Accuray

Products: surgical-robot, neuro-robot. Risk band: Elevated RobotRisk index 21.0/100 (severity- and time-weighted incidents) · ranked 16 of 25 among Medical robotics companies with incidents (173 tracked).

Analyst brief

Accuray's record in the medical-robotics category spans three FDA Class II recalls from 2013 to 2021, covering the RoboCouch Patient Positioning System, the CyberKnife Robotic Radiosurgery System (models G3, G4, VSI), and the CyberKnife Treatment Delivery System. All three entries carry a uniform severity rating of 3, and all are classified identically as recalls, showing a consistent failure mode centered on device-level product corrections rather than escalating severity over time. Accuray's index of 21.1 ranks 16 of 25 companies in Medical robotics with incident history. The record is regulator-driven, consisting entirely of FDA recall classifications spanning an eight-year interval rather than a clustered or press-originated pattern.

Risk index

21.0/100RobotRisk index

22.1/100Median index across the 25 Medical robotics companies with incident history (173 tracked, 148 with none)

16 of 25Rank in Medical robotics (of 25 with incident history)

ElevatedRisk band

Incident timeline

Comparisons over time

Per-type breakdown

Incident type	Unique incidents	Share
recall	3	100%

Unique incident list

3 unique incidents on file for this company.

Sev	Date	Type	Location	Incident	Source
S3	26 Feb 2021	recall	—	FDA Class II recall: CyberKnife Treatment Delivery System - Product Usage: indicated for im · CyberKnife Treatment Delivery System - Product Usage: indica	openFDA enforcement
S3	06 Dec 2016	recall	—	FDA Class II recall: CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. · CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI	openFDA enforcement
S3	27 Mar 2013	recall	—	FDA Class II recall: RoboCouch Patient Positioning System · RoboCouch Patient Positioning System	openFDA enforcement