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U.S. Department of Health and Human Services

Class 2 Device Recall Panda iRes and Giraffe Infant Warmers

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 Class 2 Recall
Panda iRes and Giraffe Infant Warmers
see related information
Date Posted September 11, 2008
Recall Status1 Open
Recall Number Z-2227-2008
Recall Event ID 48603
Premarket Notification
510(K) Number
Product Classification Warmer, Infant Radiant - Product Code FMT
Product Panda® iRes and Giraffe® Infant Warmers, labeled in part*** GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com*** Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.
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Recalling Firm/
Datex Ohmeda, Inc. dba GE Healthcare
8880 Gorman Rd
Laurel, Maryland 20723-5800
For Additional Information Contact Ann Lebar
Manufacturer Reason
for Recall
Medical device software may be subject to signal interference of the Hands Free Alarm Silence feature that could impact patient safety.
FDA Determined
Cause 2
DESIGN: Software Design
Action The recalling firm notified Hospital Administrators, NICU Nursing Manager/Labor & Delivery Nursing Managers and Heads of Biomedical Engineering departments at consignee locations by certified letter on 05/20/08. The notification was flagged as "Urgent Medical Device Correction" and advised consignees of safety issues and recommended actions when using the device. The notification advised that the safest way to mitigate the potential interference issue is to disable the Hands Free Alarm Silence. Users were informed that once a permanent correction action is identified, service representatives will implement the correction. For assistance, contact GE Healthcare at 1-800-345-2700.
Quantity in Commerce 639 devices
Distribution The medical devices were distributed to hospitals nationwide.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMT and Original Applicant = OHMEDA MEDICAL