Device recall
Z-2379-2016: Merge PACS software. Product was distributed under the AMICAS label, Brighton…
FDA device recall · Class II · Merge Healthcare, Inc.
Key facts
| Recall number (Z-number) | Z-2379-2016 |
|---|---|
| Recall event | 74773 |
| Product | Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI. |
| Product code | LLZ |
| Recalling firm | Merge Healthcare, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 5, 2020 |
| 510(k) numbers | K082144 |
| FEI number | 1000116130 |
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