Products: neuro-robot, orthopedic-robot. Risk band: Low RobotRisk index 4.0/100 (incidents/exposure, time-weighted) · 86th percentile of 162 medical robotics companies.
The register carries a single entry for Brainlab: a 2016 FDA Class II recall of the ExacTrac Vero patient positioning system used in radiation therapy, logged at severity 3. This is a regulator-driven record, not a press-driven one, and reflects a single isolated event rather than a repeating pattern. With an index of 4 and a percentile of 86.3, Brainlab sits in the low band relative to other medical-robotics entities, indicating a comparatively thin record within its category. The dataset provides no basis to characterize trajectory beyond this one decade-old entry.
| Sev | Date | Type | Location | Incident | Source |
|---|---|---|---|---|---|
| S3 | 05/04 2016 |
recall | — | FDA Class II recall: ExacTrac Vero is a Patient Positioning System for Radiation therapy. · ExacTrac Vero is a Patient Positioning… | openFDA enforcement |