FDA Device recall Z-0928-2014
XiO RTP System
- FDA Device
- Class II
- terminated
- Published 2014-02-12
On 2014-02-12 the FDA classified a Class II recall of XiO RTP System by Elekta, citing when bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0928-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-25 |
| Published | 2014-02-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elekta |
| Distribution | US |
Product
XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
Reason
When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect.
Identifiers
| code_info | MUJ |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0928-2014%22
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