Events

Recall of Monaco Radiation Treatment Planning Workstation

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
    57843
  • Event Risk Class
    Class 2
  • Event Number
    Z-2569-2011
  • Event Initiated Date
    2010-10-27
  • Event Date Posted
    2011-06-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97545
  • 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: in xio imrt (dynamic mlc delivery) software, the radiation beam angle is set to zero. if different beam angles are selected via monaco software, the beam angles will remain at zero.
  • Action
    Computerized Medical Systems, Inc. sent a User Notice to the affected consignees on October 27, 2010, explaining the reason for correction, the clinical impact, and the workaround method. (VERIFY USE NOTICE DATE) A return postcard was included for the customer to confirm receipt of the User Notice. The firm intends for this issue to be corrected in Monaco Release 3.00 in March 2011.

Device

Monaco Radiation Treatment Planning Workstation
  • Model / Serial
    Release 2.04 and higher
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, IL, MN, NM, OH, NY, TX, and WA and the Netherlands.
  • Product Description
    Monaco Radiation Treatment Planning Workstation. Monaco Release 2.04.00 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