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.
Recall
- Recall Number
- Z-0305-2009
- Event Number
- 49097
- Firm
- Datex Ohmeda, Inc. dba GE Healthcare
- FEI Number
- 1121732
- Product Code
- FMZ
- Status
- Terminated
- Root Cause
- Equipment maintenance
- Initiated
- June 20, 2008
- Posted
- November 21, 2008
- Terminated
- March 24, 2010
- Address
- 8880 Gorman Rd, Laurel, MD, 20723-5800
Description
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.
Manufacturer of neonatal incubators changed the device labeling to account for new use and care instructions.
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.
Worldwide Distribution: The devices were widely distributed to national and international medical facilities.
7,878 beds