Device recall
Z-1069-2013: IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the…
FDA device recall · Class II · AGFA Corp.
Key facts
| Recall number (Z-number) | Z-1069-2013 |
|---|---|
| Recall event | 64654 |
| Product | IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease… |
| Product code | LLZ |
| Recalling firm | AGFA Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 1, 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