Reported Dec 24, 2025 · Ongoing
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000;…
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?
4 of 4 products
| Model / number | Product as published |
|---|---|
1012-9750-000 | GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1 |
1012-9750-002 | Carestation 750 A2 |
1012-9755-000 | Carestation 750c A1 |
1012-9755-002 | Products for which affected PMB can be used as a spare part: Carestation 750c A2 |
- Lot codes and dates
- REF 1012-9750-000GTIN 00840682145596
- REF 1012-9750-002GTIN 00840682146470
- REF 1012-9755-000GTIN 00840682146425
- REF 1012-9755-002GTIN 00840682146463
- Amount recalled
- 888 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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