Recall Z-1051-2013— GE Healthcare, LLC

Name: FDA recall Z-1051-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-08

Class I · Terminated

Class I FDA medical device recall by GE Healthcare, LLC, initiated 2013-01-08, terminated 2013-07-10. It names 2 FDA 510(k) clearances: K101778, K101788. Product: Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer.. Reason: Neonatal beds and incubator display boards may randomly overwrite stored information and radiant heater and oxygen set points upon power up or recovery from a power failure..

Recalling firm: GE Healthcare, LLC
Classification: Class I
Status: Terminated
Initiated: 2013-01-08
Terminated: 2013-07-10
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

2 on FDA's record

K101778 — GIRAFFE INCUBATOROhmeda Medical·cleared 2010-07-21
K101788 — GIRAFFE OMNIBEDOhmeda Medical·cleared 2010-07-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer.

Reason for recall

Neonatal beds and incubator display boards may randomly overwrite stored information and radiant heater and oxygen set points upon power up or recovery from a power failure.

Data sourced from openFDA. This site is unofficial and independent of the FDA.