Device recall
Z-0472-2023: ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1…
FDA device recall · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Recall number (Z-number) | Z-0472-2023 |
|---|---|
| Recall event | 91182 |
| Product | ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. |
| Product code | IYE |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K142434 |
| 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