FDA DeviceClass IINotable

FDA Recall: Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Numbe

Date: 2026-07-15
Brand: CMR SURGICAL LIMITED
Category: Medical Device
FDA Class: Class II

Description

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

Hazard

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

Remedy

2

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