Reported Jul 15, 2026 · Ongoing
Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software…
Cmr Surgical Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CMR SURGICAL LIMITED · 1 Evolution Business Park · Cambridge, N/A · N/A
Is this the product you have?
- Brand NameVersius
- Surgical System US Product NameVesius
- Surgeon Console US Model/Catalog NumberV-SS-1020
- Software VersionPratchett 1 version 62.1
- Product DescriptionThe Versius Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery
- Lot codes and dates
- 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.
- Amount recalled
- 2
Where it was sold
- Nationwide
- CA
Why it was recalled
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
This product could cause temporary or reversible health problems — stop using it.
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