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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 12 Results
510(K) Number: K123309
 
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Product Description
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FDA Recall
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Giraffe® Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road La... 2 02/03/2014 GE Healthcare
Panda iRes® Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568... 2 02/03/2014 GE Healthcare
Panda® Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neo... 2 05/06/2014 GE Healthcare
Panda® iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who... 2 05/06/2014 GE Healthcare
Giraffe® Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who ar... 2 05/06/2014 GE Healthcare
Panda® Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neona... 2 05/06/2014 GE Healthcare
Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded War... 2 11/19/2018 GE Healthcare, LLC
Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer a... 2 11/19/2018 GE Healthcare, LLC
Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer... 2 11/19/2018 GE Healthcare, LLC
Panda Wall Mount warmer. Infant radiant warmer 2 11/19/2018 GE Healthcare, LLC
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