Products: rehab-exoskeleton. Risk band: Low RobotRisk index 8.7/100 (incidents/exposure, time-weighted) · 89th percentile of 162 medical robotics companies.
Hocoma's record in the medical-robotics category holds two entries: a 2015 report of a proximal tibia fracture in a spinal-cord-injury patient associated with robotic rehabilitation, and a 2020 FDA Class II recall of the Lokomat Pro system. The two events differ in type and severity, an injury rated 2 and a recall rated 3, showing a pattern that spans both a documented adverse event and a subsequent regulatory correction on the same product line. The index of 8.8 and 89.4 percentile place Hocoma in the low band across this five-year span. The record combines an injury report with a regulator-driven recall, rather than resting on a single source type.
| Sev | Date | Type | Location | Incident | Source |
|---|---|---|---|---|---|
| S3 | 06/08 2020 |
recall | — | FDA Class II recall: Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD · Lokomat Pro, Catalog Numbers 30003 Lok… | openFDA enforcement |
| S2 | 06/30 2015 |
injury | — | Proximal tibia fracture in a patient with incomplete spinal cord injury associated with robotic treadmill training · 1 patient | nature.com |