FDA-Device2026-06-24Class IPROCESSING DEFECT

Datex-Ohmeda Panda Infant Warmer recalled for oxygen delivery error risk

OTHERNationwide distribution

Datex-Ohmeda Panda warmer recalled for oxygen concentration error

A blender component in certain Datex-Ohmeda Panda Freestanding Warmers can loosen over time, causing the device to deliver oxygen at a concentration that does not match the setting the user selected. This can result in infants receiving too much or too little oxygen, potentially causing harm.

  • Check if your Panda warmer has a service blender M1091607-R installed during recent preventive maintenance.
  • If affected, contact Datex-Ohmeda immediately for inspection and correction of the blender component.
  • Do not operate the warmer if you suspect the blender knob is loose or if oxygen delivery seems inconsistent with your settings.
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
Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 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-2359-2026

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