FDA Device recall Z-0130-2016
XiO Radiation Treatment Planning System
- FDA Device
- Class II
- terminated
- Published 2015-10-28
On 2015-10-28 the FDA classified a Class II recall of XiO Radiation Treatment Planning System by Elekta, citing incorrect Treatment Delivery Using Third Party Fixed Wedges.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0130-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-31 |
| Published | 2015-10-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elekta |
| Distribution | AK, AL, AZ, CA, CO, CT, DC, FL, IL, IN, KY, MA, MD, MI, MN, MO, NC, ND, NJ, NY, OH, OK, PA, PR, TN, TX, VA, WA, WI |
Product
XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
Reason
Incorrect Treatment Delivery Using Third Party Fixed Wedges.
Identifiers
| code_info | Version 4.51 and higher |
|---|
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-0130-2016%22
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