BEUDAMED
    FDA Enforcement Class II Terminated

    SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

    Recall: Z-1458-2018 · Reported May 9, 2018

    Enforcement

    Recall Number
    Z-1458-2018
    Event ID
    79428
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 9, 2018
    Initiation Date
    February 15, 2018
    Classification Date
    April 30, 2018
    Termination Date
    April 8, 2020
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

    Reason

    to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure

    Code Info

    8874427

    Distribution

    USA (nationally) Distribution.

    Quantity

    1301