Reported Jul 15, 2026 · Ongoing

Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software…

Cmr Surgical Limited

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CMR SURGICAL LIMITED · 1 Evolution Business Park · Cambridge, N/A · N/A

Is this the product you have?

  • Brand NameVersius
  • Surgical System US Product NameVesius
  • Surgeon Console US Model/Catalog NumberV-SS-1020
  • Software VersionPratchett 1 version 62.1
  • Product DescriptionThe Versius Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery
Lot codes and dates
  • UDI-DI 05060548211226 Model No V-SS-1020 Serial Numbers 66495, 66496 Software Revision Version 62.1 There is no expiry date for this device.
Amount recalled
2

Where it was sold

  • Nationwide
  • CA

Why it was recalled

Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:41 PM UTC

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