BEUDAMED
    FDA Enforcement Class II Terminated

    MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy

    Recall: Z-1271-2014 · Reported April 2, 2014

    Enforcement

    Recall Number
    Z-1271-2014
    Event ID
    67657
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mevion Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    April 2, 2014
    Initiation Date
    March 5, 2014
    Classification Date
    March 21, 2014
    Termination Date
    April 3, 2014
    Address
    300 Foster St, N/A, Littleton, MA, 01460-2017, United States

    Description

    MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy

    Reason

    Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields

    Code Info

    S250-0001

    Distribution

    USA Nationwide Distribution in the state of MO

    Quantity

    1 unit