Class II

Medical Device Recall: GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed

GE Medical Systems, LLC · February 18, 2025

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.

Distribution

Worldwide distribution.

Quantity Affected

250 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1298-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

GE Medical Systems, LLC Medical Device Recall: GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed | SafeCheck