Products: surgical-robot. Risk band: Elevated RobotRisk index 17.3/100 (incidents/exposure, time-weighted) · 93th percentile of 162 medical robotics companies.
The record consists of a single FDA Class II recall for the MIRA surgical system, a table-mounted electromechanical robotic surgical device. Severity is rated 3, and the entry places the company at the 93.2nd percentile within medical-robotics, an elevated band. The record is regulator-driven, originating from an FDA classification rather than press reporting, and reflects one isolated event rather than a repeated pattern. No malfunction, injury, or fatality data accompanies the recall entry.
| Sev | Date | Type | Location | Incident | Source |
|---|---|---|---|---|---|
| S3 | 04/23 2025 |
recall | — | FDA Class II recall: MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical sur · MIRA SURGICAL SYSTEM, Table mounted mi… | openFDA enforcement |