FDAHealthJune 9, 2026
CMR SURGICAL LIMITED — 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
⚠️ Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 9, 2026
US Nationwide distribution in the state of California.
What's affected?
- 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.
- Brand
- CMR SURGICAL LIMITED
- Lot code
- 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.
Additional details
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.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2.
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