BEUDAMED
    FDA Recall Terminated

    Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS

    Recall: Z-0622-06 · Initiated February 3, 2006

    Recall

    Recall Number
    Z-0622-06
    Event Number
    34652
    Firm
    Fujifilm Medical System USA, Inc.
    FEI Number
    1000513161
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 3, 2006
    Posted
    March 15, 2006
    Terminated
    March 16, 2012
    Address
    419 West Ave, Stamford, CT, 06902-6300

    Description

    Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS

    Reason

    Image orientation and orientation markers may not match when an image is rotated or flipped when the CT Image is preset.

    Action

    FujiFilm Medical Systems USA notified users by letter dated 2/3/06. Users are requested to deactivate the CT Image Processing functionality SWAT (Synapse Web Administration Tool).

    Distribution

    Nationwide Foreign: Canada, Japan, Germany

    Quantity

    179 units