The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1846-2019·Announced 2019-07-17

GE Healthcare Recalls Giraffe Infant Radiant Warmers Due to Panel Cracking

GE Healthcare is recalling 9,094 Giraffe Infant Radiant Warmers because bedside panels and latch areas can crack or break if the unit is moved using the panels instead of the designated handles.

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: "The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the maneuvering handle."

Plain-English summary

GE Healthcare, LLC is recalling 9,094 units of the Giraffe Infant Radiant Warmer. The recall was initiated because the bedside panels and latch areas on the device can crack or break if the unit is moved using the bedside panels instead of the front handle or the maneuvering handle.

Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. These devices may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.

The affected devices were distributed nationwide in the United States and to numerous countries worldwide. The source text does not specify specific actions for consumers or healthcare providers beyond the description of the defect.

The recalled product

Product
Giraffe Infant Radiant Warmer 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 neonate's transition to the external environment…
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Neonatal Care Equipment
Hazard
Affected units
9,094

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)

  • Model Number
  • (Serial Number
  • UDI Number): M1118179-529707 (GBWW60444
  • 010084068210392321GBWW6044411170620)
  • M1118179-529707 (GBWW60446
  • 010084068210392321GBWW6044611170620)
  • M1118179-024201 (HDJM50619
  • Not Applicable)
  • M1118179-024201 (HDJM50620
  • M1118179-025977 (HDJN50298
  • M1118179-025977 (HDJN50299
  • M1118179-029089 (HDJP50554
  • M1118179-029089 (HDJP50555
  • M1118179-038813 (HDJR54214
  • M1118179-038813 (HDJR54215
  • M1118179-038813 (HDJR54216
  • M1118179-024011 (HDJS50551
  • M1118179-024011 (HDJS50552
  • M1118179-024011 (HDJS50553
  • M1118179-024011 (HDJS50554

Distribution

Distributed nationwide across the United States.

The notice also names 53 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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