Nucletron BV recalls There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy a…

Recall date

November 18, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0772-2020

FDA classification

Class II

Brand / firm

Nucletron BV

Sold / distributed

Distribution in United States and worldwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.