RobotRisk Autonomous Systems Incident & Risk Register
RobotRisk › Robot types › Neurosurgical / ablation robot
Robot type · Medical & surgical robots · industry Medical robotics

Neurosurgical / ablation robot

Type index 25.3/100 · 11 incidents (3 at S4+) · 5 of 15 tracked companies have incidents of this type · 5 tracked products.

Companies ranked within Neurosurgical / ablation robot

CompanyShare of company riskRankCompany index
Quantum Surgical100%1 of 538.1
Neuralink100%2 of 535.0
Monteris Medical100%3 of 524.1
Accuray89%4 of 520.8
Brainlab100%5 of 56.5

Products

ProductCompanyRobot typeStatusIncidentsIndex
EpioneQuantum Surgical Neurosurgical / ablation robotshipping238.1
N1 implant / R1 surgical robotNeuralink Neurosurgical / ablation robotresearch235.0
NeuroBlateMonteris Medical Neurosurgical / ablation robotshipping424.1
CyberKnifeAccuray Neurosurgical / ablation robotshipping219.3
CirqBrainlab Neurosurgical / ablation robotshipping16.5

Incidents

11 of 11 incidents
SevDateCompanyTypeLocationIncidentSource
S323 May 2025Quantum Surgical recall —FDA Class II recall: EPIONE Model 30-0001 · EPIONE Model 30-0001 openFDA enforcement
S305 Aug 2024Quantum Surgical recall —FDA Class II recall: The EPIONE device v1.0.2 is a user controlled, stereotactic accessory · The EPIONE device v1.0.2 is a user controlled, stereotactic openFDA enforcement
S308 May 2024Neuralink malfunction —Neuralink brain implant threads retract in first human patient CBS News
S4~2022Neuralink fatality —Federal inquiry into Neuralink over animal deaths in implant testing The Guardian
S326 Feb 2021Accuray recall —FDA Class II recall: CyberKnife Treatment Delivery System - Product Usage: indicated for im · CyberKnife Treatment Delivery System - Product Usage: indica openFDA enforcement
S304 Jan 2019Monteris Medical recall —Monteris Medical had a serious recall Medical Design & Outsour
S4~Oct 2017Monteris Medical recall —FDA Class I recall: MONTERIS MEDICAL NEUROBLATE SYSTEM, used for · MONTERIS MEDICAL NEUROBLATE SYSTEM, used for openFDA enforcement
S306 Dec 2016Accuray recall —FDA Class II recall: CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. · CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI openFDA enforcement
S304 May 2016Brainlab recall —FDA Class II recall: ExacTrac Vero is a Patient Positioning System for Radiation therapy. · ExacTrac Vero is a Patient Positioning System for Radiation openFDA enforcement
S425 Mar 2016Monteris Medical recall —FDA Class I recall: NeuroBlate System SideFire Select · NeuroBlate System SideFire Select openFDA enforcement
S303 Oct 2014Monteris Medical recall —FDA Class II recall: FullFire Diffusing Tip Laser Probe, REF: · FullFire Diffusing Tip Laser Probe, REF: openFDA enforcement

Tracked companies shipping Neurosurgical / ablation robot

AccurayAxilum RoboticsBionaut LabsBrainlabClearPoint NeuroGlobus MedicalInterventional SystemsMonteris MedicalNeuralinkPerfint HealthcareQuantum SurgicalRenishawRobeauteSynaptive MedicalXCath
Also from Critical Systems Analysis: CSA - functional safety engineering · Company directory · FSTalent - functional safety jobs