BEUDAMED
    FDA Enforcement Class II Ongoing

    Focalyx Fusion

    Recall: Z-1243-2026 · Reported February 11, 2026

    Enforcement

    Recall Number
    Z-1243-2026
    Event ID
    98137
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Focalyx Technologies, LLC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 11, 2026
    Initiation Date
    December 23, 2025
    Classification Date
    February 3, 2026
    Address
    2140 W 68th St Ste 204, N/A, Hialeah, FL, 33016-1815, United States

    Description

    Focalyx Fusion

    Reason

    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.

    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

    Distribution

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

    Quantity

    18