Events

Recall of Device Recall 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
    72210
  • Event Risk Class
    Class 2
  • Event Number
    Z-0767-2016
  • Event Initiated Date
    2015-11-18
  • Event Date Posted
    2016-02-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140206
  • 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
    The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment.
  • Action
    Customer notification letter was sent via certified mail on November 18, 2015. The notification explains the issue and actions to be taken by the customer.

Device

Device Recall MEVION S250
  • Model / Serial
    Manufacturing Lot or Serial Number: S250-0004
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US nationwide distribution including FL, NJ, OK, and MO.
  • Product Description
    MEVION S250 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