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.

Affected Product

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:

Product

Reference Number

UDI
Carestation 610 A1 1012-9620-222 00195278626301
Carestation 620 A1 1012-9620-000 00840682103985
Carestation 620 A1 1012-9620-200 00195278439536
Carestation 620 A1 1012-9620-202 00195278626158
Carestation 620 SE A1  1012-9620-212  00195278626561
Carestation 630 A1 1012-9650-222  00195278626592
Carestation 650 A1 1012-9650-000 00840682103947
Carestation 650 A1 1012-9650-200  00195278439529
Carestation 650 A1 1012-9650-202 00195278626585
Carestation 650 SE A1 1012-9650-212 00195278625687
Carestation 650c A1 1012-9655-202 00195278625953
Carestation 750 A1 1012-9750-000 00840682145596
Carestation 750 A2 1012-9750-002 00840682146470
Carestation 750c A1 1012-9755-000 00840682146425

In addition to the products listed above, the affected product could be installed as a spare part with the following products:

Product 

Reference Number

UDI
Carestation 620 A2 1012-9620-002 00840682124546
Carestation 620 SE A2 1012-9620-012 00195278569677
Carestation 650 A2 1012-9650-002 00840682124560
Carestation 650 SE A2 1012-9650-012 00195278569684
Carestation 650c A1 1012-9655-000 00840682103954
Carestation 650c A2  1012-9655-002 00840682124539
Carestation 650c A1 1012-9655-200 00195278439543
Carestation 750c A2 1012-9755-002 00840682146463

What to Do

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.

Check this web page 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.

Reason for Early Alert

GE HealthCare has become aware of the potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards if the AC mains power is unplugged or in the event of an AC mains power failure.

Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the Carestation 600 and 700 Series Anesthesia Systems will not automatically switch over to the battery supply mode and will reboot when 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.

Device Use

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.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact GE HealthCare at 1-800-437-1171.

Unique Device Identifier (UDI)  

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.  

How do I report a problem?  

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.