Device recall
Z-1261-2018: Syngo.via software is intended to be used for viewing, manipulation…
FDA device recall · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Recall number (Z-number) | Z-1261-2018 |
|---|---|
| Recall event | 79513 |
| Product | Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. |
| Product code | LLZ |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 2, 2018 |
| 510(k) numbers | K123375 |
| FEI number | 2240869 |
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