Device product
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Z-1900-2021
Product summary
- Event
- Event 88116
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3665
- Official record key
device-enforcement:Z-1900-2021
Official wording
Reason: Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
Code information: Optima CT660 12HW28.8 14HW30.3 15HW25.2 13HW38.14 15HW13.7 Revolution EVO 14HW17.4 15HW13.7 Optima CT680 13HW38.14 15BW21.2
Distribution pattern: 3,665 (US = 956; OUS = 2,709)
Derived failure modes
-
Device software or design
software options may result in