Products: surgical-robot, neuro-robot. Risk band: Low RobotRisk index 12.6/100 (incidents/exposure, time-weighted) · 91th percentile of 162 medical robotics companies.
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 index of 12.8 and 90.7 percentile place Accuray in the low band despite the multi-event history, indicating the recurrence is registered but not severe relative to category peers. The record is regulator-driven, consisting entirely of FDA recall classifications spanning an eight-year interval rather than a clustered or press-originated pattern.
| Sev | Date | Type | Location | Incident | Source |
|---|---|---|---|---|---|
| S3 | 02/26 2021 |
recall | — | FDA Class II recall: CyberKnife Treatment Delivery System - Product Usage: indicated for im · CyberKnife Treatment Delivery System -… | openFDA enforcement |
| S3 | 12/06 2016 |
recall | — | FDA Class II recall: CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. · CyberKnife Robotic Radiosurgery System… | openFDA enforcement |
| S3 | 03/27 2013 |
recall | — | FDA Class II recall: RoboCouch Patient Positioning System · RoboCouch Patient Positioning System | openFDA enforcement |