Device recall: GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
Class I FDA enforcement event 96634. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
GE Medical Systems China Co., Ltd. started this device recall on 21 Mar 2025. The firm address in the FDA record is in Wuxi. FDA put the recall in Class I. FDA event 96634 has 15 product records. The first FDA enforcement report date is 7 May 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil,…
Recalling firm
GE Medical Systems China Co., Ltd., Wuxi, China.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
15 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1624-2025 | GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems | 2298 units | Class I | Ongoing | 7 May 2025 |
| Z-1625-2025 | GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system. | 1483 units | Class I | Ongoing | 7 May 2025 |
| Z-1626-2025 | GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system. | 27 units | Class I | Ongoing | 7 May 2025 |
| Z-1627-2025 | GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system. | 383 units | Class I | Ongoing | 7 May 2025 |
| Z-1628-2025 | GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system. | 4036 units | Class I | Ongoing | 7 May 2025 |
| Z-1629-2025 | GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system. | 815 units | Class I | Ongoing | 7 May 2025 |
| Z-1630-2025 | GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system. | 1 unit | Class I | Ongoing | 7 May 2025 |
| Z-1631-2025 | GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system. | 648 units | Class I | Ongoing | 7 May 2025 |
| Z-1632-2025 | GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system. | 69 units | Class I | Ongoing | 7 May 2025 |
| Z-1633-2025 | GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system. | 15 units | Class I | Ongoing | 7 May 2025 |
| Z-1634-2025 | GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system. | 19 units | Class I | Ongoing | 7 May 2025 |
| Z-1635-2025 | GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system. | 4358 units | Class I | Ongoing | 7 May 2025 |
| Z-1636-2025 | GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system. | 217 units | Class I | Ongoing | 7 May 2025 |
| Z-1637-2025 | GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system. | 74 units | Class I | Ongoing | 7 May 2025 |
| Z-1638-2025 | GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system. | 5 units | Class I | Ongoing | 7 May 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2025
- 945
- Share of these events in Class I
- 13%
- Product records in this event
- 15Median of the firm: 2
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 21 Apr 2026 | MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph | Device | Class II | 1 |
| 14 Nov 2025 | GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Care | Device | Class I | 3 |
| 16 May 2025 | GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system | Device | Class II | 2 |
| 8 Sep 2023 | F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms) | Device | Class II | 1 |
| 24 Jul 2018 | GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems | Device | Class II | 3 |
| 11 Oct 2017 | Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 | Device | Class II | 2 |
Official channels
- FDA enforcement report Z-1624-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 96634. https://recallregister.com/fda/i/96634/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil,…
- What quantity of product is in FDA event 96634?
- The event has 15 product records. The first record gives this quantity:
2298 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 13% of the 945 device events that started in 2025 are in Class I.