Recall Z-0538-2020— GE Healthcare, LLC

Name: FDA recall Z-0538-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-11

Class I · Terminated

Class I FDA medical device recall by GE Healthcare, LLC, initiated 2019-10-11, terminated 2024-08-15. It names 2 FDA 510(k) clearances: K101788, K020543. Product: Giraffe OmniBed infant warmer. Reason: Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall..

Recalling firm: GE Healthcare, LLC
Classification: Class I
Status: Terminated
Initiated: 2019-10-11
Terminated: 2024-08-15
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

2 on FDA's record

K101788 — GIRAFFE OMNIBEDOhmeda Medical·cleared 2010-07-21
K020543 — OHMEDA MEDICAL GIRAFFE OMNIBEDOhmeda Medical·cleared 2002-05-09

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 infant warmer

Reason for recall

Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.

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