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.
Recall
- Recall Number
- Z-2227-2008
- Event Number
- 48603
- Firm
- Datex Ohmeda, Inc. dba GE Healthcare
- FEI Number
- 1121732
- Product Code
- FMT
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- May 20, 2008
- Posted
- September 11, 2008
- Terminated
- May 11, 2012
- Address
- 8880 Gorman Rd, Laurel, MD, 20723-5800
Description
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.
Medical device software may be subject to signal interference of the Hands Free Alarm Silence feature that could impact patient safety.
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.
The medical devices were distributed to hospitals nationwide.
639 devices