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U.S. Department of Health and Human Services

Class 2 Device Recall FDR AQRO (DRXD 1000)

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 Class 2 Device Recall FDR AQRO (DRXD 1000)see related information
Date Initiated by FirmNovember 23, 2023
Date PostedSeptember 25, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3158-2024
Recall Event ID 95320
510(K)NumberK170858 
Product Classification System, x-ray, mobile - Product Code IZL
ProductThe 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.
Code Information All serial numbers shipped from FUJIFILM
FEI Number 1000513161
Recalling Firm/
Manufacturer		 FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave
Ste 300
Lexington MA 02421-3160
For Additional Information ContactKotei Aoki
765-246-2931
Manufacturer 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.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionCustomer 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.
Quantity in Commerce130
DistributionUS Nationwide and Worldwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IZL
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