Device recall
Z-1691-2016: Sedecal SA Mobile Diagnost w DR x-ray system
FDA device recall · Class II · Sedecal USA, Inc.
Key facts
| Recall number (Z-number) | Z-1691-2016 |
|---|---|
| Recall event | 74106 |
| Product | Sedecal SA Mobile Diagnost w DR x-ray system |
| Product code | IZL |
| Recalling firm | Sedecal USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 9, 2018 |
| 510(k) numbers | K111725 |
| FEI number | 1000139935 |
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