Device recall
Z-1081-2014: RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user…
FDA device recall · Class II · Elekta, Inc.
Key facts
| Recall number (Z-number) | Z-1081-2014 |
|---|---|
| Recall event | 67217 |
| Product | RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical… |
| Product code | IYE |
| Recalling firm | Elekta, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 13, 2015 |
| 510(k) numbers | K982713 |
| FEI number | 1037831 |
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