Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The device is a mobile x-ray system designed to work Recalled by FUJIFILM Healthcare Americas Corporation Due to When the key switch is turned on, the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact FUJIFILM Healthcare Americas Corporation directly.
Affected Products
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.
Quantity: 130
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About FUJIFILM Healthcare Americas Corporation
FUJIFILM Healthcare Americas Corporation has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report