Reported Dec 24, 2025 · Ongoing
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222;…
GE Medical Systems China Co., Ltd.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems China Co., Ltd. · Dev. Zone · Wuxi · N/A
Is this the product you have?
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
7 of 7 products
| Model / number | Barcodes | Product as published |
|---|---|---|
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 | — |
- Lot codes and dates
18 of 18 products
Products covered by this recall Model / number Barcodes Product as published 00195278626301REF 1012-9620-222 00840682103985REF 1012-9620-000 00195278439536REF 1012-9620-200 00195278626158REF 1012-9620-202 00195278626561REF 1012-9620-212 00195278626592REF 1012-9650-222 00840682103947REF 1012-9650-000 00195278439529REF 1012-9650-200 00195278626585REF 1012-9650-202 00195278625687REF 1012-9650-212 00195278625953REF 1012-9655-202 00840682124546REF 1012-9620-002 00195278569677REF 1012-9620-012 00840682124560REF 1012-9650-002 00195278569684REF 1012-9650-012 00840682103954REF 1012-9655-000 00840682124539REF 1012-9655-002 00195278439543.00195278439543REF 1012-9655-200 - Amount recalled
- 1277 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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