Device recall
Z-1809-2009: Varis, Aria Radiation Oncology - Version 8.1.15, 8.5.11, and 8.6.07, Model…
FDA device recall · Class II · Varian Medical Systems Oncology Systems
Key facts
| Recall number (Z-number) | Z-1809-2009 |
|---|---|
| Recall event | 52654 |
| Product | Varis, Aria Radiation Oncology - Version 8.1.15, 8.5.11, and 8.6.07, Model number HIT-INFSYS, Manufactured by Varian Medical Systems Inc., Palo Alto, CA The Varis RV function is designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by… |
| Product code | IYE |
| Recalling firm | Varian Medical Systems Oncology Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 23, 2011 |
| 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