Quantum Surgical
Robot types: Neurosurgical / ablation robot, Surgical robot. Risk band: Elevated RobotRisk index 38.1/100 (severity- and time-weighted incidents) · ranked 5 of 25 among Medical robotics companies with incidents (274 tracked).
Analyst brief
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.
Risk index
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 | 100% | 1 of 5 |
| Product | Robot type | Status | Incidents | Index |
|---|---|---|---|---|
| Epione | Neurosurgical / ablation robot | shipping | 2 | 38.1 |
Incident timeline
Comparisons over time
Per-type breakdown
| Incident type | Unique incidents | Share |
|---|---|---|
| recall | 2 | 100% |
Unique incident list
2 unique incidents on file for this company.
| Sev | Date | Type | Location | Incident | Source |
|---|---|---|---|---|---|
| S3 | 23 May 2025 | recall | — | FDA Class II recall: EPIONE Model 30-0001 · EPIONE Model 30-0001 | openFDA enforcement |
| S3 | 05 Aug 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 controlled, stereotactic | openFDA enforcement |
S3 23 May 2025 · recall · FDA Class II recall: EPIONE Model 30-0001
| Sev | Date | Supporting source row | Source |
|---|---|---|---|
| S3 | 23 May 2025 | FDA Class II recall: EPIONE Model 30-0001 | openFDA enforcement |
S3 05 Aug 2024 · recall · FDA Class II recall: The EPIONE device v1.0.2 is a user controlled, stereotactic accessory
| Sev | Date | Supporting source row | Source |
|---|---|---|---|
| S3 | 05 Aug 2024 | FDA Class II recall: The EPIONE device v1.0.2 is a user controlled, stereotactic accessory | openFDA enforcement |
Similar companies
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