Events

Recall of Device Recall 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
    57801
  • Event Risk Class
    Class 2
  • Event Number
    Z-2598-2011
  • Event Initiated Date
    2011-01-13
  • Event Date Posted
    2011-06-20
  • 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=97474
  • 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: when the isocenter location is edited in the imrt activity screen, the shift coordinates are not updated in the imrt plan report.
  • Action
    Computerized Medical Systems Inc drafted a User Notice which explains the reason for correction, the clinical impact, and the workaround method. The User Notice was sent January 13, 2011. A return postcard is 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

Device Recall Monaco Radiation Treatment Planning Workstation
  • Model / Serial
    Monaco Release 2.03.00and above
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (Nationwide distribution to AK, AZ, CA, CO, FL, IL, IN, MA, MI, MN, MO, NC, NM, NY, OH, OR, PA, SC, TX, VA, WA, and WI and the countries of Algeria, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Phillipines, Poland, Portugal, Singapore, Slovenia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and the United Kindom.
  • Product Description
    Monaco Radiation Treatment Planning Workstation, Monaco Release 2.03.00 and above || To create treatment plans for any cancer patient for whom 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