Brand Name: Versius Surgical System US Product Name: Vesius Surgeon… — Class II medical device recall Z-2717-2026
Ongoing recall by CMR SURGICAL LIMITED, reported 2026-07-15, distributed nationwide. Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
| Recall number | Z-2717-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CMR SURGICAL LIMITED, Cambridge, N/A, United Kingdom |
| Recall initiated | 2026-06-09 |
| Classified | 2026-07-09 |
| Reported by FDA | 2026-07-15 |
| Distributed | Nationwide (US) |
| Quantity | 2 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05060548211226 |
| Serial numbers | 66495, 66496 |
| Model numbers | V-SS-1020 |
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.
Reason for recall
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2717-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.