FDA-Device2025-02-05Class II
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is 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
Snap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damaged.
Sold states
Worldwide - US Nationwide distribution.
Affected count
212
Manufactured in
1240 Deming Way, Madison, WI, United States
Products
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is 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-1023-2025Don't want to check this manually?
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