Products: Surgical robot. Risk band: Elevated RobotRisk index 38.6/100 (incidents/exposure, time-weighted) · 98th percentile of 162 medical robotics companies.
The record shows one entry: a Class I recall of the Senhance surgical robot for unintended arm movement, dated September 2023. Class I is the FDA's highest-severity recall category, denoting a defect with potential for serious injury or death, consistent with the severity-3 coding here. Asensus carries the highest index (38.9) and percentile (98.1, elevated band) among the medical-robotics entities listed, indicating a materially worse standing than category peers on this metric. The record is a single regulator-driven action; no repeat incidents or additional events are recorded.
| Sev | Date | Type | Location | Incident | Source |
|---|---|---|---|---|---|
| S4 | 09/2026 | regulatory | — | FDA MAUDE record 2020-2026: 0 death, 15 injury, 13 malfunction reports · 28 reports | openFDA MAUDE |
| S3 | 09/15 2023 |
recall | — | Class I recall of Senhance surgical robot over unintended arm movement · 5 devices in the US, distributed April… | FDA |