FDA issued an Early Alert notifying the public of a potentially high-risk device issue with GE HealthCare Infant Resuscitation Systems, recommending affected devices be corrected prior to continued use.
The issue could lead to hypoxia or hyperoxia in infant patients if the device delivers incorrect oxygen concentration.
Identify and remove affected devices from use until corrected; if use is necessary, follow additional precautions provided in the GE HealthCare customer letter.
Regulatory Intelligence Lead
as needed until resolved
Follow the instructions in the alert.
Identify and remove affected devices from use until corrected; if use is necessary, follow additional precautions provided in the GE HealthCare customer letter.
FDA issued an early alert on June 5, 2026, concerning GE HealthCare Infant Resuscitation Systems and Warmers with M1091607-R blender. The knob shaft may loosen, causing oxygen concentration mismatch and potential hypoxia or hyperoxia. No serious injuries or deaths reported as of May 20, 2026.
What changed: FDA issued an Early Alert notifying the public of a potentially high-risk device issue with GE HealthCare Infant Resuscitation Systems, recommending affected devices be corrected prior to continued use.
Why it matters: The issue could lead to hypoxia or hyperoxia in infant patients if the device delivers incorrect oxygen concentration.
Practical implication: Identify and remove affected devices from use until corrected; if use is necessary, follow additional precautions provided in the GE HealthCare customer letter.
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