Device Recall XiO Radiation Treatment Planning System

Manufacturer

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

6 devices with a similar name

Learn more about the data here

  • Model / Serial
    XiO versions equal to or greater than 2.4.0 and less than 4.63.0
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including: IL, IN, MA, NJ and OK; and country of Germany.
  • Product Description
    XiO Radiation Treatment Planning System, XiO versions equal to or greater than 2.4.0 and less than 4.63.0 || The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
  • Manufacturer
  • Model / Serial
    Release 4.50 and higher
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide, Washington, DC and Puerto Rico and the countries of Albania, Algeria, Australia, Austria, Bahamas, Belarus, Belgium, Brazil, Canada, Chile, China,Croatia, Cyrus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Phillipines,Poland, Portugal, Romoania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Suriname, Switzerland, Taiwan, Thailand, Turkey, Turmenistan, Ukraine, United Kingdom, and Vietnam
  • Product Description
    XiO Radiation Treatment Planning System. XiO Release 4.50.00 and above || Used to create treatment plans for any cancer patient for who external beam radiation therapy of brachytherapy has been prescribed.
  • Manufacturer
  • Model / Serial
    XiO Release 1.5.0 and above
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including Puerto Rico, and countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Indonesia, Israel, Italy, Japan, Libya, Lithuania, Malaysia, Mexico, Morocco, .Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.
  • Product Description
    XiO Radiation Treatment Planning System, XiO Release 1.5.0 and above. || Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
  • Manufacturer
  • Model / Serial
    XiO Release 4.50.00 and above
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to medical facilities including Puerto Rico. Distribution was also made to two Military and Government consignees. Foreign distribution was made to Australia, Belgium, Brazil, Canada, Colombia, France, India, Ireland, Israel, Italy, Malaysia, Netherlands, Philippines, Poland, Spain, and United Kingdom.
  • Product Description
    XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above
  • Manufacturer
  • Model / Serial
    XiO Release 4.0.2 and above
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (Nationwide distribution, including Washington, DC and Puerto Rico) and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Mongolia, Morocco, Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.
  • Product Description
    XiO Radiation Treatment Planning System, XiO Release 4.0.2 and above || Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
  • Manufacturer
One more