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.
FDA Recall Z-3158-2024 · Posted 2024-09-25
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Recalling FirmFUJIFILM Healthcare Americas Corporation
Recall StatusOpen, Classified
Product CodeIZL
Date Initiated2023-11-23
Product Quantity130
Reason for Recall
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.
Firm Action
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.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
US Nationwide and Worldwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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