The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1847-2019·Announced 2019-07-17

GE Healthcare Recalls Panda Infant Radiant Warmers Due to Bedside Panel Cracking

GE Healthcare is recalling 28,094 Panda Infant Radiant Warmers because the bedside panels and latch areas can crack or break if the unit is moved using them 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 28,094 units of the Panda 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.

The affected devices are distributed worldwide, including across all 50 US states, DC, Guam, and the Northern Mariana Islands, as well as numerous international countries. The source text notes that the defect also affects the Giraffe Bedded Warmer and Panda iRes Warmer, though the specific recall quantity and distribution details provided in the structured data pertain to the Panda Infant Radiant Warmer.

No injuries or illnesses have been reported in the source text. Consumers and healthcare facilities should check their device serial numbers against the list provided by the manufacturer and contact GE Healthcare for instructions on how to proceed with the recall.

The recalled product

Product
Panda 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 — Infant Radiant Warmer
Hazard
Affected units
28,094

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): M1112198-526438 (PBWX70184
  • 010084068210392321GBWX7012911180423)
  • M1112198-526773 (PBWX71881
  • Not Applicable)
  • M1112198-023402 (HDJQ51784
  • M1112198-023402 (HDJQ51785
  • M1112198-023402 (HDJQ51786
  • M1112198-023402 (HDJQ51787
  • M1112198-025399 (HDJR56841
  • M1112198-025399 (HDJR56842
  • M1112198-025399 (HDJR56843
  • M1112198-025399 (HDJR56844
  • M1112198-025399 (HDJR56845
  • M1112198-025399 (HDJR56846
  • M1112198-025399 (HDJR56847
  • M1112198-025399 (HDJR56848
  • M1112198-025399 (HDJR56849
  • M1112198-025399 (HDJR56850

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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