BEUDAMED
    FDA Recall 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 · Initiated May 4, 2012

    Recall

    Recall Number
    Z-2037-2012
    Event Number
    62372
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 4, 2012
    Posted
    July 19, 2012
    Terminated
    February 19, 2013
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087

    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.

    Action

    Hitachi sent a "Device Correction Notice" dated May 4, 2012 to their customers. The notice identified the affected product, problem and actions to be taken. Customers were instructed to "not use the Reconstruction Status" function to suspend active reconstructions until the software problem can be corrected. They also informed their customers that a representative will visit their facility to install the software update to permanently resolve the issue at no cost to the facility. For further information regarding this notice call 800-800-3106 x3720.

    Distribution

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

    Quantity

    Six (6) units