Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2154-2026·Announced 2026-05-20

Revolution Apex X-ray CT System Security Vulnerability Recall

GE HealthCare is recalling Revolution Apex, Revolution Ascend, and Revolution CT systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link-based CT Smart Subscription. The vulnerability may impact system security.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving a security vulnerability with no reported adverse health consequences or patient harm. Per the rubric, recalls addressing theoretical security risks without reported illnesses or injuries typically fall into the Moderate category.

Plain-English summary

GE HealthCare has identified a potential security vulnerability affecting the AW Server when deployed via Edison Health Link (EHL) based CT Smart Subscription in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT imaging systems.

The recall applies to 24 units of the Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20, which are distributed nationwide across the United States and worldwide. Affected serial numbers are listed in the recall documentation, and the product can be identified by UDI-DI: 00840682146616.

Customers operating affected CT systems should contact GE HealthCare to verify whether their device is impacted and to obtain guidance on remediation or security updates. No reported injuries or adverse events are mentioned in this recall notice.

The recalled product

Product: Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
Manufacturer: GE Medical Systems, LLC
Category: Medical Device — Computed Tomography System
Hazard: security-vulnerability
Affected units: 24

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

UDI-DI: 00840682146616

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · GE Medical Systems, LLC

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