XiO Radiation Treatment Planning System — Class II medical device recall Z-0130-2016
Terminated recall by Elekta, Inc., reported 2015-10-28, distributed in AK, AL, AZ, CA, CO, CT, DC, FL…. Incorrect Treatment Delivery Using Third Party Fixed Wedges.
| Recall number | Z-0130-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2015-08-31 |
| Classified | 2015-10-16 |
| Reported by FDA | 2015-10-28 |
| Terminated | 2021-09-15 |
| Distributed | 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 |
| Countries outside the US | AR, AT, AU, BD, BE, BH, BR, BS, CA, CH, CL, CN, CO, CY, CZ, DE, EC, EE, EG, ES, FR, GB, GR, HR, ID, IE, IL, IN, IQ, IT, JO, JP, KR, MA, MT, MX, MY, NL, NZ, PE, PH, PK, PL, PT, RO, RS, RU, SA, SG, SK, TH, TR, TW, UA, VE, VN, ZA |
| Quantity | 1,440 units |
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 for recall
Incorrect Treatment Delivery Using Third Party Fixed Wedges.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0130-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.