GE HealthCare issued updated use instructions for certain Carestation 600 and 700 series Anesthesia Systems due to the potential for an unexpected shutdown, the FDA reports.
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, according to an FDA alert.
The Carestation anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients, including neonatal, pediatric, and adult, the FDA says.
According to the FDA, 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.
The FDA reports that, 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, the FDA reports.
The FDA says GE HealthCare has not reported any serious injuries or deaths associated with this issue, as of November 26, 2025.
Affected Product
For a list of all products affected, please see the FDA website here.
FDA Recommendations
When using affected devices, always ensure the device has a secure connection to an AC mains power source. Follow the instructions below if there is a loss of AC mains power to the system leading to an unexpected system shutdown.
On November 14, 2025, GE HealthCare sent all affected customers a letter recommending the following actions:
Always ensure the device has a secure connection to an AC mains power source.
- If there is a loss of AC mains power to the system leading to an unexpected system shutdown:
- Promptly connect a self-inflating bag connected to an oxygen source to the patient’s airway appliance (e.g. endotracheal tube) and initiate ventilation. Assess oxygenation via pulse oximetry.
- Because volatile anesthetic agent delivery may transiently be disrupted, supplement with or transition to intravenous anesthetics as needed.
- Following system reboot, the system will enter pre-use check. Press “Start Anesthesia” or “Start Case” and then select the “Bypass” button to bypass the checkout. Proceed to selecting the ventilation parameters and volatile agent concentration appropriate for the patient.
- Ensure all potential users in your facility are made aware of this safety notification and the recommended actions.
The FDA recommends checking its site for updates: “The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.”
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