Device recall
Z-0910-2011: C-Series Clinac, Trilogy and Novalis Tx used for SRS treatments, Model Numbers…
FDA device recall · Class II · Varian Medical Systems Oncology Systems
Key facts
| Recall number (Z-number) | Z-0910-2011 |
|---|---|
| Recall event | 53778 |
| Product | C-Series Clinac, Trilogy and Novalis Tx used for SRS treatments, Model Numbers H14, H18, H27, H29, HCX, manufactured by Varian Medical Systems, Palo Alto, CA. Device is a radiation Therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional… |
| Product code | IYE |
| Recalling firm | Varian Medical Systems Oncology Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 24, 2012 |
| 510(k) numbers | K070094, K913119, K904364 |
| 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