Device recall
Z-0780-2014: XiO RTP System The XiO RTP System is used to create treatment plans for any…
FDA device recall · Class II · Elekta, Inc.
Key facts
| Recall number (Z-number) | Z-0780-2014 |
|---|---|
| Recall event | 67078 |
| Product | XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose… |
| Product code | MUJ |
| Recalling firm | Elekta, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 13, 2014 |
| 510(k) numbers | K102216 |
| 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