Medical device recalls Moderate risk

GE Medical Systems, LLC recalls Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300

Recall date
March 26, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2149-2026
FDA classification
Class II
Brand / firm
GE Medical Systems, LLC
Sold / distributed
Worldwide - US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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