BEUDAMED
    FDA Enforcement Class II Ongoing

    vRad PACS with Mammography

    Recall: Z-2235-2023 · Reported August 2, 2023

    Enforcement

    Recall Number
    Z-2235-2023
    Event ID
    92516
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Virtual Radiologic Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    August 2, 2023
    Initiation Date
    May 9, 2023
    Classification Date
    July 21, 2023
    Address
    11995 Singletree Ln Ste 500, N/A, Eden Prairie, MN, 55344-5349, United States

    Description

    vRad PACS with Mammography

    Reason

    The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist.

    Code Info

    (01)00862234000313(10)23.2 Build 23.2.0.117 through (01)00862234000313(10) 23.4 Build 23.4.25.1

    Distribution

    US Nationwide distribution in the states of MD, MN, TN, FL, GA, TX, OK.

    Quantity

    8 units