CLASS II ONGOING Device recall · Reported 1 Dec 2021 · FDA Enforcement Report

Computed Tomography Systems Revolution CT, Revolution CT ES recalled

GE Healthcare is recalling Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution, distributed nationwide in the US. The recall was initiated on 30 Jun 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesRevolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

Quantity recalled105 in total

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-0242-2022
FDA event ID: 89027
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 30 Jun 2021
FDA classified: 24 Nov 2021
Reported: 1 Dec 2021
Type: FDA Mandated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

30 Jun 2021	Recall initiated by company
24 Nov 2021	Classified by FDA	+147 days
1 Dec 2021	Published in enforcement report	+7 days

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

Reason for recall

The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will show a value that is higher (up to 100 times) than the actual dose delivered.

Product as listed by the FDA

Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

Where it was distributed

Worldwide and US Nationwide Distribution

Nationwide

Questions about this recall

Is Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution recalled?

Yes. GE Healthcare recalled Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution on 30 Jun 2021. The recall is Class II and its status is Ongoing. Recall number Z-0242-2022.

Why was it recalled?

Which lots are affected?

Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

Where was it sold?

Worldwide and 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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