Device recall
Z-2652-2017: IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and…
FDA device recall · Class II · AGFA Healthcare Corp.
Key facts
| Recall number (Z-number) | Z-2652-2017 |
|---|---|
| Recall event | 77629 |
| Product | IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats |
| Product code | LLZ |
| Recalling firm | AGFA Healthcare Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 27, 2021 |
| 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