Recall Z-2235-2020— GE Healthcare, LLC

Name: FDA recall Z-2235-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-28

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2020-04-28, terminated 2024-09-23. It names 2 FDA 510(k) clearances: K101788, K020543. Product: Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.. Reason: Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-04-28
Terminated: 2024-09-23
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 with installed Servo Oxygen module. Infant incubator and warmer.

Reason for recall

Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed.

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