Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Numbe
- Recall date
- 2026-07-15
- Brand
- CMR SURGICAL LIMITED
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Product description
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Affected products
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.