Device Recall The Brilliance 64 and Ingenuity CT Computed Tomography Scanners

System Code # 728231, Serial #s: 91003, 95157, 9654, 95130, and 95504  System Code # 728326, Serial #s: 300010, 300030, and 300018

Radiology Devices

2

No

Worldwide Distribution - USA including IN and OH, also, the countries of Australia, Belgium, China, Israel, and Sweden

The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.