Recall Z-2717-2026— CMR SURGICAL LIMITED
Class II · Ongoing
Class II FDA medical device recall by CMR SURGICAL LIMITED, initiated 2026-06-09. 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
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.