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Early Alert: Anesthesia System Issue from GE HealthCare
The FDA is aware that GE HealthCare has issued a letter to affected customers recommending updated use instructions for certain Carestation 600 and 700 series Anesthesia Systems due to the potential for an unexpected shutdown if the AC mains power is unplugged or experiences a loss of power. Anesthesia systems operate on battery power in the event of a power failure where there is no continuous backup emergency power. If AC power is interrupted, these certain Carestation 600 and 700 Series Anesthesia Systems will not automatically switch over to the battery supply mode and will reboot once power is restored. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.
If this situation is not identified and addressed by the user, the loss of ventilation may be life threatening.
As of November 26, 2025, GE HealthCare has not reported any serious injuries or deaths associated with this issue.
The FDA has become aware of a potentially high-risk issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact GE HealthCare at 1-800-437-1171.
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