Device recall
Z-3245-2018: DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General…
FDA device recall · Class II · Agfa N.V.
Key facts
| Recall number (Z-number) | Z-3245-2018 |
|---|---|
| Recall event | 81046 |
| Product | DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal… |
| Product code | KPR |
| Recalling firm | Agfa N.V. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 23, 2020 |
| 510(k) numbers | K112670 |
| 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