Device recall
Z-2136-2008: Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic…
FDA device recall · Class III · AGFA Corp.
Key facts
| Recall number (Z-number) | Z-2136-2008 |
|---|---|
| Recall event | 48462 |
| Product | Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic conventional and mammography images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable. |
| Product code | LMC |
| Recalling firm | AGFA Corp. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 10, 2008 |
| 510(k) numbers | K072680 |
| FEI number | 3001236302 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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