CLASS II ONGOING Device recall · Reported 20 May 2026 · FDA Enforcement Report

Revolution Apex Elite, X-ray Computed Tomography recalled

GE Medical Systems is recalling Revolution Apex Elite, X-ray Computed Tomography, distributed nationwide in the US. The recall was initiated on 26 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-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

Quantity recalled33 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2151-2026
FDA event ID: 98738
Recalling firm: GE Medical Systems, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 26 Mar 2026
FDA classified: 8 May 2026
Reported: 20 May 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

26 Mar 2026	Recall initiated by company
8 May 2026	Classified by FDA	+43 days
20 May 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23

Where it was distributed

Worldwide - US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Worldwide - US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 98738

This product is part of a recall event; the main page for the event is Revolution CT ES, X-ray Computed Tomography recalled.

Reported	Class	Recall	Company	Reason	Where
20 May 2026	CLASS II	Revolution CT ES, X-ray Computed Tomography recalled	GE Medical Systems	Other	Nationwide
20 May 2026	CLASS II	Revolution Ascend, computed tomography recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide
20 May 2026	CLASS II	Revolution Apex Select, X-ray Computed Tomography recalled	GE Medical Systems	Other	Nationwide
20 May 2026	CLASS II	Revolution Apex, X-ray Computed Tomography recalled	GE Medical Systems	Other	Nationwide
20 May 2026	CLASS II	Revolution Apex Plus, X-ray Computed Tomography recalled	GE Medical Systems	Other	Nationwide
20 May 2026	CLASS II	Revolution CT, x-ray computed tomography recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide

More recalls from GE Medical Systems

All 160

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Other Imaging Equipment recalls

All 2,341

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