Device recall
Z-2685-2016: RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI…
FDA device recall · Class II · Merge Healthcare, Inc.
Key facts
| Recall number (Z-number) | Z-2685-2016 |
|---|---|
| Recall event | 74924 |
| Product | RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format. |
| Product code | LLZ |
| Recalling firm | Merge Healthcare, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 15, 2019 |
| 510(k) numbers | K053281 |
| 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