Anesthesia System Correction: GE HealthCare Updates Use Instructions for CareStation Anesthesia Systems
This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
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.
Reason for Correction
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.
Additional FDA Resources
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 recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
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.
Date | Actions |
| 12/29/2025 | The FDA updated this communication to inform the public that this issue has been classified as a Class I Recall. |
| 12/10/2025 | The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue. |