Giraffe OmniBed, labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. The

FDA device recall Z-0305-2009 · posted 2008-11-21 · Terminated

Recall details

Recalling firm

Datex Ohmeda, Inc. dba GE Healthcare

Reason for recall

Manufacturer of neonatal incubators changed the device labeling to account for new use and care instructions.

Action taken

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

Status

Terminated

Product code

FMZ

Quantity affected

7,878 beds

Distribution

Worldwide Distribution: The devices were widely distributed to national and international medical facilities.

Date initiated

2008-06-20

Date posted

2008-11-21

Date terminated

2010-03-24

Location

Laurel, MD