Device recall
Z-0781-2024: Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary…
FDA device recall · Class II · SEDECAL SA
Key facts
| Recall number (Z-number) | Z-0781-2024 |
|---|---|
| Recall event | 93614 |
| Product | Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position. |
| Product code | KPR |
| Recalling firm | SEDECAL SA |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K012546 |
| FEI number | 3002495042 |
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