CMR SURGICAL LIMITED recalls Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/…

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

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 regulatory.external@cmrsurgical.com or via your local representative.

• FDA enforcement recordOfficial FDA database entry for Z-2717-2026
• FDA 510(k) clearance · K252111The device's official FDA premarket clearance record
• FDA device classification · SCVOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4964The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find CMR SURGICAL LIMITEDSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.