FDA Device recall Z-1197-2014
XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brac…
- FDA Device
- Class II
- terminated
- Published 2014-03-19
On 2014-03-19 the FDA classified a Class II recall of XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brac… by Elekta, citing dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1197-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-17 |
| Published | 2014-03-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elekta |
| Distribution | AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV, WY |
Product
XiO RPT 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 distributions within a patient for a given treatment.
Reason
Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs.
Identifiers
| code_info | Versions 4.1 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-1197-2014%22
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