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.
- Recall Initiated
- November 23, 2023
- Posted
- September 25, 2024
- Recall Number
- Z-3158-2024
- Quantity
- 130
- Firm Location
- Lexington, MA
Reason for Recall
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.
Distribution
US Nationwide and Worldwide
Lot / Code Info
All serial numbers shipped from FUJIFILM
Root Cause
Radiation Control for Health and Safety Act
Action Taken
Customer and Dealer notification will occur by means of letters alerting customers and dealers to the potential for overexposure to children if the conditions are not checked after the key switch is turned on. The notices also include the plan for the affected mobile x-ray systems. The system will be upgraded, free of charge, with updated software so that the exposure values set by the user are reflected regardless of the state of the key switch.