FDA-Device2021-03-24Class II
CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Accuray Incorporated
Hazard
The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.
Sold states
Worldwide distribution - US Nationwide distribution including in the states of AK, AZ. CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI, WV, PR and the countries of Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Republic of Korea, Latvia, Luxembourg, Malaysia, Mexico, Oman, Pakistan, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.
Affected count
243 units
Manufactured in
1240 Deming Way, N/A, Madison, WI, United States
Products
CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1272-2021Don't want to check this manually?
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