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
    76090
  • Event Risk Class
    Class 2
  • Event Number
    Z-1122-2017
  • Event Initiated Date
    2016-12-16
  • Event Date Posted
    2017-02-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152138
  • 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
    An error can occur causing delta corrections to be lost when one setup field is closed and another is opened.
  • Action
    Mevion sent an Important Safety Notice to customers on 12/16/16 by email and Salesforce. The letter identified the affected product, problem and actions to be taken. Mevion provided mitigation and will release and install a software patch that removes the possibility that Deltas can be lost between multiple Setup fields. For further information contact rcessac@mevion.com.

Device

Device Recall Mevion
  • Model / Serial
    S250-0002 and S250-0003
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide in the states of OK, NJ
  • Product Description
    MEVION S250-Proton Radiation Therapy || Product Usage: || Proton Radiation Therapy
  • 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