The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1070-2014·Announced 2014-03-05

GE Healthcare Recalls Infant Resuscitation Systems Due to Reversed Fittings

GE Healthcare is recalling Giraffe and Panda infant resuscitation systems because oxygen and air inlet fittings were reversed during assembly.

The agency’s classification

FDA (Devices): Class I

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly."

Plain-English summary

GE Healthcare, LLC is recalling specific units of the Giraffe Warmer, Panda Warmer, Panda iRes Warmer, and Giraffe Stand-alone Infant Resuscitation System. These devices are used to provide basic equipment for pulmonary resuscitation of infants, including establishing a clear airway and providing oxygen or air mixtures.

The recall was initiated because the oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. This manufacturing error could affect the proper delivery of gases to the infant during resuscitation procedures.

The recall involves 12,373 units distributed worldwide, including 8,807 units in the United States. Affected units are identified by specific lot codes listed in the official recall notice. Healthcare facilities and consumers should check their inventory against the provided lot codes and contact GE Healthcare for instructions on how to proceed.

The recalled product

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…
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Infant Resuscitation Equipment
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • QABR50042
  • QABR50036
  • QABR50082
  • QABR50110
  • QABR50111
  • QABR50031
  • QABR50008
  • QABS50107
  • QABS50108
  • QABS50139
  • QABR50009
  • QABR50043
  • QABS50017
  • QABS50072
  • QABS50129
  • QABS50076
  • QABR50005
  • QABR50060
  • QABR50035
  • QABS50084

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 3 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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