FDA-Device2016-12-28Class II
CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: 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
Accuray has become aware of a potential safety issue involving the possibility of electric shock during maintenance activities from the lon Pump HV Power Supply at the back of the modulator cabinet. This issue is limited to certain G3, G4, and VSI models of the CyberKnife¿ Robotic Radiosurgery System.
Sold states
Worldwide Distribution - US including CA. MN, OK. FL. MO, TN, KS, TX, AZ, MS, IA, MA. NC, NY. IN, NJ, VA. LA, WA, WI, PA. CT, G,. MT, MD, LA., WV, OH, and DC. Foreign distribution to Taiwan, Japan, Korea, Turkey. Malaysia, Vietnam, Greece, China, Spain, France, Italy, Pakistan, and Georgia,
Affected count
115 affected devices.
Manufactured in
1310 Chesapeake Ter, N/A, Sunnyvale, CA, United States
Products
CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: 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-0865-2017Don't want to check this manually?
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