FDA-Device2026-05-20Class IIPROCESSING DEFECT

GE Revolution Apex CT scanner recalled for AW Server security vulnerability

OTHERNationwide distributionMedical devices

What this means

GE HealthCare identified a security vulnerability in the AW Server software used with certain Revolution Apex, Revolution Ascend, and Revolution CT imaging systems when deployed through Edison Health Link. The vulnerability could potentially allow unauthorized access to the server. No injuries have been reported.

  • If you operate one of the affected CT systems, contact GE HealthCare for guidance on the security vulnerability and available patches or mitigations.
  • Check your system's serial number against the list provided by GE HealthCare to confirm if your equipment is affected.
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The agency's original wording
Hazard

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.

Intended for
All ages
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution.
Affected count
24 units
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2154-2026

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