BEUDAMED
    FDA Enforcement Class II Terminated

    MEVION S250 Product Usage: Proton Radiation Therapy

    Recall: Z-0409-2017 · Reported November 23, 2016

    Enforcement

    Recall Number
    Z-0409-2017
    Event ID
    75496
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mevion Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 23, 2016
    Initiation Date
    October 31, 2016
    Classification Date
    November 14, 2016
    Termination Date
    June 29, 2017
    Address
    300 Foster Street, N/A, Littleton, MA, 01460-2017, United States

    Description

    MEVION S250 Product Usage: Proton Radiation Therapy

    Reason

    Completing Setup Without Program Move Complete Can Cause An Isocenter Error

    Code Info

    Serial NUmbers: S250-0001 through S250-0006

    Distribution

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

    Quantity

    6 units