Revolution Apex Elite X-ray CT System Security Vulnerability Recall
GE HealthCare is recalling certain Revolution Apex Elite X-ray computed tomography systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link. The vulnerability may affect data security in CT Smart Subscription systems.
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 medical device recall involving a potential security vulnerability with no reported illnesses or injuries. Security vulnerabilities in medical devices are concerns but fall below the threshold of high-risk pathogen contamination or reported harm, placing this in the Moderate category.
Plain-English summary
GE Medical Systems, LLC has recalled 33 units of the Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 due to a potential security vulnerability. The vulnerability impacts the AW Server when deployed via Edison Health Link (EHL) in conjunction with CT Smart Subscription features.
The affected systems were distributed worldwide with nationwide distribution in the United States. The specific serial numbers and UDI-DI identifier (00195278460271) are listed in the recall notice to help identify affected devices.
Affected hospitals and medical facilities using the identified serial numbers should contact GE HealthCare for guidance on remediation or corrective actions. Users can reference FDA recall number Z-2151-2026 and the list of affected serial numbers to determine if their system is included in this recall.
The recalled product
- Product
- Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- security-vulnerability
- data-breach-risk
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: 00195278460271
Distribution
Distributed nationwide across the United States.