Device recall
Z-2413-2024: Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray…
FDA device recall · Class II · Palodex Group Oy
Key facts
| Recall number (Z-number) | Z-2413-2024 |
|---|---|
| Recall event | 95017 |
| Product | Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals. |
| Product code | OAS |
| Recalling firm | Palodex Group Oy |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K163423 |
| FEI number | 3005383085 |
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