BEUDAMED
    FDA Recall Terminated

    MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy

    Recall: Z-1271-2014 · Initiated March 5, 2014

    Recall

    Recall Number
    Z-1271-2014
    Event Number
    67657
    Firm
    Mevion Medical Systems, Inc.
    FEI Number
    3007087027
    Product Code
    LHN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 5, 2014
    Posted
    March 22, 2014
    Terminated
    April 3, 2014
    Address
    300 Foster St, Littleton, MA, 01460-2017

    Description

    MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy

    Reason

    Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields

    Action

    Mervion issued an Important Safety Notice letter on March 5, 2014 by visit to sites to the single customer using the product to prevent the use of multiple isocenters treatment modalities. The letter identified the affected product, problem and actions to be taken. For questions call 978-540-1555.

    Distribution

    USA Nationwide Distribution in the state of MO

    Quantity

    1 unit