Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
GE Healthcare Carestation anesthesia system Recalled by GE Medical Systems China Co., Ltd. Due to Potential unexpected shutdown of Carestation 600 and 700...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact GE Medical Systems China Co., Ltd. directly.
Affected Products
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200; Carestation 620 A1, REF 1012-9620-202; Carestation 620 SE A1, REF 1012-9620-212; Carestation 630 A1, REF 1012-9650-222; Carestation 650 A1, REF 1012-9650-000; Carestation 650 A1, REF 1012-9650-200; Carestation 650 A1, REF 1012-9650-202; Carestation 650 SE A1, REF 1012-9650-212; Carestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine Products for which affected PMB can be used as a spare part: Carestation 620 A2, REF 1012-9620-002 00840682124546 Carestation 620 SE A2, REF 1012-9620-012 00195278569677 Carestation 650 A2, REF 1012-9650-002 00840682124560 Carestation 650 SE A2, REF 1012-9650-012 00195278569684 Carestation 650c A1, REF 1012-9655-000 00840682103954 Carestation 650c A2, REF 1012-9655-002 00840682124539 Carestation 650c A1, REF 1012-9655-200 00195278439543
Quantity: 1277 units
Why Was This Recalled?
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 system will not automatically switch over to the battery supply mode and will reboot. 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About GE Medical Systems China Co., Ltd.
GE Medical Systems China Co., Ltd. has 26 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report