Nucletron BV: Medical Device Recall in 2020 - (Recall #: Z-0772-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 18, 2019

Date Posted: January 8, 2020

Recall Number: Z-0772-2020

Event ID: 84371

Reason for Recall:

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

Status: Terminated

Product Quantity: 383

Code Information:

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

Distribution Pattern:

Distribution in United States and worldwide

Voluntary or Mandated:

Voluntary: Firm initiated