BEUDAMED
    FDA Enforcement Class III Ongoing

    ZVU Functional GI Software, REF: ZVU-3

    Recall: Z-2521-2023 · Reported September 13, 2023

    Enforcement

    Recall Number
    Z-2521-2023
    Event ID
    92854
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Diversatek Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 13, 2023
    Initiation Date
    July 25, 2023
    Classification Date
    September 7, 2023
    Address
    9150 Commerce Center Cir Ste 500, N/A, Highlands Ranch, CO, 80129-1563, United States

    Description

    ZVU Functional GI Software, REF: ZVU-3

    Reason

    GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.

    Code Info

    UDI-DI: 00816734022825, REV: 3.3.0, Software Version: 3.3.2109.6, Shipped between 5/4/2023 and 7/6/2023

    Distribution

    worldwide - US Nationwide distribution in the states of NJ, MN, TN, WA, KY, OR, FL, GA, NY, TX, CO, KS and the countries of Japan, Saudi Arabia.

    Quantity

    20