publicFDA · USA · Updated Jun 5, 2026
GE HealthCare Infant Resuscitation System Air-Oxygen Blender Issue
Identify and remove affected devices from use until corrected; if use is necessary, follow additional precautions provided in the GE HealthCare customer letter.
Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Early Alert
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