BEUDAMED
    FDA Recall Terminated

    MEVION S250 Product Usage: Proton Radiation Therapy System

    Recall: Z-0410-2017 · Initiated October 21, 2016

    Recall

    Recall Number
    Z-0410-2017
    Event Number
    75498
    Firm
    Mevion Medical Systems, Inc.
    FEI Number
    3007087027
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    October 21, 2016
    Posted
    November 15, 2016
    Terminated
    May 10, 2017
    Address
    300 Foster Street, Littleton, MA, 01460-2017

    Description

    MEVION S250 Product Usage: Proton Radiation Therapy System

    Reason

    Recovery of Incorrect Isocenter -operational change

    Action

    Mevion issued an User Notice letter on October 24, 2016 to their customers. The letter identified the affected product, problem and actions taken. Customers were informed that Mevion will be updating software when it is released. For further clarification or assistance, please contact Rob Cessac by email at [email protected] or by phone at (978) 540-1501.

    Distribution

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

    Quantity

    6 units