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.
FDA Recall Z-0305-2009 · Posted 2008-11-21
Recalling FirmDatex Ohmeda, Inc. dba GE Healthcare
Recall StatusTerminated
Product CodeFMZ
Date Initiated2008-06-20
Date Terminated2010-03-24
Product Quantity7,878 beds
Reason for Recall
Manufacturer of neonatal incubators changed the device labeling to account for new use and care instructions.
Firm 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 additional information. If outside of the USA, please contact your local GE Healthcare Service Representative.
Root Cause
Equipment maintenance
Distribution Pattern
Worldwide Distribution: The devices were widely distributed to national and international medical facilities.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.