Device recall
Z-2061-2015: IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving…
FDA device recall · Class II · AGFA Healthcare Corp.
Key facts
| Recall number (Z-number) | Z-2061-2015 |
|---|---|
| Recall event | 71606 |
| Product | IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic… |
| Product code | LLZ |
| Recalling firm | AGFA Healthcare Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 27, 2016 |
| FEI number | 3001236302 |
At a glance
- None 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