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GE Medical Systems, LLC: Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25

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

Read the official notice at FDA (device) →

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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 Plus, X-ray Computed Tomography, Model Number 5590000-25
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: 00195278502179; Serial Numbers: REV282400012CN REV282400006CN REV282400038CN REV282400011CN REV282400003CN REV282400013CN REV282300006CN REV282400021CN REV282300013CN REV282400035CN REV282300022CN
Product quantity
11 units
Voluntary mandated
Voluntary: Firm initiated
City
Waukesha
State
WI
Country
United States
Event id
98738
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