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