Device product
Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP 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.
Z-0832-2014
Product summary
- Event
- Event 67306
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 units
- Official record key
device-enforcement:Z-0832-2014
Official wording
Reason: Patient images exhibited ring artifacts.
Code information: Brilliance iCT: 728306, Serial #'s: 100018, 100040, 100411, 100503, 100506 Brilliance iCT SP: 728311, Serial #'s: 200047, 200121
Distribution pattern: Worldwide Distribution: US (nationwide) including states of: FL, IN, NY, OR and PA; and internationally to: Australia and Israel.
Derived failure modes
-
Unknown
Patient images exhibited ring artifacts.