Device recall
Z-0283-2016: IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX…
FDA device recall · Class II · AGFA Healthcare Corp.
Key facts
| Recall number (Z-number) | Z-0283-2016 |
|---|---|
| Recall event | 72411 |
| Product | IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed. |
| Product code | LLZ |
| Recalling firm | AGFA Healthcare Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 15, 2020 |
| 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