GE Medical Systems China Co., Ltd. 2025-05-07 Health critical FDA
Health · FDA · Recall #FDA-Z-1632-2025
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system. Recall
Issued May 7, 2025 · GE Medical Systems China Co., Ltd.
In May 2025, GE Medical Systems China Co., Ltd. recalled the GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system., a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
What you should do
- 1 Stop using GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system. right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact GE Medical Systems China Co., Ltd. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- GE Medical Systems China Co., Ltd.
- Category
- Health
- Recall date
- May 7, 2025
- Units affected
- Not reported
- Sold at
- Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh,
- Recall number
- FDA-Z-1632-2025
- Made in
- China
- Issuing agency
- FDA
In context
- GE Medical Systems China Co., Ltd. has 3 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.