Recall Z-0481-2019— GE Healthcare, LLC

Name: FDA recall Z-0481-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-25

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2018-09-25, terminated 2020-07-13. It names 5 FDA 510(k) clearances: K123309, K122267, K101804 and 2 more. Product: Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.. Reason: Potential electric leakage affecting the user..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-09-25
Terminated: 2020-07-13
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

5 on FDA's record

K123309 — GIRAFFE AND PANDA WARMERSOhmeda Medical·cleared 2013-02-05
K122267 — GIRAFFE AND PANDA WARMERSOhmeda Medical, A Division of Datex-Ohmeda, Inc.·cleared 2012-10-02
K101804 — GIRAFFE AND PANDA WARMERSOhmeda Medical, A Division of Datex-Ohmeda, Inc.·cleared 2010-07-21
K090697 — MODIFICATION TO: GIRAFFE AND PANDA WARMEROhmeda Medical·cleared 2009-04-16
K070377 — GIRAFFE AND PANDA WARMEROhmeda Medical·cleared 2007-07-11

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 Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.

Reason for recall

Potential electric leakage affecting the user.

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