Recall Z-0482-2019— GE Healthcare, LLC

Name: FDA recall Z-0482-2019
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: Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded 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

Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.

Reason for recall

Potential electric leakage affecting the user.

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