Focalyx Fusion

Company

Focalyx Technologies, Llc.

Recall Initiated

December 23, 2025

Posted

February 3, 2026

Recall Number

Z-1243-2026

Quantity

18

Firm Location

Hialeah, FL

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)