Device recall
Z-1435-2011: IMPAX CV Results Manager/Results Manager Administration Tool The IMPAX…
FDA device recall · Class II · AGFA Corp.
Key facts
| Recall number (Z-number) | Z-1435-2011 |
|---|---|
| Recall event | 57820 |
| Product | IMPAX CV Results Manager/Results Manager Administration Tool The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting. The suite is comprised of modular software that runs on industry standard… |
| Product code | LLZ |
| Recalling firm | AGFA Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 13, 2011 |
| 510(k) numbers | K050228 |
| 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