BEUDAMED
    FDA Enforcement Class II Terminated

    IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices without controlling or altering the functions and parameters of any medical devices or through computerized networks.

    Recall: Z-1138-2019 · Reported April 24, 2019

    Enforcement

    Recall Number
    Z-1138-2019
    Event ID
    82322
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Topcon Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2019
    Initiation Date
    March 6, 2019
    Classification Date
    April 12, 2019
    Termination Date
    July 17, 2019
    Address
    111 Bauer Dr, N/A, Oakland, NJ, 07436-3123, United States

    Description

    IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices without controlling or altering the functions and parameters of any medical devices or through computerized networks.

    Reason

    When a patient is selected in the patient data and another patient is selected prior to the display of the primary patient's thumbnails is completed, then the primary patient's thumbnails are displayed with secondary patient's identification information such as name, patient's ID, etc. on the monitor screen of the PC used.

    Code Info

    System Version 1.53

    Distribution

    Nationwide

    Quantity

    450 units