FDA DeviceClass IINotable

FDA Recall: Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6

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

38 units

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