BEUDAMED
    FDA Recall Terminated

    VidiStar(TM) PACS & DICOM Viewer Software system

    Recall: Z-2992-2018 · Initiated August 28, 2018

    Recall

    Recall Number
    Z-2992-2018
    Event Number
    80896
    Firm
    Hitachi Healthcare Americas Corp Informatics Division
    FEI Number
    3019837913
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    August 28, 2018
    Terminated
    February 11, 2021
    Address
    204 Westfield St, Greenville, SC, 29601-1833

    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.

    Action

    The firm initiated the recall by email on 08/28/2018. The firm will be removing the 3rd party software from the interface and replacing it with new software and notify the affected customers when the action is completed.

    Distribution

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

    Quantity

    12 units