Products: neuro-robot, surgical-robot. Risk band: Elevated RobotRisk index 23.1/100 (incidents/exposure, time-weighted) · 95th percentile of 162 medical robotics companies.
The record shows two FDA Class II recalls tied to the EPIONE stereotactic accessory system, one in August 2024 and one in May 2025, both severity 3. Two recalls on the same device family across roughly nine months indicate a recurring corrective-action pattern rather than an isolated defect. Both entries are regulator-driven, consistent with FDA device-safety oversight of the medical-robotics category. Index 23.3 and the 95th percentile place Quantum Surgical in the elevated band, reflecting this repeat-recall trajectory.
| Sev | Date | Type | Location | Incident | Source |
|---|---|---|---|---|---|
| S3 | 05/23 2025 |
recall | — | FDA Class II recall: EPIONE Model 30-0001 · EPIONE Model 30-0001 | openFDA enforcement |
| S3 | 08/05 2024 |
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 con… | openFDA enforcement |