FDA recall Z-2717-2026

CMR SURGICAL LIMITED · Class II · device

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 for recall

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

Distribution

US Nationwide distribution in the state of California.

Key facts

Status
Ongoing
Initiation date
2026-06-09
Report date
2026-07-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cambridge, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2717-2026