Agency classClass IIOur severity:High FDA (Devices)·Z-0482-2019·Announced 2018-11-28

GE Healthcare Recalls Panda iRes Infant Radiant Warmers Due to Electric Leakage

GE Healthcare is recalling 1,724 Panda iRes Infant Radiant Warmers worldwide due to a potential electric leakage hazard that could affect users.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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 is classified as FDA Class II, and the hazard involves potential electric leakage (electrical shock) without reported injuries or deaths, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling 1,724 units of the Panda iRes Infant Radiant Warmer, also sold as the Panda iRes Warmer and Panda iRes Bedded Warmer. The recall is due to a potential electric leakage that could affect the user.

The affected devices were distributed worldwide, including in the United States and numerous international markets. The source text does not specify the exact dates of distribution or the specific model numbers affected beyond the general product identification.

Consumers and healthcare facilities should stop using the affected devices and contact GE Healthcare for further instructions on repair, replacement, or refund. The recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product: Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Infant Care
Hazard: electric-shock
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): M1112198-526395
010084068210389321PBWX7040911180413 (PBWX70409)
M1112198-164657
Not Applicable (HDJT50683)
M1112198-018125
Not Applicable (HDJM50048)
M1112198-023789
Not Applicable (HDJM50529)
M1112198-023787
Not Applicable (HDJM50528)
M1112198-027124
Not Applicable (HDJP50065)
Not Applicable (HDJM50047)
M1112198-022592
Not Applicable (HDJM50596)
M1112198-023488
Not Applicable (HDJQ50744)
M1112198-024139
Not Applicable (HDJQ50819)

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 →

Same manufacturer · GE Healthcare, LLC

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Same hazard · electric shock