BEUDAMED
    FDA Enforcement Class II Terminated

    MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation

    Recall: Z-0485-2021 · Reported December 2, 2020

    Enforcement

    Recall Number
    Z-0485-2021
    Event ID
    86693
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mevion Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 2, 2020
    Initiation Date
    October 19, 2020
    Classification Date
    November 24, 2020
    Termination Date
    August 31, 2021
    Address
    300 Foster St, N/A, Littleton, MA, 01460-2017, United States

    Description

    MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation

    Reason

    Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur

    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

    Worldwide distribution - US Nationwide distribution including in the states of DC, FL, MO, NJ, OK and the country of Netherlands.

    Quantity

    8 units