Device product
Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
Z-0242-2022
Product summary
- Event
- Event 89027
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 105 in total
- Official record key
device-enforcement:Z-0242-2022
Official wording
Reason: The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will show a value that is higher (up to 100 times) than the actual dose delivered.
Code information: Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
Distribution pattern: Worldwide and US Nationwide Distribution
Derived failure modes
-
Unknown
The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will show a value that is higher (up to 100 times) than the actual dose delivered.