BEUDAMED
    FDA Recall Terminated

    Synapse Version 2.2.1 and 2.3.1 software

    Recall: Z-0932-03 · Initiated May 12, 2003

    Recall

    Recall Number
    Z-0932-03
    Event Number
    26390
    Firm
    Fujifilm Medical System USA, Inc.
    FEI Number
    1000513161
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 12, 2003
    Posted
    June 12, 2003
    Terminated
    May 25, 2004
    Address
    419 West Avenue, Stamford, CT, 06902

    Description

    Synapse Version 2.2.1 and 2.3.1 software

    Reason

    Synapse Version 2.2.1 and 2.3.1 Software [Free-Hand Region] may lead to incorrect density calculations during CT scan

    Action

    FujiFilm notified users via letter notification during the week of May 12, 2003. Users wll be visited by a Regional Service Engineer to install the corrected software.

    Distribution

    Nationwide Foreign: Canada, Germany, Israel, Japan

    Quantity

    54 units