BEUDAMED
    FDA Enforcement Class II Terminated

    SOMATOM Emotion 6; 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-1934-2015 · Reported July 8, 2015

    Enforcement

    Recall Number
    Z-1934-2015
    Event ID
    71484
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 8, 2015
    Initiation Date
    June 4, 2015
    Classification Date
    June 27, 2015
    Termination Date
    March 24, 2017
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406, United States

    Description

    SOMATOM Emotion 6; 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

    A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.

    Code Info

    model numbers: 10165888 with serial numbers: 29161 29185 29186 29165 29176 29181 29198

    Distribution

    Nationwide Distribution.

    Quantity

    40 total