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GE Medical Systems, LLC: Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27

Medical DevicesSource: FDA (device) · Date: 2026-05-20

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
GE Medical Systems, LLC
Product
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution.
Recall initiated
2026-03-26
Code info
UDI-DI: 00195278469700; Serial Numbers: REV242400001CN REV242400004CN REV242300006CN REV242400002CN REV242300004CN
Product quantity
5 units
Voluntary mandated
Voluntary: Firm initiated
City
Waukesha
State
WI
Country
United States
Event id
98738
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