TemporaryFDAOngoing
Can cause harm that is usually temporary.
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.
Check the device or its packaging for
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.
- Why
- Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
- Distributed
- US Nationwide distribution in the state of California.
- Company
- CMR SURGICAL LIMITED
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2717-2026 · retrieved 9 July 2026
Read the official notice