FDAFDA · Food and drugs·Recall number Z-2717-2026
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.
Published July 15, 2026 · Recall initiated: June 9, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- CMR SURGICAL LIMITED
- Distributor
- US Nationwide distribution in the state of California.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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