FDA (Devices) recall action 96370
The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
GE Healthcare Revolution Apex and Revolution CT series systems may leak coolant fluid onto the floor near the gantry. The blue-colored, non-toxic fluid poses a slip and fall hazard if not noticed.
GE Healthcare Revolution CT and Apex series systems can leak coolant fluid onto the floor near the gantry, creating a slip and fall hazard. The blue-colored fluid is non-corrosive and not hot, but poses injury risk if not noticed.
GE Healthcare is recalling 21 Revolution CT and Revolution Apex series CT systems due to potential coolant fluid leaks near the gantry base. The leaking fluid poses a slip-and-fall hazard if not cleaned up promptly.
GE Healthcare is recalling Revolution CT and Revolution Apex series systems due to potential coolant fluid leaks from the gantry base, which could create a slip and fall hazard.
Certain GE Healthcare Revolution CT and Apex series systems may leak coolant fluid near the gantry base, creating a potential slip-fall hazard if left unnoticed.
GE Healthcare Revolution CT and Apex series imaging systems may leak blue coolant fluid near the gantry base, creating a potential slip and fall hazard. Approximately 250 units have been distributed worldwide.
GE Healthcare Revolution CT systems may leak glycol coolant near the gantry base. While the non-toxic fluid poses no chemical hazard, it creates a slip-and-fall risk if not noticed and cleaned.