Accuray

Robot types: Surgical robot, Neurosurgical / ablation robot. Risk band: Elevated RobotRisk index 20.8/100 (severity- and time-weighted incidents) · ranked 16 of 25 among Medical robotics companies with incidents (274 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. 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

20.8/100RobotRisk index

21.8/100Median index across the 25 Medical robotics companies with incident history (274 tracked, 249 with none)

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

ElevatedRisk band

Products and robot types

Industries: Medical robotics · Sectors: Hospitals and Health Care

Risk is scored per product and robot type: each incident is attributed to the product it names, or to the company's matching robot type.

Robot type	Share of company risk	Rank within type
Neurosurgical / ablation robot	89%	4 of 5
Surgical robot	11%	8 of 8

Product	Robot type	Status	Incidents	Index
CyberKnife	Neurosurgical / ablation robot	shipping	2	19.3
TomoTherapy / Radixact	Surgical robot	shipping	0	0.0

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