Events

Recall of Device Recall 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 Computerized 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
    58258
  • Event Risk Class
    Class 2
  • Event Number
    Z-2564-2011
  • Event Initiated Date
    2010-05-31
  • Event Date Posted
    2011-06-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98825
  • 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
    Monaco: due to a software defect, the radiological depth (cm) and ssd to drp (cm) parameters are reported incorrectly on the beam summary report. this occurs for all monaco imrt plans.
  • Action
    Computerized Medical System sent a "USER NOTICE" letter dated June 24, 2010, to all affected users. This notice identified the product, the problem, and the actions to be taken. There is no current workaround. All customers will be mailed a postcard to be returned as proof of receipt and understanding of the notification. Consignees will be contact via telephone or e-mail after June 30, 2010 if the postcard is not returned This notice is to be distributed to any and all users of CMS software at your organization who are potentially affected. The notice states the issue will be resolved in Monaco Release 2.04, but no date for this release was given. For further questions, please call (403) 830-8023

Device

Device Recall Monaco Radiation Treatment Planning System
  • Model / Serial
    Monaco Release 2.0.1 and above
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and the countries of Australia, Austria, Belgium, China, Finland, France, Germany, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, Switzerland, Taiwan, Thailand and United Kingdom.
  • Product Description
    Monaco Radiation Treatment Planning System, Monaco Release 2.0.1 and above || Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed.
  • Manufacturer
    Computerized Medical Systems Inc

Manufacturer

Computerized Medical Systems Inc
  • Manufacturer Address
    Computerized Medical Systems Inc, 13723 Riverport Drive, Suite 100, Maryland Heights MO 63043
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA