BEUDAMED
    FDA Recall Terminated

    ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x AND an ARTISTE Linear Accelerator/RT Therapist v4.1 system with the LANTIS OIS. The Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    Recall: Z-2789-2011 · Initiated May 25, 2011

    Recall

    Recall Number
    Z-2789-2011
    Event Number
    59055
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2937457
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 25, 2011
    Posted
    July 11, 2011
    Terminated
    March 1, 2012
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200

    Description

    ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x AND an ARTISTE Linear Accelerator/RT Therapist v4.1 system with the LANTIS OIS. The Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    Reason

    Potential safety issue of possible data loss for the transfer of the same patients treatment data between the LANTIS OIS and the RTT v2.x software and the RT Therapist version 4.1 system

    Action

    Siemens Customers Service group began providing Update Instructions and installing the software update on affected machines beginning May 25, 2011. A customer information letter was also provided.

    Distribution

    Worldwide Distribution - USA including distribution to LA, CA, PA, MA, NE, NJ, DE, WI, NC, NY, WI, MD, FL, KY and to Poland, Netherlands, Ireland, G=Belgium, Germany, New Zealand, P.R. China, Saudi Arabia, Australia, Malaysia, Egypt, Canada, and Spain.

    Quantity

    45 customers with affected configuration in US, 37 customers ROW.