CMR SURGICAL LIMITED recalls Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US
- Recalling company
- CMR SURGICAL LIMITED
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jun 9, 2026
- Reported
- Jul 15, 2026
- Distribution
- US Nationwide distribution in the state of California.
- Status
- Ongoing
- Quantity
- 2
- Lot / codes
- 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.
- Company location
- Cambridge, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2717-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2717-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.