FDA-Device2014-03-12Class II
Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
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
455
Manufactured in
400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, United States
Products
Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1083-2014Don't want to check this manually?
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