FDA-Device2014-03-12Class II
Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
Elekta, Inc.
Hazard
During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
Sold states
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AK, AZ, CA, CT, FL, GA, IL, KY, LA, MD, MA, MI, MO, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SD, TN, TX, VT, VA, WA, WV, WI, and WY, and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Cuba, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan , Panama, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Vietnam.
Affected count
134
Manufactured in
400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, United States
Products
Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1085-2014Don't want to check this manually?
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