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FDA-Device2026-06-24Class IPROCESSING DEFECT

Datex-Ohmeda Giraffe and Panda warmers recalled for oxygen delivery malfunction risk

Datex-Ohmeda
OTHERNationwide distribution

Datex-Ohmeda infant warmers recalled for oxygen delivery risk

A component in certain Giraffe and Panda warming systems can loosen during maintenance, causing the device to deliver oxygen at a concentration different from what the clinician set. This can result in too much oxygen (hyperoxia) or too little oxygen (hypoxia) being delivered to the patient.

  • Check if your device has the affected service blender component (M1091607-R) installed during recent maintenance
  • If you have one of the listed serial numbers, contact Datex-Ohmeda for instructions before using the device
  • Do not operate the warmer with the affected component until you receive guidance from the manufacturer
Hazard

Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.

Sold states
Pending
Affected count
550 (367 US; 183 OUS)
Manufactured in
3114 N Grandview Blvd, Waukesha, WI, United States
Products
Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M1118179, M1112198 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2358-2026

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