FDA-Device2026-05-20Class IIPROCESSING DEFECT

GE Revolution Apex Elite CT scanner recalled for AW Server security vulnerability

OTHERNationwide distribution

GE Revolution Apex Elite CT scanner has security vulnerability

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 the Edison Health Link subscription service. The vulnerability could potentially allow unauthorized access to the system. No patient harm has been reported.

  • If your facility operates one of the affected CT systems, contact GE HealthCare technical support for a security patch or updated software
  • Check the serial number list provided in the full recall notice to confirm whether your equipment is affected
  • Do not delay routine CT imaging while awaiting the fix; the vulnerability is a security concern, not a patient safety hazard
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.

Sold states
Worldwide - US Nationwide distribution.
Affected count
33 units
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2151-2026

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