Revolution Apex Select CT systems subject to software security vulnerability recall
GE HealthCare is recalling Revolution Apex Select and related CT systems due to a security vulnerability in the AW Server software deployed via Edison Health Link-based CT Smart Subscription.
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 device recall involving a software security vulnerability with no reported illnesses or injuries. The hazard is cybersecurity-related rather than a direct health or safety risk, and the source contains no evidence of actual harm or exploitation.
Plain-English summary
GE Medical Systems, LLC is recalling certain Revolution Apex Select, Revolution Ascend, and Revolution CT systems due to a potential security vulnerability in the AW Server software. The vulnerability affects systems using the Edison Health Link (EHL)-based CT Smart Subscription feature.
Five units with the following serial numbers have been identified: REV242400001CN, REV242400004CN, REV242300006CN, REV242400002CN, and REV242300004CN (UDI-DI: 00195278469700). These systems have been distributed nationwide and worldwide.
Affected facilities using these systems should contact GE HealthCare for guidance on remediation or updates to address the security vulnerability.
The recalled product
- Product
- Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
- Manufacturer
- GE Medical Systems, LLC
- Affected units
- 5
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: 00195278469700
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.
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