Device recall
Z-1204-2019: Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON…
FDA device recall · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Recall number (Z-number) | Z-1204-2019 |
|---|---|
| Recall event | 82605 |
| Product | Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression Plus ONCOR Avant Garde ONCOR Expression ARTISTE, ONCOR, and PRIMUS running the following: Control Console from software version 13.0.302 and higher; Control… |
| Product code | IYE |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 18, 2020 |
| 510(k) numbers | K031764, K060226, K072485, K121295, K993425 |
| 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