Device recall
Z-1628-2025: GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia…
FDA device recall · Class I · GE Medical Systems China Co., Ltd.
Key facts
| Recall number (Z-number) | Z-1628-2025 |
|---|---|
| Recall event | 96634 |
| Product | GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system. |
| Product code | BSZ |
| Recalling firm | GE Medical Systems China Co., Ltd. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K151570 |
| FEI number | 3003513129 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database