Products: Surgical robot. Risk band: Elevated RobotRisk index 29.6/100 (incidents/exposure, time-weighted) · 98th percentile of 162 medical robotics companies.
CMR Surgical's record shows a single entry: a June 9, 2026 Class II recall of the Versius surgeon console tied to a disabled Secure Boot cybersecurity control, rated severity 2. This one event produces an index of 29.9, placing the company at the 97.5th percentile within medical-robotics, a category where recalls and cybersecurity findings carry outsized weight. The record is regulator-driven, centered on a cybersecurity control rather than a mechanical or clinical malfunction. No additional events are on file, so the standing reflects a single recall rather than a sustained pattern.
| Sev | Date | Type | Location | Incident | Source |
|---|---|---|---|---|---|
| S4 | 09/2026 | regulatory | — | FDA MAUDE record 2020-2026: 0 death, 3 injury, 186 malfunction reports · 189 reports | openFDA MAUDE |
| S2 | 06/09 2026 |
recall | — | Class II recall of Versius surgeon console over disabled Secure Boot cybersecurity control · 2 units distributed in the US (Califor… | FDA |
| Sev | Date | Type | Report | Source |
|---|---|---|---|---|
| S3 | 07/2026 | injury | MAUDE injury report 3015488559-2026-00135 (Versius) · MDR 3015488559-2026-00135 | openFDA MAUDE |
| S3 | 06/2026 | injury | MAUDE injury report 3015488559-2026-00067 (Versius) · MDR 3015488559-2026-00067 | openFDA MAUDE |
| S3 | 05/2026 | injury | MAUDE injury report 3015488559-2026-00018 (Versius) · MDR 3015488559-2026-00018 | openFDA MAUDE |