Z-0305-2009

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

Name: Z-0305-2009 Giraffe OmniBed, labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A...
Creator: Datex Ohmeda, Inc. dba GE Healthcare
Published: 2008-06-20
License: https://open.fda.gov/license/

GE Healthcare / initiated 2008-06-20 / Terminated / root cause: manufacturing process

FDA source

Datex Ohmeda, Inc. dba GE Healthcare began a recall of 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... on 2008-06-20. The reason FDA records is "Manufacturer of neonatal incubators changed the device labeling to account for new use and care instructions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0305-2009
Status: Terminated
Initiated: 2008-06-20
Posted: 2008-11-21
Terminated: 2010-03-24
Recalling firm: GE Healthcare
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.
Product code: FMZ Incubator, Neonatal
Reason for recall: Manufacturer of neonatal incubators changed the device labeling to account for new use and care instructions.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: All lots.

Product code FMZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)