medical Class II Updated 2020-01-08

Nucletron BV recalls There is a complaint regarding internal check cable guide me

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: REF 136149A02; UDI: (01)08717213051126 (11)171127 (21)FT00340 (240)136149
View official government recall

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