Device product
Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Z-1951-2019
Product summary
- Event
- Event 83254
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 857 (US = 195: OUS = 662)
- Official record key
device-enforcement:Z-1951-2019
Official wording
Reason: Additional low dose radiation exposure.
Code information: Revolution CT
Distribution pattern: Worldwide - US Nationwide Distribution
Derived failure modes
-
Unknown
Additional low dose radiation exposure.