FDA (Devices) recall action 89762
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
The agency’s own wording, quoted from the enforcement report.
GE Healthcare Revolution Apex and Revolution CT systems display accumulated radiation doses inaccurately high in certain situations. No injuries have been reported.
GE Healthcare Revolution CT scanners display inaccurate radiation dose values in certain situations. This could affect clinical dosing decisions during patient scans.