BEUDAMED
    FDA Enforcement Class II Terminated

    SOMATOM Emotion 16; 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-1933-2015 · Reported July 8, 2015

    Enforcement

    Recall Number
    Z-1933-2015
    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 16; 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: 10165977, with serial numbers: 32310 32254 32322 32317 32303 32295 32327 32309 32319 32237 32326 32259 32323 32257 32298 32315 32268 32244 32252 32293 32349 32313 32334 32301 32339 32277 32292 32281 32273 32320 32324 32346 32270

    Distribution

    Nationwide Distribution.

    Quantity

    40 total