Device product
Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: 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-1396-2018
Product summary
- Event
- Event 79759
- Status
- Terminated
- Classification
- Class II
- Quantity
- 291
- Official record key
device-enforcement:Z-1396-2018
Official wording
Reason: Surview scan with tube current lower than 30 mA is unable to be initialized.
Code information: Serial numbers: . 9134 9667 9738 9788 9923 10773 95263 95669
Distribution pattern: Worldwide Distribution - US Nationwide in the states of GA, VA, MI, AZ, and the countries of Canada, Switzerland
Derived failure modes
-
Unknown
Surview scan with tube current lower than 30 mA is unable to be initialized.