Device product
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Z-1324-2025
Product summary
- Event
- Event 96423
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1324-2025
Official wording
Reason: Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
Code information: Software Version Number 5.1.0; Model number: 728334; UDI-DI: (01)00884838103627(21)1005; Serial Number (SN): 1005;
Distribution pattern: Domestic: MN
Derived failure modes
-
Unknown
Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.