CLASS II Device recall · Reported 4 Nov 2020 · FDA Enforcement Report

Revolution Apex, Revolution CT with Apex Edition recalled

GE Healthcare is recalling Revolution Apex, Revolution CT with Apex Edition, distributed nationwide in the US. The recall was initiated on 21 Sep 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 5995000-5; Lot/Serial Numbers as below: REVVX1800093CN REVVX1700044CN REVVX1900040CN REVVX2000001CN REV2A1900002CN REV2A2000014CN REVVX2000031CN REV2A2000013CN REVVX1600023CN REVVX1800015CN REVVX1900092CN REV2A2000006CN REVVX1900003CN REV2A2000003CN REV2A2000015CN REV2A1900003CN REVVX1800061CN REV2A2000007CN REVVX1700078CN REVVX1900071CN REVVX1900006CN REVVX1900003CN REVVX1800124CN REVVX1800030CN 441066CN8 00000436942CN7 REV2A2000010CN 00000442968CN4 REVVX1900049CN 00000439505CN9 REVVX1700064CN 00000440315CN0 REV2A2000017CN DUMFMI25490001 REV2A2000001CN 00000442412CN3 REV2A2000002CN REVVX1700054CN REVVX1800100CN REV2A2000012CN REVVX1800040CN REVVX1600046CN REV2A2000016CN REGGL2000003YC REVVX1900013CN REVVX1600030CN REV2A1900001CN REVVX1700117CN REVVX1800083CN REVVX1700106CN 00000440441CN4 REV2A2000018CN REV2A1900005CN REV2A2000009CN 00000438438CN4 REVVX1900102CN REV2A2000011CN REV2A2000004CN DUMFMI25490005 4 included units with lot/serials not available.

Quantity recalled64 devices

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-0306-2021
FDA event ID: 86544
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 21 Sep 2020
FDA classified: 29 Oct 2020
Reported: 4 Nov 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

21 Sep 2020	Recall initiated by company
29 Oct 2020	Classified by FDA	+38 days
4 Nov 2020	Published in enforcement report	+6 days

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

Reason for recall

There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.

Product as listed by the FDA

Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Where it was distributed

Worldwide distribution - US Nationwide distribution including in the states of FL, GA, IL, MI, NC, NE, NJ, PA, TX, VA, WA, and WI. The countries of Australia, Austria, Belgium, Canada, China, Denmark, Estonia, Finland, France, Japan, Kuwait, Norway, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, and United Kingdom.

Nationwide Florida Georgia Illinois Michigan North Carolina Nebraska New Jersey Pennsylvania Texas Virginia Washington Wisconsin

Questions about this recall

Why was it recalled?

There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.

Which lots are affected?

Model 5995000-5; Lot/Serial Numbers as below: REVVX1800093CN REVVX1700044CN REVVX1900040CN REVVX2000001CN REV2A1900002CN REV2A2000014CN REVVX2000031CN REV2A2000013CN REVVX1600023CN REVVX1800015CN REVVX1900092CN REV2A2000006CN REVVX1900003CN REV2A2000003CN REV2A2000015CN REV2A1900003CN REVVX1800061CN REV2A2000007CN REVVX1700078CN REVVX1900071CN REVVX1900006CN REVVX1900003CN REVVX1800124CN REVVX1800030CN 441066CN8 00000436942CN7 REV2A2000010CN 00000442968CN4 REVVX1900049CN 00000439505CN9 REVVX1700064CN 00000440315CN0 REV2A2000017CN DUMFMI25490001 REV2A2000001CN 00000442412CN3 REV2A2000002CN REVVX1700054CN REVVX1800100CN REV2A2000012CN REVVX1800040CN REVVX1600046CN REV2A2000016CN REGGL2000003YC REVVX1900013CN REVVX1600030CN REV2A1900001CN REVVX1700117CN REVVX1800083CN REVVX1700106CN 00000440441CN4 REV2A2000018CN REV2A1900005CN REV2A2000009CN 00000438438CN4 REVVX1900102CN REV2A2000011CN REV2A2000004CN DUMFMI25490005 4 included units with lot/serials not available.

Where was it sold?

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.

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