FDA recall Z-0772-2020

Nucletron BV · Class II · device

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

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

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