Class II — CMR SURGICAL LIMITED
| Recalling firm | CMR Surgical Limited |
|---|---|
| Registered facility | CMR SURGICAL LIMITED (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk. |
| 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. |
| Quantity | 2 |
| Distribution | US Nationwide distribution in the state of California. |
| Initiated | 2026-06-09 |
| Classified | 2026-07-09 |
| Recall number | Z-2717-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CMR SURGICAL LIMITED (Z-2717-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99280/
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