BEUDAMED
    FDA Enforcement Class II Terminated

    MEVION S250i, MEVION S250; Proton Radiation Treatment System

    Recall: Z-2406-2020 · Reported July 1, 2020

    Enforcement

    Recall Number
    Z-2406-2020
    Event ID
    85748
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mevion Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 1, 2020
    Initiation Date
    May 15, 2020
    Classification Date
    June 22, 2020
    Termination Date
    December 11, 2020
    Address
    300 Foster St, N/A, Littleton, MA, 01460-2017, United States

    Description

    MEVION S250i, MEVION S250; Proton Radiation Treatment System

    Reason

    Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off

    Code Info

    Serial Numbers: MEVION S250-0001 MEVION S250-0002 MEVION S250-0003 MEVION S250-0004 MEVION S250-0005 MEVION S250-0006 MEVION S250-0007 MEVION S250-0008 UDI: (01)00864366000100 (11) 131209 (01)00864366000100 (11)150526 (01)00864366000100 (11)150113 (01)00864366000100 (11)150430 (01)00864366000100 (11)160127 (01)00864366000100 (11)160603 (01)00864366000124 (11) 180220 (01)00864366000124 (11) 181219

    Distribution

    Distribution to US in MO, NJ, OH, OK, FL, and DC, and the Netherlands

    Quantity

    8 units