Device recall
Z-0129-2016: Owandy Radiology I -MAX Touch 3D X-ray
FDA device recall · Class II · Villa Radiology Systems LLC
Key facts
| Recall number (Z-number) | Z-0129-2016 |
|---|---|
| Recall event | 71958 |
| Product | Owandy Radiology I -MAX Touch 3D X-ray |
| Product code | OAS |
| Recalling firm | Villa Radiology Systems LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 22, 2017 |
| 510(k) numbers | K130443 |
| FEI number | 2243757 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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