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Recall Observatory FDA recall evidence

Device product

Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27

Z-2155-2026

March 26, 2026

Class II

Product summary

Firm
GE Medical Systems, LLC
Event
Event 98738
Status
Ongoing
Classification
Class II
Quantity
5 units
Official record key
device-enforcement:Z-2155-2026

Official wording

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.

Code information: UDI-DI: 00195278469700; Serial Numbers: REV242400001CN REV242400004CN REV242300006CN REV242400002CN REV242300004CN

Distribution pattern: Worldwide - US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.