GE Medical Systems, LLC recalls GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed

Recall date

February 18, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1300-2025

FDA classification

Class II

Brand / firm

GE Medical Systems, LLC

Sold / distributed

Worldwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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