FDA-Device2020-01-08Class II

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.

Nucletron BV
Hazard

A component failure may lead to treatment interruption or incorrect source positioning.

Sold states
Distribution in United States and worldwide
Affected count
383
Manufactured in
Waardgelder 1, POBox 930, Veenendaal, N/A, Netherlands
Products
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.

Official notice

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

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