BEUDAMED
    FDA Recall 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 · Initiated June 4, 2015

    Recall

    Recall Number
    Z-1934-2015
    Event Number
    71484
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 4, 2015
    Posted
    June 27, 2015
    Terminated
    March 24, 2017
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    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.

    Action

    A safety advisory notice, dated June 4, 2015, was sent to direct accounts explaining the problem and potential risk to patients and operators. Siemens engineers will begin replacing the bolts in May 2015.

    Distribution

    Nationwide Distribution.

    Quantity

    40 total