Focalyx Fusion

This recall is currently active, issued February 3, 2026. It was issued by Focalyx Technologies, Llc..

Company

Focalyx Technologies, Llc.

Recall Initiated

December 23, 2025

Posted

February 3, 2026

Recall Number

Z-1243-2026

Quantity

18

Firm Location

Hialeah, FL

Official Source

View on FDA website ↗

Reason for Recall

Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm is recommending stop use until device is verified/validated with Windows 11.

Distribution

Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO.

Lot / Code Info

UDI-DI: 00860003552001. Software Versions: 1.3, 1.5, 1.6. Serial Numbers: IF-FF-B-1-22080504, IF-FF-B-1-TPAA998118, IF-FF-B-1-351238, IF-FF-B-1-TPAB081335, IF-FF-B-1-22080508, IF-FF-B-1-TPAB200331, IF-FF-B-1-TPAB200333, IF-FF-B-1-TPAC505383, IF-FF-B-1-TPAB200348, IF-FF-B-1-TPAB540364, IF-FF-B-1-S5ARQL009253NYZ, IF-FF-B-1-SCARQL0014096YZ, IF-FF-B-1-TPAB532163, IF-FF-B-1-SCARQL00136033KK, IF-FF-B-1-TPAB540359, IF-FF-B-1-TPAB081326, IF-FF-B-1-22080505, IF-FF-B-1-TPAB081324

Root Cause

Software change control

Action Taken

On 12/23/2025, correction notices started being emailed to customers informing them of the following: You will be contacted to schedule installation of the new version. An IFU will be provided at time of installation. Complete and return the response form via email to corporate@focalyx.com If there are any questions, contact the firm at: focalyxtechnologies.com/contact, support@focalyxtechnologies.com, (888) 636 2259, (Sel. 3 Technical Support)