Events

Recall of Device Recall MEVION

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mevion Medical Systems, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69778
  • Event Risk Class
    Class 2
  • Event Number
    Z-0588-2015
  • Event Initiated Date
    2014-11-10
  • Event Date Posted
    2014-12-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131530
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, radiation therapy, charged-particle, medical - Product Code LHN
  • Reason
    Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. this could result in an incorrect dose delivery of no more than 5%.
  • Action
    Mevion Medical Systems sent an Important Safety Notice letter to the affected customer. The letter identified the affected product, problem and actions to be taken. A software update addressing the issue will be provided to the customer on or about December 5, 2014. For questions or concerns, email lbouchet@mevion.com or call 978-540-1555.

Device

Device Recall MEVION
  • Model / Serial
    Serial Number: S250-0001
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution in the state of MO
  • Product Description
    MEVION S250, used for proton radiation therapy.
  • Manufacturer
    Mevion Medical Systems, Inc.

Manufacturer

Mevion Medical Systems, Inc.
  • Manufacturer Address
    Mevion Medical Systems, Inc., 300 Foster St, Littleton MA 01460-2017
  • Manufacturer Parent Company (2017)
    Mevion Medical Systems, Inc.
  • Source
    USFDA