Device product
The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
Z-3158-2024
Product summary
- Event
- Event 95320
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 130
- Official record key
device-enforcement:Z-3158-2024
Official wording
Reason: When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the set exposure conditions will not be reflected.
Code information: All serial numbers shipped from FUJIFILM
Distribution pattern: US Nationwide and Worldwide
Derived failure modes
-
Unknown
When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the set exposure conditions will not be reflected.