There is a complaint regarding internal check cable guide mechanism… — Class II medical device recall Z-0772-2020
Terminated recall by Nucletron BV, reported 2020-01-08. A component failure may lead to treatment interruption or incorrect source positioning.
| Recall number | Z-0772-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nucletron BV, Veenendaal, N/A, Netherlands |
| Recall initiated | 2019-11-18 |
| Classified | 2020-01-02 |
| Reported by FDA | 2020-01-08 |
| Terminated | 2023-03-28 |
| Quantity | 383 |
| UPC / GTIN / UDI-DI | 08717213051126 |
| Model numbers | 136149A02 |
Product
There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This issue could cause treatment interruption or in a very unlikely scenario, incorrect source positioning and radiation treatment errors.
Reason for recall
A component failure may lead to treatment interruption or incorrect source positioning.
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-0772-2020. 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.