Mobile X-Ray System Exposure Settings May Not Apply Correctly
Fujifilm mobile x-ray systems may fail to apply configured exposure settings or default to adult chest imaging parameters. This could result in inappropriate radiation exposure levels.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device with potential for improper radiation exposure, classified as FDA Class II with no reported injuries or illnesses. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Fujifilm Healthcare Americas Corporation is recalling approximately 130 mobile x-ray systems from its FDR D-EVO2 family of digital x-ray detectors. These devices are distributed nationwide and worldwide.
When the key switch is turned on, the x-ray exposure conditions default to parameters intended for adult chest imaging: 85 kV, 1.6 mAs, and approximately 0.13 mGy at a 1-meter source-to-image distance. Additionally, if a technician configures exposure settings using the console while the key switch is off, those custom settings will not be reflected when the device is powered on. This means the system may deliver radiation exposure levels that are inappropriate for the patient being imaged or the body part being examined.
Healthcare facilities using these devices should verify that exposure settings are properly configured before each use. Fujifilm Healthcare Americas Corporation is providing guidance to customers. No injuries or illnesses have been reported related to this issue.
The recalled product
- Product
- 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.
- Manufacturer
- FUJIFILM Healthcare Americas Corporation
- Hazard
- radiation-exposure
- configuration-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers shipped from FUJIFILM
Distribution
Distributed nationwide across the United States.
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