Device recall
Z-2056-2019: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage…
FDA device recall · Class II · Agfa N.V.
Key facts
| Recall number (Z-number) | Z-2056-2019 |
|---|---|
| Recall event | 83400 |
| Product | AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal… |
| Product code | JAA |
| Recalling firm | Agfa N.V. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 3, 2020 |
| 510(k) numbers | K180589 |
| FEI number | 3001556265 |
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