medical Class II Updated 2024-10-02

FUJIFILM Healthcare Americas Corporation recalls The device is a mobile x-ray system designed to work with Fu

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All serial numbers shipped from FUJIFILM
View official government recall

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