BEUDAMED
    FDA Recall Terminated

    Hitachi Emission Computed Tomography System Hitachi CX-4 CT (including SceptreP3 PET-CT)

    Recall: Z-1079-06 · Initiated February 21, 2006

    Recall

    Recall Number
    Z-1079-06
    Event Number
    35086
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 21, 2006
    Posted
    June 3, 2006
    Terminated
    November 13, 2008
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087-2371

    Description

    Hitachi Emission Computed Tomography System Hitachi CX-4 CT (including SceptreP3 PET-CT)

    Reason

    The device has a software anomaly which causes blank images to be created during Multiplanar Reconstruction processing or results in an inherent filming error in which a reference scale is improperly sized.

    Action

    Hitachi Medical Systems America, Inc. was informed of a software-related problem with the 50mm scale displayed on filmed images. This problem was reported to the firm by their Japanese manufacturer. In cases where the image has been magnified before filming, the 50mm scale is not correctly sized to the magnified image. The firm issued a Device Correctioin Notice to their customers on 2/21/2006. The notice concerns the referenced software problem which results in the resizing of the images, as well as a second previously discovered problem which results in blank multi-planer reconstructions (MPR''s). According to the Device Correction Notice, a software upgrade has already been installed on all of the units in order to correct the MPRs problem [Ref: RES #35081, Correction Removal Report #1528028-01/31/06-003-C] In response to the resizing issue, a second software upgrade [which the firm states address both issues] will be released on or before 2/27/2006, and this software upgrade will be performed by HMSA''s service personnel during each customer''s next scheduled PM. The Device Notification Letter also instructs the customers to call their Field Service Representatives or the HMSA Applications Helpline if they have any questions about the notice, or if any additional problems are encountered.

    Distribution

    The 16 devices were distributed to 11 states: Texas, Florida, Louisiana, Illinois, Connecticut, Ohio, Massachusetts, Wisconsin, Idaho, California, New Jersey

    Quantity

    16