Recall Z-1072-2014— GE Healthcare, LLC

Name: FDA recall Z-1072-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-01

Class I · Terminated

Class I FDA medical device recall by GE Healthcare, LLC, initiated 2013-10-01, terminated 2016-07-22. It names 4 FDA 510(k) clearances: K122267, K101804, K090697 and 1 more. Product: GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonates transition to the external environment or to provide a controlled open environment. An optional integrated Sp02 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate.. Reason: Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly..

Recalling firm: GE Healthcare, LLC
Classification: Class I
Status: Terminated
Initiated: 2013-10-01
Terminated: 2016-07-22
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

4 on FDA's record

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

GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonates transition to the external environment or to provide a controlled open environment. An optional integrated Sp02 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate.

Reason for recall

Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.

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