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CLASS II · ModerateFDA

GE Medical Systems, LLC recalls Revolution Apex Elite

📅 Mar 26, 2026 · 📍 Nationwide
Recalling company
GE Medical Systems, LLC
Product
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Mar 26, 2026
Reported
May 20, 2026
Distribution
Worldwide - US Nationwide distribution.
Status
Ongoing
Quantity
33 units
Lot / codes
UDI-DI: 00195278460271; Serial Numbers: REV2X2400067CN REV2X2400065CN REV2X2400046CN REV2X2400021CN REV2X2400050CN REV2X2400095CN REV2X2400078CN REV2X2300068CN REV2X2400093CN REV2X2400098CN REV2X2300091CN REV2X2300042CN REV2X2300083CN REV2X2300020CN REV2X2400068CN REV2X2400107CN REV2X2300090CN REV2X2300097CN REV2X2300003CN REV2X2400028CN REV2X2400026CN REV2X2300002CN REV2X2400027CN REV2X2400059CN REV2X2300084CN REV2X2400069CN REV2X2400063CN REV2X2400055CN REV2X2300011CN REV2X2300050CN REV2X2400048CN REV2X2300047CN REV2X2400014CN
Company location
Waukesha, WI
Recall type
Voluntary: Firm initiated
Recall number
Z-2151-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2151-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.