BEUDAMED
    FDA Enforcement Class II Terminated

    MEVION S250 for Proton Radiation Therapy

    Recall: Z-1529-2016 · Reported April 27, 2016

    Enforcement

    Recall Number
    Z-1529-2016
    Event ID
    73602
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mevion Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 27, 2016
    Initiation Date
    March 15, 2016
    Classification Date
    April 20, 2016
    Termination Date
    August 24, 2017
    Address
    300 Foster Street, N/A, Littleton, MA, 01460-2017, United States

    Description

    MEVION S250 for Proton Radiation Therapy

    Reason

    Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture may fall out during Gantry motion. It is possible that it can hit a patient and cause traumatic injury or death.

    Code Info

    S250-0002

    Distribution

    US nationwide distribution to MO, OK, FL, and NJ.

    Quantity

    5