FDA DeviceClass IINotable

FDA Recall: Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27

Date: 2026-05-20
Brand: GE Medical Systems, LLC
Category: Medical Device
FDA Class: Class II

Description

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

Hazard

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

Remedy

5 units

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