Device recall
Z-2567-2014: C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy…
FDA device recall · Class II · Varian Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-2567-2014 |
|---|---|
| Recall event | 68627 |
| Product | C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended… |
| Product code | IYE |
| Recalling firm | Varian Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 20, 2018 |
| FEI number | 2916710 |
At a glance
- None 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