XiO RTP System The XiO RTP System is used to create treatment plans… — Class II medical device recall Z-0780-2014
Terminated recall by Elekta, Inc., reported 2014-01-29, distributed in IL, IN, LA, NJ, TX, WA, WI. When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary
| Recall number | Z-0780-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2013-11-25 |
| Classified | 2014-01-17 |
| Reported by FDA | 2014-01-29 |
| Terminated | 2014-05-13 |
| Distributed | IL, IN, LA, NJ, TX, WA, WI |
| Countries outside the US | BE, DE, IT, NL |
| Quantity | 13 |
Product
XiO RTP 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 plan set-up.
Reason for recall
When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan.
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-0780-2014. 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.