CLASS II ONGOING Device recall · Reported 13 Apr 2022 · 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 30 Jun 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesRevolution Apex, Revolution CT with Apex Edition

Quantity recalled273 (51 US, 222 OUS) 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-0815-2022
FDA event ID: 89762
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 30 Jun 2021
FDA classified: 5 Apr 2022
Reported: 13 Apr 2022
Type: FDA Mandated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

30 Jun 2021	Recall initiated by company
5 Apr 2022	Classified by FDA	+279 days
13 Apr 2022	Published in enforcement report	+8 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. There are two situations that will result in the SmartStep displayed dose being inaccurately high.

Product as listed by the FDA

Revolution Apex, Revolution CT with Apex Edition

Where it was distributed

Worldwide - US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.

Which lots are affected?

Revolution Apex, Revolution CT with Apex Edition

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

1 other product · FDA event 89762

Reported	Class	Recall	Company	Reason	Where
13 Apr 2022	CLASS II	Revolution CT, Revolution CT ES recalled by GE Healthcare	GE Healthcare	Labeling Errors	Nationwide

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