BEUDAMED
    FDA Enforcement Class II Terminated

    Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the Scenaria can be post processed by the Scenaria to provide additional information. Post processing capabilities included in the Scenaria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.

    Recall: Z-2037-2012 · Reported July 25, 2012

    Enforcement

    Recall Number
    Z-2037-2012
    Event ID
    62372
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hitachi Medical Systems America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 25, 2012
    Initiation Date
    May 4, 2012
    Classification Date
    July 19, 2012
    Termination Date
    February 19, 2013
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087, United States

    Description

    Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the Scenaria can be post processed by the Scenaria to provide additional information. Post processing capabilities included in the Scenaria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.

    Reason

    Hitachi discovered a software error in the Reconstruction Status function that creates a potential risk that a patient study will not be fully reconstructed. When multiple reconstructions are queued for processing, if a queue is suspended and the task order changed, the second queue may not reconstruct the full range of slices. This may result in missing diagnostic data.

    Code Info

    Serial #'s S5001 - S5011

    Distribution

    US Nationwide Distribution to the following states of: MD, MI, MX, ND, NY, OH and TX.

    Quantity

    Six (6) units