BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the Radiation Therapy Simulation system is used for simulation of treatment planning prior to the therapeutic treatment of cancer.

    Recall: Z-0235-2015 · Reported November 26, 2014

    Enforcement

    Recall Number
    Z-0235-2015
    Event ID
    69601
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 26, 2014
    Initiation Date
    October 10, 2014
    Classification Date
    November 19, 2014
    Termination Date
    June 29, 2017
    Address
    51 Valley Stream Pkwy, N/A, Malvern, PA, 19355, United States

    Description

    Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the Radiation Therapy Simulation system is used for simulation of treatment planning prior to the therapeutic treatment of cancer.

    Reason

    Siemens became aware of a very rare occurrence where an intended movement of the SimView NT simulation system components could not be stopped with usual hand control commands or by use of the collision detection functionality. It is possible that simulation system components could collide with patient and/or system equipment.

    Code Info

    Model numbers: 5496992, 5497016 with Serial numbers: 6035, 6080, 6029, 6032, 6019, 6001

    Distribution

    Worldwide Distribution - US Nationwide in the states of PA, KY, LA, MA, MI, and CA; and countries of: Argentina, Belarus, Bulgaria, Costa Rico, P.R. China, Curacao, Egypt, Repulic Korea, Germany, Greece, Hungary, Italy, Iraq, Jordan, Malaysia, Palestanian Ter, Poland, Thailand, Turkey, and Vietnam.

    Quantity

    6