Events

Recall of Device Recall Focal 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
    57845
  • Event Risk Class
    Class 2
  • Event Number
    Z-2562-2011
  • Event Initiated Date
    2010-11-09
  • Event Date Posted
    2011-06-14
  • 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=97560
  • 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
    Focal: if a plan involving dynamic mlc delivery is sent from xio to focal and called up there in plan review, the angle of the gantry is set to zero for all beams. if this plan is then sent from focal to the r&v; system, the gantry angles all remain at zero which could lead to patient mistreatment.
  • Action
    Elekta CMS Software sent a USER NOTICE dated November 5, 2010, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. A return postcard was included for the customer to confirm receipt of the User Notice. The firm intends to correct the software so it does not modify anything about the plan sent from XiO. Customers were instructed to contact their local customer support office with any questions.

Device

Device Recall Focal Radiation Treatment Planning Workstation
  • Model / Serial
    Release 4.51.00 and higher
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Algeria, Australia, Belarus, Belgium, Brazil, Canada, Chile, China, Egypt, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Latvia, Libya, Lithuania, Mexico, Morocco, Netherlands, New Zealand, Philippines, Poland, Romania, Singapore, Slovenia, South Africa, Spain, Suriname, Switzerland, Taiwan, Turkey, Turkmenistan, and the United Kingdom.
  • Product Description
    Focal Radiation Treatment Planning Workstation. Focal Release 4.51.00 and above. || Allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data form a Windows-based PC and transfer the information back to the RTP system. It is intended for use in radiation treatment planning using generally accepted contouring methods.
  • 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