Giraffe OmniBed…

Date posted by the FDA

Nov. 21, 2008

Status

Terminated

Filed by

Datex Ohmeda, Inc. dba 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.

Reason

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

Distribution pattern

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

Quantity

7,878 beds

Codes and lots

All lots.

Recall started

June 20, 2008

Device type

Incubator, Neonatal

Root cause (FDA)

Equipment maintenance

What the company told customers

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.

Recall number

Z-0305-2009

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0305-2009. The agency record governs; check it and the company before acting.