FDA Medical devices recall ·
Versius Surgical System US Product Name: Vesius Surgeon Console US Model recall
- Recall number
- Z-2717-2026
- Date
- (initiated June 9, 2026)
- Company / brand
- Cmr Surgical Limited
1 Evolution Business Park, Cambridge, N/A, United Kingdom - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
US Nationwide distribution in the state of California.
States: California
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2717-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.