FDA Device recall Z-1633-2025
GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002
- FDA Device
- Class I
- ongoing
- Published 2025-05-07
On 2025-05-07 the FDA classified a Class I recall of GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002 by Ge Medical Systems China, citing 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, effect….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1633-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-03-21 |
| Published | 2025-05-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems China |
| Distribution | US |
Product
GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.
Reason
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.
Identifiers
| code_info | GTIN 00840682124539, Serial Numbers: SM823250002WB, SM823250003WB, SM824100001WB, SM824100002WB, SM823080001WB, SM8230…GTIN 00840682124539, Serial Numbers: SM823250002WB, SM823250003WB, SM824100001WB, SM824100002WB, SM823080001WB, SM823080002WB, SM823250001WB, SM824380004WB, SM823140001WB, SM824410006WB, SM824410007WB, SM824410008WB, SM824380005WB, SM823460001WB, SM823460002WB. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1633-2025%22
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