Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US ... recall (CMR SURGICAL LIMITED)
Medical deviceClass IIOngoing
Summary: CMR SURGICAL LIMITED is recalling 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 surg. Reason: Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
What is being recalled
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.
Why
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the state of California. (states named: California)
How to tell if yours is affected
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 to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2717-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 9, 2026 |
| Reported | July 15, 2026 |
| Company | CMR SURGICAL LIMITED |
| Company location | Cambridge, N/A, United Kingdom |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 2 |
More recalls from CMR SURGICAL LIMITED · all medical device recalls · recalls from June 2026