XiO RTP System — Class II medical device recall Z-0928-2014
Terminated recall by Elekta, Inc., reported 2014-02-12, distributed nationwide. When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report
| Recall number | Z-0928-2014 |
|---|---|
| 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 | 2014-02-04 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2015-12-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, BG, BH, BR, CA, CL, CN, CR, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HR, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LT, LV, MA, MT, MX, MY, NZ, PE, PH, PK, PL, PT, RO, RS, RU, SA, SG, SI, SK, TH, TR, TW, UA, VE, VN, ZA |
| Quantity | 1,424 |
Product
XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
Reason for recall
When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect.
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-0928-2014. 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.