Device recall
Z-1161-2012: Eclipse Treatment Planning System, versions 7.3, 8.0, 8.1, 8.2, 8.6, 8.9 and…
FDA device recall · Class II · Varian Medical Systems, Inc. Oncology Systems
Key facts
| Recall number (Z-number) | Z-1161-2012 |
|---|---|
| Recall event | 61198 |
| Product | Eclipse Treatment Planning System, versions 7.3, 8.0, 8.1, 8.2, 8.6, 8.9 and 10.0; Model H48 Varian Medical Systems, Palo Alto, CA. Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS… |
| Product code | MUJ |
| Recalling firm | Varian Medical Systems, Inc. Oncology Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 15, 2014 |
| 510(k) numbers | K102011 |
| 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