Panda iRes and Giraffe Infant Warmers, labeled in part*** GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.geh
FDA device recall Z-2227-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- Datex Ohmeda, Inc. dba GE Healthcare
- Reason for recall
- Medical device software may be subject to signal interference of the Hands Free Alarm Silence feature that could impact patient safety.
- Action taken
- 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
- Status
- Terminated
- Product code
- FMT
- Quantity affected
- 639 devices
- Distribution
- The medical devices were distributed to hospitals nationwide.
- Date initiated
- 2008-05-20
- Date posted
- 2008-09-11
- Date terminated
- 2012-05-11
- Location
- Laurel, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GIRAFFE AND PANDA WARMER (K070377) | Ohmeda Medical | 2007-07-11 |