CLASS II Device recall · Reported 30 Dec 2020 · FDA Enforcement Report

Revolution CT with Apex Edition CT System recalled by GE Healthcare

GE Healthcare is recalling Revolution CT with Apex Edition CT System, distributed nationwide in the US. The recall was initiated on 23 Nov 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: 5995000-5; Serial Number's: REVVX1700078CN (System ID: 713MMREVCT/UDI: 01008406821185521117070021REVVX1700078CN) , 00000440315CN0 (System ID: 220078CT04), and REVVX1800040CN (System ID: M2322265/UDI: 01008406821185521118030021REVVX1800040CN).

Quantity recalled3 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-0695-2021
FDA event ID: 86932
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 23 Nov 2020
FDA classified: 22 Dec 2020
Reported: 30 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

23 Nov 2020	Recall initiated by company
22 Dec 2020	Classified by FDA	+29 days
30 Dec 2020	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

A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling

Product as listed by the FDA

Revolution CT with Apex Edition CT System - Product Usage: 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 and TX. The countries of Belgium, France, and Spain.

Nationwide Florida Texas

Questions about this recall

Is Revolution CT with Apex Edition CT System recalled?

Yes. GE Healthcare recalled Revolution CT with Apex Edition CT System on 23 Nov 2020. The recall is Class II and its status is Terminated. Recall number Z-0695-2021.

Why was it recalled?

A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling

Which lots are affected?

Model Number: 5995000-5; Serial Number's: REVVX1700078CN (System ID: 713MMREVCT/UDI: 01008406821185521117070021REVVX1700078CN) , 00000440315CN0 (System ID: 220078CT04), and REVVX1800040CN (System ID: M2322265/UDI: 01008406821185521118030021REVVX1800040CN).

Where was it sold?

Worldwide distribution - US Nationwide distribution including in the states of FL and TX. The countries of Belgium, France, and Spain.

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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