GE Medical Systems, LLC — Class II: Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
GE Medical Systems, LLC has initiated a Class II recall for the Revolution CT ES (Model 5590000-15) due to a potential security vulnerability. The issue impacts the AW Server when deployed via Edison Health Link (EHL) based CT Smart Subscription in conjunction with specific Revolution series CT systems.
This affects healthcare facilities using GE Revolution Apex, Revolution Ascend, and Revolution CT systems configured with AW Server via Edison Health Link, as well as regulatory and IT security departments responsible for diagnostic imaging infrastructure.
The classification of a cybersecurity vulnerability as a Class II recall indicates that while the risk may not be immediate or life-threatening, it requires formal remediation to prevent potential compromise of device functionality or data integrity. This highlights the ongoing regulatory focus on software vulnerabilities in networked medical devices and the necessity for robust vulnerability management programs within the manufacturer's post-market lifecycle.
Impacted organizations should identify the specific model number (5590000-15) and deployment configuration within their fleet. IT and security teams should coordinate with the manufacturer to apply necessary patches or mitigations for the AW Server and Edison Health Link environment. QA departments should document these activities within their post-market surveillance and CAPA systems.
Class II. Reason: GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.. Product: Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15. Firm: GE Medical Systems, LLC (Waukesha WI United States). Status: Ongoing.
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