Device recall
Z-1070-2013: IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound…
FDA device recall · Class II · AGFA Corp.
Key facts
| Recall number (Z-number) | Z-1070-2013 |
|---|---|
| Recall event | 64656 |
| Product | IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease. |
| Product code | LLZ |
| Recalling firm | AGFA Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 9, 2014 |
| 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