Device recall
Z-1422-2011: Siemens brand ARTISTE MV with Artiste Digital Linear Accelerators in combination…
FDA device recall · Class II · Siemens Medical Solutions USA, Inc., Concord, CA
Key facts
| Recall number (Z-number) | Z-1422-2011 |
|---|---|
| Recall event | 57704 |
| Product | Siemens brand ARTISTE MV with Artiste Digital Linear Accelerators in combination with the Flat Panel Positioner; Part No. 8139789; Intended use: To deliver x-ray radiation for therapeutic treatment of cancer. Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Concord… |
| Product code | IYE |
| Recalling firm | Siemens Medical Solutions USA, Inc., Concord, CA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 30, 2011 |
| 510(k) numbers | K072485 |
| FEI number | 2937457 |
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