FDA Enforcement
Class II
Ongoing
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: Z-3158-2024
·
Reported October 2, 2024
Enforcement
- Recall Number
- Z-3158-2024
- Event ID
- 95320
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- FUJIFILM Healthcare Americas Corporation
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- October 2, 2024
- Initiation Date
- November 23, 2023
- Classification Date
- September 25, 2024
- Address
- 81 Hartwell Ave, Ste 300, Lexington, MA, 02421-3160, United States
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.
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 Info
All serial numbers shipped from FUJIFILM
Distribution
US Nationwide and Worldwide
Quantity
130