Device Recall Brilliance Big Bore CT system

Model #728243, Serial Numbers: 7006, 7154, and 7349.

Radiology Devices

2

No

Worldwide Distribution - Nationwide (USA) including the states of: IN, MI, MO, NY, OH, and OR and the countries of Germany, Israel and Netherlands.

Brilliance Big Bore CT (Computed Tomography) System, 510 (k) #K033357, Model #728243, Serial Numbers: 7006, 7154, and 7349. The recalled CT systems are equipped with Software Version 3.5 Beta 2. || Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.