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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare/Ohmeda Medical Giraffe OmniBed.

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 Class 2 Recall
GE Healthcare/Ohmeda Medical Giraffe OmniBed.
see related information
Date Posted November 21, 2008
Recall Status1 Terminated on March 24, 2010
Recall Number Z-0305-2009
Recall Event ID 49097
Product Classification Incubator, Neonatal - Product Code FMZ
Product 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.
Code Information All lots.
Recalling Firm/
Manufacturer
Datex Ohmeda, Inc. dba GE Healthcare
8880 Gorman Rd
Laurel, Maryland 20723-5800
For Additional Information Contact Ann M. Lebar
410-888-5200
Manufacturer Reason
for Recall
Manufacturer of neonatal incubators changed the device labeling to account for new use and care instructions.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 additional information. If outside of the USA, please contact your local GE Healthcare Service Representative.
Quantity in Commerce 7,878 beds
Distribution Worldwide Distribution: The devices were widely distributed to national and international medical facilities.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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