BEUDAMED
    FDA Recall Open, Classified

    ZVU Functional GI Software, REF: ZVU-3

    Recall: Z-2521-2023 · Initiated July 25, 2023

    Recall

    Recall Number
    Z-2521-2023
    Event Number
    92854
    Firm
    Diversatek Healthcare
    FEI Number
    2023374
    Product Code
    FFX
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    July 25, 2023
    Posted
    September 7, 2023
    Address
    9150 Commerce Center Cir, Ste 500, Highlands Ranch, CO, 80129-1563

    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.

    Action

    Starting on 7/25/23 recall notices were mailed and emailed to customers asking them to do the following: 1) Discard affected product. 2) Contact customer service 1-800-558-6408 for replacement. 3) Complete and return the acknowledgement and receipt form.

    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