Z-1301-2025Class II

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

Name: Z-1301-2025 GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed
Creator: GE Medical Systems, LLC
Published: 2025-02-18
License: https://open.fda.gov/license/

GE Healthcare / initiated 2025-02-18 / Open, Classified

FDA source

GE Medical Systems, LLC began a recall of GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed on 2025-02-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1301-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-18
Posted: 2025-03-07
Recalling firm: GE Healthcare
Product: GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed
Product code: JAK System, X-Ray, Tomography, Computed
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.
FDA root cause: Process change control
Action: GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/18/2025 via letter delivered using a traceable means. The notice explained the issue, safety issue, and requested the following actions be taken: "You can continue to use your system. Please monitor the floor near the base of the gantry for any accumulation of blue fluid. If blue fluid is observed, wear nitrile or rubber gloves, clean up the fluid by absorbing it with a noncombustible absorbent material, and dispose of the absorbent material in a suitable container for disposal. Please contact your local GE HealthCare service representative if any blue fluid is observed. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please complete and return the attached acknowledgement form to [email protected]."
Quantity in commerce: 1 unit
Distribution: Worldwide distribution.
Product codes and lots: System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1301-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1297-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-07
Z-1298-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-07
Z-1299-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-07
Z-1300-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-07
Z-1301-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-07
Z-1302-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-07
Z-1303-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-07

Product code JAK

K213715Class IIRevolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex editionGe Medical Systems, LLC / cleared 2021-12-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)