FDA published a Class I recall for GE HealthCare Carestation Anesthesia Systems on June 5, 2026, based on a device correction initiated March 21, 2025.
The defect can cause failure of ventilation leading to hypoxia and death if VCV mode is used without correction.
Do not use VCV mode until corrected. Use PCV or PCV-VG mode. Perform Ventilation Screening Test. Return acknowledgement form to GE HealthCare.
Regulatory Intelligence Lead
Immediate review required; monitor for updates from GE HealthCare and FDA.
Do not use VCV mode until corrected. Use PCV or PCV-VG mode. Perform Ventilation Screening Test. Return acknowledgement form.
Do not use VCV mode until corrected. Use PCV or PCV-VG mode. Perform Ventilation Screening Test. Return acknowledgement form to GE HealthCare.
GE HealthCare is correcting certain Carestation devices (620, 650, 650c, 750, 750c) due to risk of ineffective ventilation when used in Volume Control Ventilation (VCV) mode. The FDA has identified this as a Class I recall. Users are instructed not to use VCV mode until correction; instead use PCV or PCV-VG mode, perform Ventilation Screening Test, and return acknowledgement form. No serious injuries or deaths reported yet.
What changed: FDA published a Class I recall for GE HealthCare Carestation Anesthesia Systems on June 5, 2026, based on a device correction initiated March 21, 2025.
Why it matters: The defect can cause failure of ventilation leading to hypoxia and death if VCV mode is used without correction.
Practical implication: Do not use VCV mode until corrected. Use PCV or PCV-VG mode. Perform Ventilation Screening Test. Return acknowledgement form to GE HealthCare.
Published from the Firecrawl agent regulatory extraction pipeline.
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