Device recall
Z-1154-2024: The device is an X-ray system that is capable of radiographic and fluoroscopic…
FDA device recall · Class II · Canon Medical System, USA, INC.
Key facts
| Recall number (Z-number) | Z-1154-2024 |
|---|---|
| Recall event | 93844 |
| Product | The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and… |
| Product code | OWB |
| Recalling firm | Canon Medical System, USA, INC. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K210900 |
| FEI number | 2020563 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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