Device recall
Z-2194-2008: Varis Aria Radiation Oncology Version 8.1, manufactured by Varian Medical…
FDA device recall · Class II · Varian Medical Systems Oncology Systems
Key facts
| Recall number (Z-number) | Z-2194-2008 |
|---|---|
| Recall event | 48652 |
| Product | Varis Aria Radiation Oncology Version 8.1, manufactured by Varian Medical Systems, Palo Alto, CA The device is designed to assist the operator in providing accurate treatment setups for each patient by monitoring parameters and preventing the device from commencing radiation treatment plan… |
| Product code | IYE |
| Recalling firm | Varian Medical Systems Oncology Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 27, 2010 |
| 510(k) numbers | K001643 |
| FEI number | 2916710 |
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