Revolution Ascend CT scanner security vulnerability affecting AW Server
GE HealthCare is recalling Revolution Ascend computed tomography systems due to a potential security vulnerability in the AW Server used with Edison Health Link-based CT Smart Subscription. 25 units are affected nationwide.
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: FDA Class II designation applies. The source does not report any actual security breaches, exploitations, or patient harm — only a potential vulnerability. This is a precautionary recall without evidence of realized harm.
Plain-English summary
GE Medical Systems, LLC is recalling Revolution Ascend computed tomography systems, Model Numbers 6969000-100 and 6969000-300, due to a potential security vulnerability affecting the AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription. The vulnerability impacts certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Affected units were distributed nationwide in the United States. A total of 25 units are subject to this recall. The security vulnerability could potentially be exploited, which is why GE HealthCare is taking this precautionary measure.
Customers who have these systems should contact GE HealthCare for guidance on remediation measures and further information regarding this security vulnerability.
The recalled product
- Product
- Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- Affected units
- 25
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: 00840682146173
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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