Z-2717-2026 Class II Ongoing
FDA device recall Z-2717-2026 was initiated by CMR SURGICAL LIMITED on June 9, 2026 and is designated Class II. Reason for recall: Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk. The recall status is ongoing. Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2026
- Initiation Date
- June 9, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product 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.
Reason for Recall
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Distribution Pattern
US Nationwide distribution in the state of California.
Code Information
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.