FDAHealthMarch 26, 2026

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

⚠️ 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.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: March 26, 2026

Worldwide - US Nationwide distribution.

What's affected?

Product: Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
Brand: GE Medical Systems, LLC
Lot code: UDI-DI: 00840682123471; Serial Numbers: REVV82200058CN REVV82200046CN REVV82100016CN REVV82200014CN REVV82100027CN REVV82200047CN REVV82100031CN REVV82400010CN REVV82200017CN REVV82400005CN

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 10 units.

View original FDA notice →

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