Events

Recall of Device Recall Monaco RTP 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
    64328
  • Event Risk Class
    Class 2
  • Event Number
    Z-0841-2013
  • Event Initiated Date
    2013-02-11
  • Event Date Posted
    2013-02-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115838
  • 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
    The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.
  • Action
    Elekta provided customers with an "Important Safety Notice - Dose Display Not Matching Beam Geometry - Monaco RFC 35748". The notice identified the product, problem, and actions to be taken by the customers. Contact the form at 800-878-4267 for questions relating to this notice.

Device

Device Recall Monaco RTP System
  • Model / Serial
    Versions 3.20.00 and 3.20.01
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI.
  • Product Description
    Monaco RTP System. || Radiation treatment planning.
  • 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