Ge Medical Systems, Llc: System, X-ray, Tomography, Computed

Recall Summary GE Medical Systems is recalling certain Revolution Apex Elite computed tomography (CT) X-ray systems due to a security vulnerability in the AW Server software when used with Edison Health Link-based CT Smart Subscription services. The vulnerability affects Revolution Apex, Revolution Ascend, and Revolution CT systems distributed nationwide across all U.S. states. This is a Class II recall, meaning the devices pose a potential health risk but are unlikely to cause serious injury.

Recalling firm
GE Medical Systems, LLC
Product
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
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.
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-03-26
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Worldwide - US Nationwide distribution.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/5711c660-106a-4610-b083-2ade50ecc923