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Recall Observatory FDA recall evidence

Device product

Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15

Z-2153-2026

March 26, 2026

Class II

Product summary

Firm
GE Medical Systems, LLC
Event
Event 98738
Status
Ongoing
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-2153-2026

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: 00840682123471; Serial Numbers: REVV82200058CN REVV82200046CN REVV82100016CN REVV82200014CN REVV82100027CN REVV82200047CN REVV82100031CN REVV82400010CN REVV82200017CN REVV82400005CN

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.