CLASS II ONGOING Device recall · Reported 19 Mar 2025 · FDA Enforcement Report

GE Healthcare Revolution Apex Select, System, X-ray recalled

GE Medical Systems is recalling GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed. The recall was initiated on 18 Feb 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSystem ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN

Quantity recalled1 unit

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-1301-2025
FDA event ID: 96370
Recalling firm: GE Medical Systems, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 18 Feb 2025
FDA classified: 7 Mar 2025
Reported: 19 Mar 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Imaging Equipment

Timeline

18 Feb 2025	Recall initiated by company
7 Mar 2025	Classified by FDA	+17 days
19 Mar 2025	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 issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

Which lots are affected?

System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN

Where was it sold?

Worldwide 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

6 other products · FDA event 96370

This product is part of a recall event; the main page for the event is GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed recalled.

Reported	Class	Recall	Company	Reason	Where
19 Mar 2025	CLASS II	GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed recalled	GE Medical Systems	Packaging Defects	WI
19 Mar 2025	CLASS II	GE Healthcare Revolution CT, System, X-ray, Tomography, Computed recalled	GE Medical Systems	Packaging Defects	WI
19 Mar 2025	CLASS II	GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed recalled	GE Medical Systems	Packaging Defects	WI
19 Mar 2025	CLASS II	GE Healthcare Revolution Apex Expert, System, X-ray recalled	GE Medical Systems	Packaging Defects	WI
19 Mar 2025	CLASS II	GE Healthcare Revolution Apex Plus, System, X-ray recalled	GE Medical Systems	Packaging Defects	WI
19 Mar 2025	CLASS II	GE Healthcare Revolution Apex Elite, System, X-ray recalled	GE Medical Systems	Packaging Defects	WI

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