Nucletron BV Waardgelder 1 POBox 930 Veenendaal Netherlands 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

The recalling firm will send a Field Safety Notice 806-01-BTD-001 to all affected customers. The notice informs user of the specific product and version numbers affected by the issue, and any work arounds that can be used to avoid the issue. A copy of the Field Safety Notice is to be kept with the most current labeling and all personnel working with the product should be made aware of the content of the letter. Customers are instructed to complete and return the Field Safety Notice Acknowledgement form to their local Eleka representative as soon as possible and no longer than 30 days from receipt.