

Senior Executive, Quality & Regulatory Chief Medical Officer
GE Healthcare GE Healthcare
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GE Healthcare
GEHC Ref# 32070
MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT
RESPONSE REQUIRED

Please complete this form and return it to GE Healthcare promptly upon receipt and no later than 30 days
from receipt. This will confirm receipt and understanding of the Medical Device Correction Notice and required
actions to be taken Ref# 32070.

Customer/Consignee Name:

Street Address:

City/State/ZIP/Country:

Email Address:

Phone Number:

We acknowledge receipt and understanding of the accompanying Medical Device Notification, and that we have
taken and will take appropriate actions in accordance with that Notification.

Please provide the name of the individual with responsibility who has completed this form.

Signature:

Printed Name:

Title:

Date (DD/MM/YYYY):

Please return completed form to FAX NUMBER: +1-410-630-5579, or scanning or taking a

photo of the completed form e-mailing to: MIC.Recall32070@ge.com
You may obtain this e-mail address through the QR code below:
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