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GE Medical Systems, LLC: Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15

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 CT ES, X-ray Computed Tomography, Model Number 5590000-15
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: 00840682123471; Serial Numbers: REVV82200058CN REVV82200046CN REVV82100016CN REVV82200014CN REVV82100027CN REVV82200047CN REVV82100031CN REVV82400010CN REVV82200017CN REVV82400005CN
Product quantity
10 units
Voluntary mandated
Voluntary: Firm initiated
City
Waukesha
State
WI
Country
United States
Event id
98738
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