The Recall Desk
HighFDA (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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a critical medical device used for infant resuscitation where a defect (reversed fittings) poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

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 r
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 →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · defective assembly

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