← Back to recalls

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.

Class II
Recalling firm
CMR SURGICAL LIMITED
Reason for recall
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Affected products (lot / model / serial)
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.
Units affected
2
Distribution pattern
US Nationwide distribution in the state of California.
Firm location
Cambridge, N/A, United Kingdom
Recall type
Voluntary: Firm initiated
How the firm notified customers
E-Mail
Product type
Devices
Status
Ongoing
Recall number
Z-2717-2026
Recall initiated
June 9, 2026
FDA classification date
July 9, 2026
FDA report date
July 15, 2026
FDA event ID
99280
Last updated on HTM Vibe
July 23, 2026
View on openFDA