The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1072-2014·Announced 2014-03-05

GE Healthcare Recalls Giraffe and Panda Infant Warmers Due to Reversed Fittings

GE Healthcare is recalling Giraffe and Panda iRes Infant Warmers because oxygen and air wall 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 the Giraffe and Panda iRes Infant Warmers. These infant radiant warmers provide infrared heat to neonates who are unable to thermo-regulate based on their own physiology. The devices may also be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment, with an optional integrated SpO2 monitoring feature.

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 affects the proper function of the resuscitation system components.

A total of 12,373 units are affected, with 8,807 units distributed in the United States, 3,394 units outside the US, and 172 units of unknown distribution. The devices were distributed nationwide in the US and to numerous countries worldwide. Healthcare facilities should contact GE Healthcare for instructions on how to address the reversed fittings.

The recalled product

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…
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Infant Warmer
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)

  • HDJQ52826
  • HDJR52093
  • HDJR50704
  • HDJR54140
  • HDJR54141
  • HDJR54142
  • HDJR54143
  • HDJQ52878
  • HDJS50670
  • HDJS50671
  • HDJS50672
  • HDJS50678
  • HDJS50679
  • HDJS50681
  • HDJS50682
  • HDJS50684
  • HDJS50686
  • 208600
  • 208601
  • 208610

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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