BEUDAMED
    FDA Enforcement Class II Terminated

    SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.

    Recall: Z-0971-2015 · Reported January 21, 2015

    Enforcement

    Recall Number
    Z-0971-2015
    Event ID
    69957
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 21, 2015
    Initiation Date
    December 3, 2014
    Classification Date
    January 14, 2015
    Termination Date
    April 6, 2015
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406, United States

    Description

    SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.

    Reason

    Artifacts are found in acquired imaging on the SOMATOM Force.

    Code Info

    Model number: 10742326, serial numbers 75437, 75454, 75464, 75450, 75467, 75475, 75439.

    Distribution

    PA, MA, MN, SC, MD, and TX.

    Quantity

    7