BEUDAMED
    FDA Recall Terminated

    MEVION S250 Product Usage: Proton Radiation Therapy

    Recall: Z-0409-2017 · Initiated October 31, 2016

    Recall

    Recall Number
    Z-0409-2017
    Event Number
    75496
    Firm
    Mevion Medical Systems, Inc.
    FEI Number
    3007087027
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 31, 2016
    Posted
    November 15, 2016
    Terminated
    June 29, 2017
    Address
    300 Foster Street, Littleton, MA, 01460-2017

    Description

    MEVION S250 Product Usage: Proton Radiation Therapy

    Reason

    Completing Setup Without Program Move Complete Can Cause An Isocenter Error

    Action

    Mevion issued an Important Safety Notice letter on October 31, 2016 to customers. The identified the affected product, problem, mitigation and advisory information. The letter informed customers that Mevion will release and install a software patch that removes the reliance on tracking isocenter changes for the correct reporting of the Couch position to the user displays and to the OIS. For further information mailto:[email protected]

    Distribution

    US Nationwide in the states of FL, MO, NJ and OK

    Quantity

    6 units