Recall Z-2717-2026 ยท SCV Modular Electromechanical Surgical System
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: The Versius Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery.
| Date | Jul 9, 2026 (initiated Jun 9, 2026) |
| Status | Open, Classified |
| Reason | Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk. |
| Root cause | Software design (manufacturing process) |
| Action | 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. ***Update*** On July 8, 2026, the firm issued an updated letter which clarified the potential risk and instructions for the user. Users were instructed to keep the device in a secure environment with restricted access whether it was in clinical use or not. Users should inspect the system for signs of damage or interference before each use. Tamper-evident labels are located on the casework and will become damaged i |
| Quantity | 2 |
| Distribution | US Nationwide distribution in the state of California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K252111 | Versius Surgical System (Versius Plus) Cmr Surgical Limited, Dec 16, 2025 |