Device product
Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are 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. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Z-0791-2014
Product summary
- Event
- Event 66311
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23
- Official record key
device-enforcement:Z-0791-2014
Official wording
Reason: The DoseRight feature suggest a mAs based on the measured patient size, a reference size and a reference mAs. When scanning large children, the suggested mAs may be higher than clinicians would expect.
Code information: Brilliance iCT: Model Number 728311 and 728306, Serial Number: 100103, 100019, 100023, 100170, 200047, 200013 200005 and 100087. Brilliance 64: Model Number 728231 and 728326, Seial Number: 4003, 9745, 9875, 90135, 90169, 95414, 300003, 300004, 300005 and 300010. Brilliance CT Big Bore, Model Number: 728243, Serial Number: 7006, 7060, 7154, 7298 and 7349.
Distribution pattern: Worldwide Distribution - US Distribution including the states of DC, IL, IN, MI, MO, NY, OH, OR, PA, TX and VT., and the countries of Australia, Belgium, China, Germany, India, Israel, Italy and The Netherlands.
Derived failure modes
-
Unknown
The DoseRight feature suggest a mAs based on the measured patient size, a reference size and a reference mAs. When scanning large children, the suggested mAs may be higher than clinicians would expect.