BEUDAMED
    FDA Enforcement Class II Terminated

    VidiStar(TM) PACS & DICOM Viewer Software system

    Recall: Z-2992-2018 · Reported September 12, 2018

    Enforcement

    Recall Number
    Z-2992-2018
    Event ID
    80896
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hitachi Healthcare Americas Corp Informatics Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 12, 2018
    Initiation Date
    August 28, 2018
    Classification Date
    September 6, 2018
    Termination Date
    February 11, 2021
    Address
    204 Westfield St, N/A, Greenville, SC, 29601-1833, United States

    Description

    VidiStar(TM) PACS & DICOM Viewer Software system

    Reason

    The secure filesystem client software used in the interface between the Vidistar PACS and an EHR system may cause intermixed images from multiple patients showing in a single study.

    Code Info

    versions 3.10.5 and 3.10.6

    Distribution

    SC, CO, IL, AZ, MT, OH, IN, TX, GA, MA

    Quantity

    12 units