FDA-Device2025-03-19Class II
GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed
GE Medical Systems, LLC
Hazard
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.
Sold states
Worldwide distribution.
Affected count
1 unit
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1301-2025Don't want to check this manually?
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