Food, drugs, devices › GE Healthcare, LLC
Device recall: GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product
GE Healthcare, LLC (Waukesha, WI) initiated this device recall on 1 Oct 2013; FDA lists 3 product records under event 67004, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 6% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 22 Jul 2016. Initiation: voluntary: firm initiated. GE Healthcare, LLC has 225 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
GE Healthcare, LLC, Waukesha, WI.
Reason for recall
"Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly."
Distribution
"Worldwide Distribution - USA Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL,GA. HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1070-2014 | 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… | 12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown | Class I | Terminated | 5 Mar 2014 |
| Z-1071-2014 | GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage: The Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a… | 12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown | Class I | Terminated | 5 Mar 2014 |
| Z-1072-2014 | 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… | 12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown | Class I | Terminated | 5 Mar 2014 |
Context
Other enforcement events for GE Healthcare, LLC
All 225 events for GE Healthcare, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - USA Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL,GA. HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 22 Jul 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.