BEUDAMED
    FDA Enforcement Class II Terminated

    Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities

    Recall: Z-0073-2017 · Reported October 19, 2016

    Enforcement

    Recall Number
    Z-0073-2017
    Event ID
    75192
    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 19, 2016
    Initiation Date
    September 15, 2016
    Classification Date
    October 12, 2016
    Termination Date
    February 20, 2019
    Address
    419 West Ave, N/A, Stamford, CT, 06902-6343, United States

    Description

    Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities

    Reason

    Image data for a patients image may not be correct

    Code Info

    Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx

    Distribution

    US Nationwide Distribution.

    Quantity

    251 units