Recall Z-1070-2014— GE Healthcare, LLC

Name: FDA recall Z-1070-2014
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 one FDA 510(k) clearance: K070210. Product: GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: The T-Piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care.. 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

1 on FDA's record

K070210 — GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEMOhmeda Medical·cleared 2007-04-20

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 Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: The T-Piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care.

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.