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Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M1

Recall date: 2026-06-24 · Source: FDA_DEVICE
Brand / Firm
Datex-Ohmeda Inc
Product
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.
Reason for recall
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.
Units affected
550 (367 US; 183 OUS)
Description
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.
View official recall notice →