Device recall
Z-0990-2017: Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart…
FDA device recall · Class II · Varian Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0990-2017 |
|---|---|
| Recall event | 76018 |
| Product | Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is… |
| Product code | IYE |
| Recalling firm | Varian Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 12, 2017 |
| 510(k) numbers | K141283 |
| 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