Recall Z-2227-2008 ยท FMT Warmer, Infant Radiant
Datex Ohmeda, Inc. dba GE Healthcare
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.
| Date | Sep 11, 2008 (initiated May 20, 2008) |
| Status | Terminated |
| Reason | Medical device software may be subject to signal interference of the Hands Free Alarm Silence feature that could impact patient safety. |
| Root cause | 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 |
| Quantity | 639 devices |
| Distribution | The medical devices were distributed to hospitals nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070377 | GIRAFFE AND PANDA WARMER Ohmeda Medical, Jul 11, 2007 |