BEUDAMED
    FDA Enforcement Class II Terminated

    SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 11061618 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a trained physician as an aid in diagnosis. These CT systems can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

    Recall: Z-0714-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0714-2018
    Event ID
    79207
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 7, 2018
    Initiation Date
    October 2, 2017
    Classification Date
    February 23, 2018
    Termination Date
    September 27, 2018
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 11061618 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a trained physician as an aid in diagnosis. These CT systems can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

    Reason

    The table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potential to loosen and several bolts may gradually loosen at the same time.

    Code Info

    Serial Number: 106115

    Distribution

    US Nationwide Distribution in the states of FL, MO, NY, TN

    Quantity

    1