Device recall
Z-0516-2012: Portal Vision, R-Arm with 4D Integrated Treatment Console; Varian Medical…
FDA device recall · Class II · Varian Medical Systems, Inc. Oncology Systems
Key facts
| Recall number (Z-number) | Z-0516-2012 |
|---|---|
| Recall event | 60684 |
| Product | Portal Vision, R-Arm with 4D Integrated Treatment Console; Varian Medical Systems. Palo Alto, CA. The Portal Vision device is used for verification of the treatment field and shielding block in relation to anatomical landmarks in radiotherapy treatment. Portal Vision will also allow for verification… |
| Product code | IYE |
| Recalling firm | Varian Medical Systems, Inc. Oncology Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 6, 2014 |
| 510(k) numbers | K091209 |
| 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