# FDA recall Z-0772-2020

> **Nucletron BV** · Class II · device recall initiated 2019-11-18.

## 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.

## Distribution

Distribution in United States and worldwide

## Key facts

- **Recall number:** Z-0772-2020
- **Recalling firm:** Nucletron BV
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-18
- **Report date:** 2020-01-08
- **Termination date:** 2023-03-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Veenendaal, N/A, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0772-2020

## Citation

> AI Analytics. FDA recall Z-0772-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0772-2020. Source: US FDA. Licensed CC0.

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