Oncentra Brachy 4 — Class II medical device recall Z-0050-2018
Terminated recall by Nucletron BV, reported 2017-11-01, distributed nationwide. Incorrect source step size may occur in the software plans
| Recall number | Z-0050-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nucletron BV, Veenendaal, N/A, Netherlands |
| Recall initiated | 2017-08-10 |
| Classified | 2017-10-26 |
| Reported by FDA | 2017-11-01 |
| Terminated | 2020-11-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CA, CH, CL, CN, CO, CZ, DE, DK, ES, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IS, IT, JP, KR, MA, MX, MY, NL, NO, NZ, PE, PH, PK, PL, RO, RS, RU, SA, SE, SG, SK, TH, TR, TW, UA, VN, ZA |
| Quantity | 89 customer |
| Reason classes | software |
Product
Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.
Reason for recall
Incorrect source step size may occur in the software plans
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-0050-2018. 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.