Reported Jul 17, 2019 · Terminated
Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are…
GE Healthcare, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.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?
- Giraffe 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 or to provide a controlled open environment.
- Lot codes and dates
631 of 631 products
Products covered by this recall # Product as published 1 Model Number, (Serial Number, UDI Number): M1118179-529707 (GBWW60444, 010084068210392321GBWW6044411170620) 2 M1118179-529707 (GBWW60446, 010084068210392321GBWW6044611170620) 3 M1118179-024201 (HDJM50619, Not Applicable) 4 M1118179-024201 (HDJM50620, Not Applicable) 5 M1118179-025977 (HDJN50298, Not Applicable) 6 M1118179-025977 (HDJN50299, Not Applicable) 7 M1118179-029089 (HDJP50554, Not Applicable) 8 M1118179-029089 (HDJP50555, Not Applicable) 9 M1118179-038813 (HDJR54214, Not Applicable) 10 M1118179-038813 (HDJR54215, Not Applicable) 11 M1118179-038813 (HDJR54216, Not Applicable) 12 M1118179-024011 (HDJS50551, Not Applicable) 13 M1118179-024011 (HDJS50552, Not Applicable) 14 M1118179-024011 (HDJS50553, Not Applicable) 15 M1118179-024011 (HDJS50554, Not Applicable) 16 M1118179-024011 (HDJS50555, Not Applicable) 17 M1118179-150421 (HDJU61285, Not Applicable) 18 M1118179-150421 (HDJU61286, Not Applicable) 19 M1118179-150421 (HDJU61287, Not Applicable) 20 M1118179-150421 (HDJS52930, Not Applicable) - Amount recalled
- 9,094 devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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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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