RecallRadar

FDA Device recall Z-2153-2026

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

On 2026-05-20 the FDA classified a Class II recall of Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15 by Ge Medical Systems, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2153-2026
ClassificationClass II
Statusongoing
Initiated2026-03-26
Published2026-05-20
Last updated2026-09-13 11:58 UTC
CompanyGe Medical Systems
DistributionUS

Product

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.

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2153-2026%22

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