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Health Canada Medical devices

GE Healthcare Integrated and Stand-Alone Resuscitation systems

Issued June 1, 2026
Issue
Product GE Healthcare Integrated and Stand-Alone Resuscitation systems Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information. Audience Healthcare
Hazard description
GE HealthCare has become aware of a potential issue involving the air-oxygen blender knob shaft on certain (serial number specific) integrated and stand-alone Resuscitation systems. In some cases, the blender knob shaft can loosen, which can affect the delivered oxygen concentration. If this occurs, 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.
Reference
ID
RA-82212