Home / Recalls / Nucletron BV / Z-0772-2020

Z-0772-2020 Class II Terminated

Recalled by Nucletron BV — Veenendaal, N/A

Recall Details

Product Type: Devices
Report Date: January 8, 2020
Initiation Date: November 18, 2019
Termination Date: March 28, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 383

Product Description

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 Pattern

Distribution in United States and worldwide

Code Information

REF 136149A02; UDI: (01)08717213051126 (11)171127 (21)FT00340 (240)136149