Recall Z-2717-2026— CMR SURGICAL LIMITED

Name: FDA recall Z-2717-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-09

Class II · Ongoing

Class II FDA medical device recall by CMR SURGICAL LIMITED, initiated 2026-06-09. It names one FDA 510(k) clearance: K252111. 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.. Reason: Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk..

Recalling firm: CMR SURGICAL LIMITED
Classification: Class II
Status: Ongoing
Initiated: 2026-06-09
Firm location: Cambridge, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K252111 — Versius Surgical System (Versius Plus)Cmr Surgical Limited·cleared 2025-12-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.