Food, drugs, devices › Elekta, Inc.
Device recall: XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiat
FDA enforcement event 67625 is a device recall by Elekta, Inc. of Atlanta, GA, initiated 17 Feb 2014 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 21 Jul 2015. Initiation: voluntary: firm initiated. Elekta, Inc. has 105 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Elekta, Inc., Atlanta, GA.
Reason for recall
"Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs."
Distribution
"USA including AL, AK, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NY, NC, ND, OH, OK, PA, RI, SC, TN, TX, VA, WA, WV, WI, WY, Puerto Rico and…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 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… | 1776 | Class II | Terminated | 19 Mar 2014 |
Context
Other enforcement events for Elekta, Inc.
All 105 events for Elekta, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "USA including AL, AK, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NY, NC, ND, OH, OK, PA, RI, SC, TN, TX, VA, WA, WV, WI, WY, Puerto Rico and…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Jul 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.