FDAFDA · Food and drugs·Recall number Z-3158-2024
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.
Published October 2, 2024 · Recall initiated: November 23, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- FUJIFILM Healthcare Americas Corporation
- Distributor
- US Nationwide and Worldwide
- Lot
- All serial numbers shipped from FUJIFILM
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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