Revolution CT X-ray Computed Tomography System Security Vulnerability Recall
GE HealthCare is recalling Revolution CT x-ray computed tomography systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription. The vulnerability affects certain Revolution Apex, Revolution Ascend, and Revolution CT systems worldwide.
What this means for you
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 software security vulnerability with no reported illnesses, injuries, or confirmed exploitation. Security vulnerabilities in medical devices are precautionary recalls; without evidence of harm or active exploitation, the hazard remains theoretical.
Plain-English summary
GE HealthCare has identified a potential security vulnerability impacting the AW Server when deployed via Edison Health Link (EHL) based CT Smart Subscription. This vulnerability affects certain Revolution Apex, Revolution Ascend, and Revolution CT systems, including 38 units of the Revolution CT (Model Numbers 5590000 and 5590000-6) that were distributed nationwide and worldwide.
The recall involves specific serial numbers identified by GE HealthCare, with UDI-DI 00840682118552. Affected units include systems manufactured by GE Medical Systems, LLC.
Healthcare providers and facilities using these systems should contact GE HealthCare for instructions regarding the security vulnerability and any necessary remediation or mitigation steps.
The recalled product
- Product
- Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- Affected units
- 38
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: 00840682118552
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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