Device recall
Z-2551-2016: Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a…
FDA device recall · Class II · Merge Healthcare, Inc.
Key facts
| Recall number (Z-number) | Z-2551-2016 |
|---|---|
| Recall event | 74846 |
| Product | Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems. |
| Product code | LLZ |
| Recalling firm | Merge Healthcare, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 7, 2016 |
| 510(k) numbers | K041935 |
| 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