Revolution Apex Plus CT System Security Vulnerability Recall
GE HealthCare is recalling Revolution Apex Plus X-ray CT systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link. Eleven units are affected 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 of a medical device. No reported illnesses, injuries, or security breaches are documented in the source text; the vulnerability is described as "potential" with no confirmed harm or exploitation. This falls under a voluntary precautionary recall due to a security concern without documented adverse consequences.
Plain-English summary
GE Medical Systems, LLC is recalling the Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25, due to 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. A total of 11 units with specific serial numbers have been distributed nationwide in the United States and worldwide.
The source text does not specify the nature of the security risk, the potential impact of the vulnerability, or any reported incidents. Healthcare facilities and clinicians using affected devices should contact GE HealthCare directly for guidance on remediation, updates, or further instructions.
The recalled product
- Product
- Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- security-vulnerability
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: 00195278502179
Distribution
Distributed nationwide across the United States.