Device Recall FOCAL Workstation

  • Model / Serial
    Focal Release 4.40.00 and above
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including states of: CA, CO, FL, IL, IN, KS, MO, NC, OH, OK, PA, TN, and WA. and countries of Australia, Austria, Canada, India, Netherlands, Portugal, Singapore, Spain, and United Kingdom.
  • Product Description
    Focal Radiation Treatment Planning System, Focal Release 4.40.00 and above. || Product Usage: for use in radiation treatment planning using generally accepted contouring methods. The Focal software 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 from a Windows-based PC and transfer the information back to the RTP system.
  • Manufacturer
  • 1 Event

Manufacturer

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

One device with a similar name

Learn more about the data here

  • Model / Serial
    Focal Release 4.1.1 through 4.40.00
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including the state of: Puerto Rico and countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Mongolia, Morocco, Netherlands, New Zealand, Nicaragua, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sudan, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, United Kingdom, Uruguay and Venezuela.
  • Product Description
    Focal Radiation Treatment Planning System, Focal Release 4.1.1 through 4.40.00. || Product Usage: for use in radiation treatment planning using generally accepted contouring methods. The Focal software 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 from a Windows-based PC and transfer the information back to the RTP system.
  • Manufacturer