Recall Z-2717-2026
CMR Surgical Limited · initiated June 9, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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.
Reason for recall
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
FDA-determined cause: Software design (manufacturing process)
Action taken
On June 16, 2026, the firm began notifying affected customers. The firm or its local distributor will proactively carry out the secure boot configuration of the affected consoles.
Details
- Recall number
- Z-2717-2026
- Initiated
- June 9, 2026
- Posted by FDA
- July 9, 2026
- Product code
- SCV – Modular Electromechanical Surgical System
- Quantity
- 2
- Distribution
- US Nationwide distribution in the state of California.
- Recalling firm
- CMR Surgical Limited, Cambridge