GE HealthCare Carestation Devices - Correction for Ineffective Ventilation in VCV Mode (FDA Class I Recall)

FDA issued a Class I recall for GE HealthCare Carestation 620/650/650c and 750/750c Anesthesia Systems due to risk of ineffective ventilation in VCV mode.

Source updated: Jun 5, 2026

Primary source: https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/anesthesia-delivery-systems-recall-ge-healthcare-issues-correction-certain-carestations-due-risk

PV Impact Brief

Urgency: HighConfidence: high

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.

Action needed

Do not use VCV mode until corrected. Use PCV or PCV-VG mode. Perform Ventilation Screening Test. Return acknowledgement form to GE HealthCare.

Relevant for: Regulatory Intelligence LeadSignal Management Lead
Processes impacted: Signal ManagementLabeling
Owner: Regulatory Intelligence Lead
Review cadence: Immediate review required; monitor for updates from GE HealthCare and FDA.

Regulatory action details

Action type: Medical Device Recall / Correction
Publication date: 2026-06-05
Safety issue: GE HealthCare is correcting certain Carestation devices due to the risk that they may not provide effective ventilation when used in Volume Control Ventilation (VCV) mode. This can lead to serious injury or death.

Affected products

Carestation 620/650/650c and 750/750c Anesthesia Systems
GE HealthCare

PV internal implications

Do not use VCV mode until corrected. Use PCV or PCV-VG mode. Perform Ventilation Screening Test. Return acknowledgement form.

View regulator source

Evidence and confidence

Confidence: highSource updated: Jun 5, 2026

https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/anesthesia-delivery-systems-recall-ge-healthcare-issues-correction-certain-carestations-due-riskUpdated June 5, 2026

Full briefing

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.

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.

View original source

Published from the Firecrawl agent regulatory extraction pipeline.

#Safety Signals #Recalls #Medical Device Recall / Correction #FDA #device_vigilance #firecrawl-agent #regulatory-extraction

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