BEUDAMED
    FDA Recall Terminated

    MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients

    Recall: Z-2686-2020 · Initiated June 23, 2020

    Recall

    Recall Number
    Z-2686-2020
    Event Number
    86028
    Firm
    Mevion Medical Systems, Inc.
    FEI Number
    3007087027
    Product Code
    LHO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 23, 2020
    Terminated
    December 9, 2020
    Address
    300 Foster St, Littleton, MA, 01460-2017

    Description

    MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients

    Reason

    The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer.

    Action

    This screen would not be accessed by normal user (only servicer). Firm is notifying servicing personnel and not consumer/user level. No customer letters/communication sent. Servicer will install edge guard on effected units. Technical Service Bulletin issued to servicer.

    Distribution

    MO, NJ, OK, FL, OH, DC, Netherlands

    Quantity

    8 units