Reported Nov 28, 2018 · Terminated

Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes…

GE Healthcare, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615

Is this the product you have?

  • Panda iRes Infant Radiant Warmer. Device
  • sold under the following product namesPanda iRes Warmer and Panda iRes Bedded Warmer
Lot codes and dates

654 of 654 products

Products covered by this recall
#Product as published
1Model Number, UDI (Serial Number): M1112198-526395, 010084068210389321PBWX7040911180413 (PBWX70409)
2M1112198-164657, Not Applicable (HDJT50683)
3M1112198-018125, Not Applicable (HDJM50048)
4M1112198-023789, Not Applicable (HDJM50529)
5M1112198-023787, Not Applicable (HDJM50528)
6M1112198-027124, Not Applicable (HDJP50065)
7M1112198-018125, Not Applicable (HDJM50047)
8M1112198-022592, Not Applicable (HDJM50596)
9M1112198-023488, Not Applicable (HDJQ50744)
10M1112198-024139, Not Applicable (HDJQ50819)
11M1112198-023359, Not Applicable (HDJR50385)
12M1112198-023359, Not Applicable (HDJR50389)
13M1112198-023359, Not Applicable (HDJR50382)
14M1112198-171607, Not Applicable (HDJS50605)
15M1112198-023391, Not Applicable (HDJM50439)
16M1112198-052019, Not Applicable (HDJR50487)
17M1112198-018105, Not Applicable (HDJM50140)
18M1112198-018105, Not Applicable (HDJM50139)
19M1112198-019900, Not Applicable (HDJM50471)
20M1112198-018105, Not Applicable (HDJM50138)
Amount recalled
1,724 devices total

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

  • Nationwide

Why it was recalled

Potential electric leakage affecting the user.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 13, 2020 · Data as of Sep 19, 6:14 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.