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

Revolution Ascend, computed tomography recalled by GE Medical Systems

GE Medical Systems is recalling Revolution Ascend, 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: 00840682146173; Serial Numbers: AS10G2200136YC AS10G2200101YC AS10G2200068YC AS10G2200035YC AS10G2300093YC AS10G2400094YC AS10G2400079YC AS10G2100008YC AS10G2500002YC CBDWG2400019HM CBDWG2300081HM AS10G2400056YC AS10G2400081YC AS10G2400087YC CBDWG2400117HM CBDWG2400085HM CBDWG2500003HM CBDWG2400140HM CBDWG2400126HM AS10G2200085YC AS10G2300057YC CBDWG2500011HM CBDWG2300056HM CBDWG2300041HM AS10G2300041YC

Quantity recalled25 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-2149-2026
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: Other Medical Devices

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 Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300

Where it was distributed

Worldwide - US Nationwide distribution.

Nationwide

Questions about this recall

Is Revolution Ascend, computed tomography recalled?

Yes. GE Medical Systems recalled Revolution Ascend, computed tomography on 26 Mar 2026. The recall is Class II and its status is Ongoing. Recall number Z-2149-2026.

Why was it recalled?

Which lots are affected?

UDI-DI: 00840682146173; Serial Numbers: AS10G2200136YC AS10G2200101YC AS10G2200068YC AS10G2200035YC AS10G2300093YC AS10G2400094YC AS10G2400079YC AS10G2100008YC AS10G2500002YC CBDWG2400019HM CBDWG2300081HM AS10G2400056YC AS10G2400081YC AS10G2400087YC CBDWG2400117HM CBDWG2400085HM CBDWG2500003HM CBDWG2400140HM CBDWG2400126HM AS10G2200085YC AS10G2300057YC CBDWG2500011HM CBDWG2300056HM CBDWG2300041HM AS10G2300041YC

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

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