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Open, Classified

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.

FDA Recall Z-2717-2026 · Posted 2026-07-09

Recalling FirmCMR SURGICAL LIMITED
Recall StatusOpen, Classified
Product CodeSCV
Date Initiated2026-06-09
Product Quantity2

Reason for Recall

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

Firm Action

On June 16, 2026, the firm began notifying affected customers. The firm or its local distributor will proactively carry out the secure boot configuration of the affected consoles. ***Update*** On July 8, 2026, the firm issued an updated letter which clarified the potential risk and instructions for the user. Users were instructed to keep the device in a secure environment with restricted access whether it was in clinical use or not. Users should inspect the system for signs of damage or interference before each use. Tamper-evident labels are located on the casework and will become damaged in the event of unauthorized access. Do not use the system if there is any damage or visible signs of interference on the tamper-evident labels and report immediately to CMR Surgical directly on [email protected] or via your local representative.

Root Cause

Software design (manufacturing process)

Distribution Pattern

US Nationwide distribution in the state of California.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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