Early Alert: Infant Resuscitation System Issue from GE HealthCare

Published: 06/05/2026

Sources:
  • Food and Drug Administration
Relevant To:
  • Rural Emergency Hospitals,
  • Critical Access Hospitals,
  • Hospitals

GE HealthCare has issued a letter to affected customers recommending Infant Resuscitation Systems and Warmers with a M1091607-R blender be corrected prior to continued use.

GE HealthCare stated that the air-oxygen blender knob shaft on certain integrated and stand-alone Resuscitation systems 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 …

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