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Medical Device Recall / Correction

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

Relevant for: Regulatory Intelligence Lead, Signal Management Lead

verifiedRegulatory action: Medical Device Recall / Correction

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Tag: Medical Device Recall / Correction | PV Bulletin