FDA DeviceClass IINotable

FDA Recall: Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300

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

25 units

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