Device recall
Z-0805-2016: Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model…
FDA device recall · Class II · Varian Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0805-2016 |
|---|---|
| Recall event | 73092 |
| Product | Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with… |
| Product code | MUJ |
| Recalling firm | Varian Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 25, 2017 |
| 510(k) numbers | K152393 |
| 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