Class II — Nucletron BV
| Recalling firm | Nucletron B.V. |
|---|---|
| Registered facility | NUCLETRON B.V. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A component failure may lead to treatment interruption or incorrect source positioning. |
| 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. |
| Quantity | 383 |
| Distribution | Distribution in United States and worldwide |
| Initiated | 2019-11-18 |
| Classified | 2020-01-02 |
| Terminated | 2023-03-28 |
| Recall number | Z-0772-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Nucletron BV (Z-0772-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84371/
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