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Recall Observatory FDA recall evidence

Device product

Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25

Z-2152-2026

March 26, 2026

Class II

Product summary

Firm
GE Medical Systems, LLC
Event
Event 98738
Status
Ongoing
Classification
Class II
Quantity
11 units
Official record key
device-enforcement:Z-2152-2026

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: 00195278502179; Serial Numbers: REV282400012CN REV282400006CN REV282400038CN REV282400011CN REV282400003CN REV282400013CN REV282300006CN REV282400021CN REV282300013CN REV282400035CN REV282300022CN

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.