Device recall
Z-1494-2012: Siemens-branded ONCOR" or PRIMUS" linear accelerator with an OPTIVUE" or…
FDA device recall · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Recall number (Z-number) | Z-1494-2012 |
|---|---|
| Recall event | 61578 |
| Product | Siemens-branded ONCOR" or PRIMUS" linear accelerator with an OPTIVUE" or MVision" imaging system; Model Numbers: ONCOR Expression 7360717, ONCOR Impression Plus 5857912, ONCOR Avant Garde 5863472, PRIMUS HI 4504200; ARTISTE/ONCOR/PRIMUS systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS… |
| Product code | IYE |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 17, 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