BEUDAMED
    FDA Enforcement Class II Terminated

    CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179

    Recall: Z-0826-2022 · Reported April 6, 2022

    Enforcement

    Recall Number
    Z-0826-2022
    Event ID
    89715
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Diagnos Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 6, 2022
    Initiation Date
    January 11, 2022
    Classification Date
    March 25, 2022
    Termination Date
    June 18, 2024
    Address
    7005 Taschereau Blvd Suite 265, N/A, Brossard, N/A, N/A, Canada

    Description

    CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179

    Reason

    Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version.

    Code Info

    Software Version 4.7.2

    Distribution

    US: CA

    Quantity

    1