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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 Device Recall Panda iRes and Giraffe Infant Warmers see related information
Date Initiated by Firm May 20, 2008
Date Posted September 11, 2008
Recall Status1 Terminated 3 on May 11, 2012
Recall Number Z-2227-2008
Recall Event ID 48603
510(K)Number k070377  
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.
Code Information 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and HDJL50061 
Recalling Firm/
Manufacturer		 Datex Ohmeda, Inc. dba GE Healthcare
8880 Gorman Rd
Laurel MD 20723-5800
For Additional Information Contact Ann Lebar
414-721-3257
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FMT and Original Applicant = OHMEDA MEDICAL
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