Events

Recall of Monaco Radiation Treatment Planning System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Elekta, 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
    72424
  • Event Risk Class
    Class 2
  • Event Number
    Z-0181-2016
  • Event Initiated Date
    2015-10-16
  • Event Date Posted
    2015-10-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140993
  • 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
    Unintended update of dose and mu and incorrect assignment of bolus.
  • Action
    Elekta sent Important Field Safety Notice 382-01-MON-003 to all customers on 10/16/2015. The notice informs users of the specific product and version numbers affected by both issues. The affected devices for both issues are those running Monaco 5.10.01. Customers are instructed to complete and return acknowledgement form. Solution/fix has been released in Monaco patch 5.10.02 and all affected users will be made aware of its availability by the end of October 2015.

Device

Monaco Radiation Treatment Planning System
  • Model / Serial
    Software Version 5.10.01
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, IN, MI,MO, TX, WI, Australia, Canada, Germany,m Greece, India, Netherlands, New Zealand, Turkey and United Kingdom
  • Product Description
    Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Manufacturer Address
    Elekta, Inc., 400 Perimeter Center Ter NE Ste 50, Atlanta GA 30346-1227
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA