GE HealthCare Anesthesia Systems Recall
potentially life-threatening risk in Volume Control Ventilation (VCV) modeGE Carestation Anesthesia Systems
GE HealthCare has issued a high-priority correction for certain Carestation anesthesia systems due to a potentially life-threatening risk when used in Volume Control Ventilation (VCV) mode.
Affected Devices
- Carestation 620, 650, 650c
- Carestation 750, 750c
These systems are used in hospitals and surgical settings for delivering anesthesia and ventilatory support to patients of all ages.
The Problem
In VCV mode, the devices affected may fail to ventilate properly. If this happens:
- Alarms and warnings will be triggered (e.g., bellows stop moving, “Unable to Drive Bellows” message, apnea alerts).
- If uncorrected, this can lead to serious injury or death from hypoxia (low oxygen levels).
What to Do
GE HealthCare recommends:
- Do NOT use VCV mode until the device is corrected.
- Use only:
- Pressure Control Ventilation (PCV)
- Pressure Control Ventilation Volume Guarantee (PCV-VG)
- Or manual ventilation
- Perform a Ventilation Screening Test on each system.
- Train your staff and ensure they are aware of the risk and temporary workaround.
- Return the Acknowledgement Form provided in the correction notice.
Questions?
Call GE HealthCare Service at 1-800-437-1171.
If your facility uses these systems, take immediate action to prevent harm. GE HealthCare is currently correcting the devices — no need to remove them from service if alternate modes are used safely.
Class I Correction for Homecare Bed Fire and Entrapment Risks
Medline Homecare Beds: FDA Class I Correction for Fire and Entrapment Risks Medline Industries has issued a critical safety correction involving multiple models of homecare beds following reports of overheating components, electrical hazards, and patient entrapment...
When a Small Process Failure Becomes a Patient Safety Event
What the Erbe Cryoprobe Alert Teaches Us About Modern Device Quality The FDA’s recent Early Alert regarding flexible cryoprobes manufactured by Erbe USA is a textbook example of a fundamental truth in medical device quality. That small manufacturing deviations can...
FDA Flags High-Risk Issue with Erbe Flexible Cryoprobes
FDA Flags High-Risk Issue with Erbe Flexible Cryoprobes The FDA’s Center for Devices and Radiological Health (CDRH) has issued an Early Alert regarding a potentially high-risk issue involving certain flexible cryoprobes manufactured by Erbe USA. Issue Overview Erbe...