BEUDAMED
    FDA Enforcement Class II Terminated

    Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras.

    Recall: Z-0636-2021 · Reported December 23, 2020

    Enforcement

    Recall Number
    Z-0636-2021
    Event ID
    86737
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Kowa Optimed Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 23, 2020
    Initiation Date
    November 3, 2020
    Classification Date
    December 17, 2020
    Termination Date
    December 6, 2022
    Address
    20001 S Vermont Ave, N/A, Torrance, CA, 90502-1326, United States

    Description

    Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras.

    Reason

    It has been determined that the software distributed with the retinal camera may delete patient information. Specifically, if multiple IDs are delated at the same time, their is a potential for all patient information to be deleted. This could result in delay of treatment.

    Code Info

    Serial Numbers: 32168900007, 32168900008, 32168900009, 32168900010, 32168900011, 32168900019, 32168900020, 32168900021, 32168900022, 32168900025, 32168900035, 32168900036, 32168900037, 32168900044, 32168900045, 32169000052, 32169000144, 32169000145, 32169000152, 32169000153, 32169000166, 32169000167, 32169000168

    Distribution

    US Nationwide distribution including in the states of NY, WA, TX, CT, MA, ID, IL, MI.

    Quantity

    N/A