GE HealthCare Anesthesia Systems Recall

potentially life-threatening risk in Volume Control Ventilation (VCV) mode

GE 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:

  1. Do NOT use VCV mode until the device is corrected.
  2. Use only:
    • Pressure Control Ventilation (PCV)
    • Pressure Control Ventilation Volume Guarantee (PCV-VG)
    • Or manual ventilation
  3. Perform a Ventilation Screening Test on each system.
  4. Train your staff and ensure they are aware of the risk and temporary workaround.
  5. 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.

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