BEUDAMED
    FDA Recall Terminated

    ARTISTE and ONCOR linear accelerators with G31 mother board. ARTISTE and ONCOR are manufactured by Siemens Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany. ARTISTE, ONCOR and PRIMUS family of linear accelerators deliver X-ray photon and electron radiation for therapeutic treatment of cancer.

    Recall: Z-0459-2012 · Initiated November 9, 2011

    Recall

    Recall Number
    Z-0459-2012
    Event Number
    60525
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2937457
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    November 9, 2011
    Posted
    January 11, 2012
    Terminated
    April 15, 2013
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200

    Description

    ARTISTE and ONCOR linear accelerators with G31 mother board. ARTISTE and ONCOR are manufactured by Siemens Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany. ARTISTE, ONCOR and PRIMUS family of linear accelerators deliver X-ray photon and electron radiation for therapeutic treatment of cancer.

    Reason

    Reports of gantry rotation without receiving a movement command caused by an overload within the drive signal power line.

    Action

    Siemens Medical Solutions USA, Inc. sent a Customer Information letter dated November 9, 2011, by federal express. The letter identified the product the problem and the action needed to be taken by the customer. The HW Update included information regarding the potential problem and provide instructions in the Safety update. Further questions call (925) 602-8157.

    Distribution

    Worldwide Distribution-- USA ( nationwide ) including the states of : MO, NC, OH, and OK and the countries of Turkey, Japan, Germany and Portugal

    Quantity

    13 active devices