BEUDAMED
    FDA Enforcement Class II Terminated

    MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy

    Recall: Z-1122-2017 · Reported February 8, 2017

    Enforcement

    Recall Number
    Z-1122-2017
    Event ID
    76090
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mevion Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 8, 2017
    Initiation Date
    December 16, 2016
    Classification Date
    February 2, 2017
    Termination Date
    April 13, 2017
    Address
    300 Foster Street, N/A, Littleton, MA, 01460-2017, United States

    Description

    MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy

    Reason

    An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened

    Code Info

    S250-0002 and S250-0003

    Distribution

    US Nationwide in the states of OK, NJ

    Quantity

    2 units