Reported Feb 12, 2014 · Terminated
Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part…
GE Healthcare
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 · 8880 Gorman Rd · Laurel, MD · 20723-5800
Is this the product you have?
- Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com** Panda Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.
- Lot codes and dates
- Serial NumbersHD
2,962 of 2,962 codes
HDJQ52826HDJR50704HDJR54140HDJR54141HDJR54142HDJR54143HDJS50670HDJS50671HDJS50672HDJS50678HDJS50679HDJS50681HDJS50682HDJS50684HDJS50686HDJR56405HDJS52316HDJP51364HDJP51369HDJP51376HDJP51379HDJP51380HDJP51381HDJR56387HDJR56388HDJR56389HDJR56390HDJR56391HDJR56666HDJN50977HDJN50978HDJQ53071HDJM51282HDJM51283HDJM51284HDJM51285HDJM51286HDJM51287HDJM51288HDJM51289HDJM51290HDJM51291HDJM51292HDJM51293HDJM51294HDJM51295HDJQ50845HDJQ50846HDJQ50361HDJQ50362HDJQ50363HDJQ50364HDJQ50365HDJQ52097HDJM51403HDJM51871HDJP52195HDJP52198HDJP52199HDJP52200
- Serial Numbers
- Amount recalled
- 9232 units
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
- PR
Why it was recalled
Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
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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