Events

Recall of MEVION S250

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
    75494
  • Event Risk Class
    Class 2
  • Event Number
    Z-0411-2017
  • Event Initiated Date
    2016-10-20
  • Event Date Posted
    2016-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150503
  • 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,planning,radiation therapy treatment - Product Code MUJ
  • Reason
    Software defect:2d projection of contours in verity. the defect causes structures to appear off from their true position in the drr and the radiograph with an error that increases with the distance of the structure from isocenter.
  • Action
    Mevion issued an Important Safety Notice letter on October 14, 2016 to their customers. The letter identified the affected product, problem, containment, mitigation and actions taken. Customers were informed that Mevion will be updating software when it is released. For further Information, contact: srosenthal@mevion.com.

Device

MEVION S250
  • Model / Serial
    Serial Numbers: S250-0001 through S250-0006
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of: FL, MO, NJ, OH, OK
  • Product Description
    MEVION S250 || Product Usage: Proton Radiation Therapy System
  • Manufacturer
    Mevion Medical Systems, Inc.

Manufacturer

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