BEUDAMED
    FDA Enforcement Class II Terminated

    MEVION S250 Product Usage: Proton Radiation Therapy System

    Recall: Z-0411-2017 · Reported November 23, 2016

    Enforcement

    Recall Number
    Z-0411-2017
    Event ID
    75494
    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 20, 2016
    Classification Date
    November 14, 2016
    Termination Date
    May 15, 2017
    Address
    300 Foster Street, N/A, Littleton, MA, 01460-2017, United States

    Description

    MEVION S250 Product Usage: Proton Radiation Therapy System

    Reason

    Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter

    Code Info

    Serial Numbers: S250-0001 through S250-0006

    Distribution

    US Nationwide Distribution in the states of: FL, MO, NJ, OH, OK

    Quantity

    6 units