Device recall
Z-2243-2011: ARTISTE, ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and…
FDA device recall · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Recall number (Z-number) | Z-2243-2011 |
|---|---|
| Recall event | 58533 |
| Product | ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 system; Therapist Express Basic, syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS. The ONCOR and PRIMUS may be updated to utilize the RTT v4.x software. Distributed by Siemens, Healthcare, Concord, CA… |
| Product code | IYE |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 30, 2012 |
| 510(k) numbers | K060226, K993425 |
| 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