Device recall
Z-0591-2012: Agfa Computed Radiography Systems with DX-G Digitizer. DX-G Digitizers haved the…
FDA device recall · Class II · AGFA Corp.
Key facts
| Recall number (Z-number) | Z-0591-2012 |
|---|---|
| Recall event | 60625 |
| Product | Agfa Computed Radiography Systems with DX-G Digitizer. DX-G Digitizers haved the same intended use as the predicate devices. they are intended to use in providing diagnostic images to aid the physician with diagnosis. DX-G Digitizers provide the ability to use both standand needle phosphor image… |
| Product code | MQB |
| Recalling firm | AGFA Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 11, 2012 |
| 510(k) numbers | K092238 |
| 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