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

Recalled January 8, 2020 · FDA recall Z-0772-2020 · Nucletron BV

Hazard

A component failure may lead to treatment interruption or incorrect source positioning. · FDA Class II

Units

383

Sold at

Distribution in United States and worldwide

Description

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.

Manufacturer(s)

Nucletron BV

Made in

Netherlands

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →