Device Recall XiO Radiation Treatment Planning System

  • Model / Serial
    Version 4.51 and higher
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-Domestic: AK, AL, AZ, CA, CO, CT, DC, FL, IN, IL, KY, MA, MD, MI, MN, MO, NJ, NC, ND, NY, OH, OK, PA, PR, TN, TX, VA, WA and WI; International: Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, France, Gabon, Germany, Greece, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Libya, Macedonia, Malaysia, Mali, Malta, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Suriname, Switzerland, Taiwan, Thailand, Turkey, The United Kingdom, Ukraine, Venezuela and Vietnam.
  • Product Description
    XiO Radiation Treatment Planning System. || Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Elekta, Inc., 400 Perimeter Center Ter NE Ste 50, Atlanta GA 30346-1227
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    XiO Release 4.3.0 through 4.50.00
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- (USA) nationwide Distribution, including Puerto Rico, and countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia, Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Libya, Lithuania, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Zealand, Nicaragua, 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 4.3.0 through 4.50.00. || Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
  • Manufacturer