Device recall
Z-0614-2025: GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA…
FDA device recall · Class II · GE Healthcare (China) Co., Ltd.
Key facts
| Recall number (Z-number) | Z-0614-2025 |
|---|---|
| Recall event | 95704 |
| Product | GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed, Elite/BrightSpeed Elite Select), Non-EU: BrightSpeed Elite, BrightSpeed Elite Select; X-ray/computed tomography system |
| Product code | JAK |
| Recalling firm | GE Healthcare (China) Co., Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K052855 |
| FEI number | 3008284470 |
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