Products: rehab-exoskeleton. Risk band: Low RobotRisk index 13.2/100 (incidents/exposure, time-weighted) · 91th percentile of 162 medical robotics companies.
The record contains one entry: an FDA Class II recall of the Trexo pediatric robotic gait-training device, dated May 2023, coded at severity 3. Class II denotes a recall where use of the device may cause temporary or reversible harm, a step below the highest FDA severity tier. Trexo's index (13.4) and percentile (91.3, low band) place it in the lower tier of the medical-robotics category. The record is a single regulator-driven action with no additional incidents recorded.
| Sev | Date | Type | Location | Incident | Source |
|---|---|---|---|---|---|
| S3 | 05/31 2023 |
recall | — | FDA Class II recall: Trexo Device · Trexo Device | openFDA enforcement |