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
- Recall Number
- Z-3158-2024
- Event Number
- 95320
- Firm
- FUJIFILM Healthcare Americas Corporation
- FEI Number
- 1000513161
- Product Code
- IZL
- Status
- Open, Classified
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- November 23, 2023
- Posted
- September 25, 2024
- Address
- 81 Hartwell Ave, Ste 300, Lexington, MA, 02421-3160
Description
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.
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.
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.
US Nationwide and Worldwide
130