Device recall
Z-1502-2020: AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic…
FDA device recall · Class II · Agfa N.V.
Key facts
| Recall number (Z-number) | Z-1502-2020 |
|---|---|
| Recall event | 85028 |
| Product | AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications |
| Product code | IZF |
| Recalling firm | Agfa N.V. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 30, 2023 |
| 510(k) numbers | K183275 |
| FEI number | 3001556265 |
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