BEUDAMED
    FDA Recall Open, Classified

    vRad PACS with Mammography

    Recall: Z-2235-2023 · Initiated May 9, 2023

    Recall

    Recall Number
    Z-2235-2023
    Event Number
    92516
    Firm
    Virtual Radiologic Corp.
    FEI Number
    3007795813
    Product Code
    LLZ
    Status
    Open, Classified
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    May 9, 2023
    Posted
    July 21, 2023
    Address
    11995 Singletree Ln, Ste 500, Eden Prairie, MN, 55344-5349

    Description

    vRad PACS with Mammography

    Reason

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

    Action

    The firm issued an URGENT FIELD CORRECION notice to its consignees beginning on 06/28/2023 via email. The notice explained the issue, root cause, and repair of the software. It was recommended that those consignees who experienced the malfunction review the affected cases.

    Distribution

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

    Quantity

    8 units