Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

There is a complaint regarding internal check cable guide mechanism Recalled by Nucletron BV Due to A component failure may lead to treatment interruption...

Date: November 18, 2019
Company: Nucletron BV
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Nucletron BV directly.

Affected Products

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.

Quantity: 383

Why Was This Recalled?

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

Where Was This Sold?

Distribution in United States and worldwide

About Nucletron BV

Nucletron BV has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report