Recall Z-0305-2009 ยท FMZ Incubator, Neonatal
Datex Ohmeda, Inc. dba GE Healthcare
Giraffe OmniBed, labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand.
| Date | Nov 21, 2008 (initiated Jun 20, 2008) |
| Status | Terminated |
| Reason | Manufacturer of neonatal incubators changed the device labeling to account for new use and care instructions. |
| Root cause | Equipment maintenance |
| Action | A notification letter (Urgent Medical Device Correction) was sent to consignees on 06/20/08. The notification letter addressed healthcare professionals, including neonatal, infection control and nursing departments at medical facilities. In add tion, the letter advised of revisions to the current Giraffe OmniBed cleaning instructions contained in the product Operators Manual. Instructions were enclosed with the notification letter and are intended to supplement those already present in the manual. Contact the GE Healthcare Technical Support center at 1-800-558-7044 for questions or additiona |
| Quantity | 7,878 beds |
| Distribution | Worldwide Distribution: The devices were widely distributed to national and international medical facilities. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.