FDA-Device2016-02-17Class II
CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and 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 gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come into contact with a patient.
Sold states
Worldwide Distribution. US Nationwide, Venezuela, United Kingdom, Ukraine, Turkey, Thailand, Taiwan, Switzerland, Spain, Saudi Arabia, Russia, Poland, Pakistan, Myanmar, Mexico, Korea, Japan, Italy, Ireland, India, Greece, Germany, France, Finland, Czech Republic, Colombia, China, Canada, and Belgium.
Affected count
226
Manufactured in
1310 Chesapeake Ter, N/A, Sunnyvale, CA, United States
Products
CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and 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-0771-2016Don't want to check this manually?
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