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510(k) K123309 · FMT Warmer, Infant Radiant

GIRAFFE AND PANDA WARMERS

Applicant	Ohmeda Medical, Laurel MD, US
Decision	Substantially Equivalent, Feb 5, 2013
Received	Oct 24, 2012
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K123309

Date	Firm and product	Code	Linked 510(k)
Jun 18, 2026	Datex-Ohmeda Inc Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance. Open, Classified	FMT	None listed
Jul 11, 2019	GE Healthcare, LLC 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 m Terminated	FMT	None listed
Jul 11, 2019	GE Healthcare, LLC Panda 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 Terminated	FMT	None listed
Sep 25, 2018	GE Healthcare, LLC Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer. Terminated	FMT	None listed
Sep 25, 2018	GE Healthcare, LLC Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer. Terminated	FMT	None listed
Sep 25, 2018	GE Healthcare, LLC Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant Radiant warmer. Terminated	FMT	None listed
Sep 25, 2018	GE Healthcare, LLC Panda Wall Mount warmer. Infant radiant warmer Terminated	FMT	None listed
May 6, 2014	GE Healthcare Giraffe Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for c Terminated	FMT	None listed
May 6, 2014	GE Healthcare Panda iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used fo Terminated	FMT	None listed
May 6, 2014	GE Healthcare Panda Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring featur Terminated	FMT	None listed
May 6, 2014	GE Healthcare Panda Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature Terminated	FMT	None listed
Feb 3, 2014	GE Healthcare Giraffe Infant Warmers, part number M1118179, labeled in part * GE Healthcare 8880 Gorman Road Laurel, MD 20723www.gehealthcare.com Giraffe Infant Warmers provide infrared heat in a controlled Terminated	FMT	None listed
Feb 3, 2014	GE Healthcare Panda iRes Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part * GE Healthcare 8880 Gorman Road Laurel, MD 20723www.gehealthcare.com* Panda Terminated	FMT	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.