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.
FDA Recall Z-2227-2008 · Posted 2008-09-11
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Recalling FirmDatex Ohmeda, Inc. dba GE Healthcare
Recall StatusTerminated
Product CodeFMT
Date Initiated2008-05-20
Date Terminated2012-05-11
Product Quantity639 devices
Reason for Recall
Medical device software may be subject to signal interference of the Hands Free Alarm Silence feature that could impact patient safety.
Firm 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.
Root Cause
Software design
Distribution Pattern
The medical devices were distributed to hospitals nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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