Device recall
Z-1887-2009: Agfa Impax R6.3 DB Server. Impax Systems are Picture Archiving and Communication…
FDA device recall · Class II · AGFA Corp.
Key facts
| Recall number (Z-number) | Z-1887-2009 |
|---|---|
| Recall event | 52757 |
| Product | Agfa Impax R6.3 DB Server. Impax Systems are Picture Archiving and Communication systems (PACs). PAC systems are used in the acceptance, transfer, display, storage and digital processing of medical images. Primary users are radiologists, mammographers, orthopaedists and other trained medical staff. |
| Product code | LLZ |
| Recalling firm | AGFA Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2011 |
| 510(k) numbers | K022292 |
| 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