publicFDA · USA · Updated Jun 5, 2026
GE HealthCare Carestation Devices - Correction for Ineffective Ventilation in VCV Mode (FDA Class I Recall)
Do not use VCV mode until corrected. Use PCV or PCV-VG mode. Perform Ventilation Screening Test. Return acknowledgement form to GE HealthCare.
Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Medical Device Recall / Correction
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