Events

Recall of Monaco RTP System Radiation Therapy 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
    65998
  • Event Risk Class
    Class 2
  • Event Number
    Z-2277-2013
  • Event Initiated Date
    2013-05-22
  • Event Date Posted
    2013-09-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121168
  • 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
    Patient needs to be positioned as indicated by the treatment plan.
  • Action
    Computerized Medical Systems issued an Important Safety Notice dated May 22, 2013 to all affected customers. This letter idenitfies the problems the products and the actions needed to be takem by the custom.

Device

Monaco RTP System Radiation Therapy Treatment Planning System.
  • Model / Serial
    All versions of Monaco
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in Puerto Rico and the states of AK, AZ, CA, CO, CT, FL, IL, IN, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, and WA.
  • Product Description
    Monaco RTP System Radiation Therapy Treatment Planning 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