Recall Ledger

Revolution CT ES recall (GE Medical Systems, LLC)

Medical deviceClass IIOngoing

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

What is being recalled

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

Why

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Worldwide - US Nationwide distribution.

How to tell if yours is affected

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

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-2153-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedMarch 26, 2026
ReportedMay 20, 2026
CompanyGE Medical Systems, LLC
Company locationWaukesha, WI, United States
Initiated byVoluntary: Firm initiated
Quantity10 units

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Official FDA record