BEUDAMED
    FDA Recall Terminated

    SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta from either the same axial plane taken at different angles or spiral planes taken at different angles.

    Recall: Z-1350-2016 · Initiated March 22, 2016

    Recall

    Recall Number
    Z-1350-2016
    Event Number
    73639
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 22, 2016
    Posted
    April 8, 2016
    Terminated
    August 7, 2017
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta from either the same axial plane taken at different angles or spiral planes taken at different angles.

    Reason

    Siemens became aware that the front cover on some Siemens CT system was not properly welded. It is possible for the welded-in threaded bolt to break out of the ground plate of the front cover if the cover is opened during service. This could not happen during clinical operation. Therefore, there is no potential risk for the user or patient and the CT System has no risk for a malfunction during clinical operation

    Action

    Siemens sent an "Informational Only" notice to customers on 03/22/2016 informing them to be aware that the front cover on some Siemens CT systems was not properly welded. The letter was only to notify customers that the issue is being addressed with the completion of a service visit. In addition, Siemen plans to replace each cover and hand delivered each notification to customers at the time the service is performed.

    Distribution

    Distributed to: Cincinnati, OH.

    Quantity

    1 CT system