Official recall notice
FDA DeviceClass IINotable
Revolution Apex Elite X-ray Computed Tomography Recall (May 2026)
Product: Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
- Recall date
- 2026-05-20
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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 description
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.