The Recall Desk
HighFDA (Devices)·Z-0481-2019·Announced 2018-11-28

GE Healthcare Recalls Giraffe Infant Warmers Due to Electric Leakage Risk

GE Healthcare is recalling 1,724 Giraffe infant radiant warmers worldwide due to a potential electric leakage hazard that could affect users.

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 medical device with a potential electric leakage hazard. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and it is not classified as FDA Class I.

Plain-English summary

GE Healthcare, LLC is recalling 1,724 Giraffe infant radiant warmers, sold under the product names Giraffe Warmer and Giraffe Bedded Warmer. The recall is due to a potential electric leakage issue that could affect the user. The devices were distributed worldwide, including in the United States and numerous international markets.

The source text does not specify the exact nature of the electric leakage or report any specific injuries or illnesses associated with the defect. Affected devices are identified by specific model numbers and serial numbers listed in the official recall documentation.

Healthcare facilities and users should check their device serial numbers against the recall list. If a device is affected, it should be removed from service and returned to GE Healthcare for repair or replacement according to the manufacturer's instructions.

The recalled product

Product
Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Infant Radiant Warmer
Hazard
Affected units
1,724

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
  • UDI (Serial Number): M1118179-018104
  • Not Applicable (HDJM50056)
  • M1118179-018118
  • Not Applicable (HDJM50178)
  • M1118179-024117
  • Not Applicable (HDJM50583)
  • Not Applicable (HDJM50094)
  • M1118179-022861
  • Not Applicable (HDJR54165)
  • M1118179-020841
  • Not Applicable (HDJM50142)
  • Not Applicable (HDJQ50967)
  • Not Applicable (HDJQ50971)
  • Not Applicable (HDJQ50973)
  • Not Applicable (HDJQ50972)
  • Not Applicable (HDJQ50974)
  • M1118179-022643
  • Not Applicable (HDJM52091)
  • M1118179-018104

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · electric leakage

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