CMR Surgical safety record

Incidents

• FDA clears CMR Surgical Versius Plus robotic surgical system for gallbladder removal procedures2026-07-01

  Regulatory action · severity: minor · FDA · other

• CMR Surgical recalls Versius Surgical System consoles due to Secure Boot cybersecurity vulnerability2026-06-09

  Recall · severity: moderate · FDA · recall ordered

• CMR Surgical Versius: hand-controller arm went still and console became unrecoverable, forcing open conversion (FDA MAUDE)2026-04-07

  Malfunction · severity: serious · FDA (MAUDE)

• CMR Surgical Versius Plus receives FDA 510(k) clearance for gallbladder surgery2026-03-15

  Regulatory action · severity: minor · FDA · other

• FDA clears CMR Surgical Versius Plus surgical robotic platform for cholecystectomy (510(k))2025-12-17

  Regulatory action · severity: minor · FDA · other

Exposure

DEPLOY does not have exposure data (deployment-hours, miles driven, or rides given) on file for CMR Surgical's 4 recorded deployments. This is a genuine data gap, not a rounding to zero: no incident count above can be turned into a defensible rate without it. NHTSA's SGO dataset itself does not publish exposure denominators, and there is no standardized, regulator-verified nationwide source for AV fleet mileage or ride counts today. Where a company self-publishes a mileage figure, it is not independently audited and is not shown here as DEPLOY-verified data.

A note on NHTSA's crash-reporting data

Many of the incidents below are drawn from NHTSA's Standing General Order (SGO) 2021-01 crash-reporting program, which requires manufacturers and operators of automated driving systems (ADS) and advanced driver-assistance systems (ADAS) to report qualifying crashes. It is the only nationwide, cross-operator crash dataset that exists for this industry, and it is also, by NHTSA's own design and Consumer Reports' public assessment, an imperfect one.

Reporting companies may redact narrative fields as confidential business information (CBI). In practice this means narrative completeness is uneven across manufacturers in the underlying dataset: some incident reports read as full prose descriptions of what happened, others are replaced with boilerplate redacted text. This is a property of the source data, not of DEPLOY's editorial process; DEPLOY publishes what the filing discloses and states plainly when a fuller account is not publicly available.

The SGO dataset also does not publish exposure denominators (miles driven, hours operated, rides given) alongside crash counts, so a raw incident count cannot be turned into a rate without an independently sourced denominator. See "Exposure" below for what DEPLOY does and does not have on file for this company.

• NHTSA: Standing General Order on Crash Reporting ↗
• Consumer Reports: comments to NHTSA on incident reporting for ADS and Level 2 ADAS ↗
• Consumer Reports: statement on crash-reporting underreporting ↗

Common questions