FDAClass II · Medical device · Recalled July 15, 2026

Brand Name recall — CMR SURGICAL LIMITED

Hazard: Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2717-2026
Brand: CMR SURGICAL
Classification: Class II
Units affected: 2
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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.

Affected products

Brand Name

Companies & origin

Recalling firm location: Cambridge, N/A, United Kingdom
Firm address: 1 Evolution Business Park, Milton Road; Cam, N/A

Identifying details (verbatim from the notice)

Product 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.
Distribution: US Nationwide distribution in the state of California.
Firm notified the public via: E-Mail
FDA event ID: 99280
Recall initiated: June 9, 2026
FDA classified: July 9, 2026
FDA report date: July 15, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 10:42 PM UTC.

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