BEUDAMED
    FDA Enforcement Class II Terminated

    FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.

    Recall: Z-0918-2021 · Reported February 3, 2021

    Enforcement

    Recall Number
    Z-0918-2021
    Event ID
    87083
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 3, 2021
    Initiation Date
    December 11, 2020
    Classification Date
    January 22, 2021
    Termination Date
    November 17, 2021
    Address
    81 Hartwell Ave Ste 300, Lexington, MA, 02421-3160, United States

    Description

    FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.

    Reason

    The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user.

    Code Info

    Versions 7.0.0 and 7.0.1

    Distribution

    US Nationwide distribution in the state of MD.

    Quantity

    1 unit