Device recall
Z-1462-2024: Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray…
FDA device recall · Class II · Agfa N.V.
Key facts
| Recall number (Z-number) | Z-1462-2024 |
|---|---|
| Recall event | 94143 |
| Product | Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300 and A5411/ 0400 |
| Product code | IZL |
| Recalling firm | Agfa N.V. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K103597 |
| 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