BEUDAMED
    FDA Enforcement Class II Terminated

    Synapse PACS Software Version 5.6.1 - 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-0282-2021 · Reported October 28, 2020

    Enforcement

    Recall Number
    Z-0282-2021
    Event ID
    86494
    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
    October 28, 2020
    Initiation Date
    September 11, 2020
    Classification Date
    October 22, 2020
    Termination Date
    November 17, 2021
    Address
    81 Hartwell Ave Ste 300, N/A, Lexington, MA, 02421-3160, United States

    Description

    Synapse PACS Software Version 5.6.1 - 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

    FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not affected.

    Code Info

    Synapse Software Version 5.6.1

    Distribution

    US Nationwide distribution including in the state of Minnesota.

    Quantity

    1