Device product
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Z-0306-2024
Product summary
- Event
- Event 93363
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0306-2024
Official wording
Reason: When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.
Code information: UDI-DI: 00884838103627; Lot Code: 1005
Distribution pattern: US Nationwide distribution in the state of MN.
Derived failure modes
-
Device software or design
software crash. This would result in