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CMR SURGICAL LIMITED — Class II: Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Cat

MediumPublished Jul 15, 2026· AI-analyzed Jul 22, 2026View original FDA source

AI-generated regulatory interpretation. The four sections below are an analyst-style summary produced by an AI model from the original FDA source. Always verify against the source before any regulatory, clinical, or commercial decision.

What happened

CMR Surgical Limited has initiated a Class II recall for the Versius Surgical System (Surgeon Console US, Model V-SS-1020, Software Version Pratchett 1 version 62.1) because Secure Boot was not enabled during manufacturing. This oversight presents a potential cybersecurity vulnerability for the modular electromechanical system.

Who it affects

This affects CMR Surgical Limited, users of the Versius Surgical System US, and manufacturing personnel responsible for software installation and security configuration of life science robotics.

Why it matters

The failure to enable Secure Boot suggests a gap between design specifications and manufacturing execution. From a regulatory perspective, this highlights the necessity for robust post-market oversight regarding software integrity. Although no patient harm is noted in the source, cybersecurity vulnerabilities in surgical systems can potentially impact device availability or data integrity, necessitating rigorous CAPA investigations into manufacturing process controls.

Practical takeaway

QA and manufacturing teams should verify that all cybersecurity-related features specified in design outputs, such as Secure Boot, are successfully validated before product release. Regulatory teams may need to review manufacturing execution system (MES) controls to ensure software security configurations are correctly flashed and verified during the production cycle.

FDA source material

Class II. Reason: Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.. Product: Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery.. Firm: CMR SURGICAL LIMITED (Cambridge N/A United Kingdom). Status: Ongoing.

Open in openFDA / FDA.gov

AI-generated interpretation. Always verify critical decisions against the original FDA source. Generated with google/gemini-3-flash-preview.

CMR SURGICAL LIMITED — Class II: Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Cat

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