FDA recall Z-1302-2025

GE Medical Systems, LLC · Class II · device

Product

GE Healthcare Revolution CT, 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.

Distribution

Worldwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-02-18
Report date
2025-03-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1302-2025