Device recall
Z-0439-2014: C-Series: Clinac, Trilogy, Trilogy Tx., Novalis high energy linear accelerators…
FDA device recall · Class II · Varian Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0439-2014 |
|---|---|
| Recall event | 66764 |
| Product | C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision… |
| Product code | IYE |
| Recalling firm | Varian Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 13, 2016 |
| 510(k) numbers | K131807, K132705 |
| 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