Device recall
Z-1487-2013: AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for…
FDA device recall · Class II · AGFA Corp.
Key facts
| Recall number (Z-number) | Z-1487-2013 |
|---|---|
| Recall event | 65223 |
| Product | AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and… |
| Product code | IZL |
| Recalling firm | AGFA Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 31, 2014 |
| 510(k) numbers | K103597 |
| FEI number | 3001236302 |
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