Worldwide Distribution- USA (nationwide) and Latin America.ġ A record in this database is created when a firm initiates a correction or removal action.
They will provide users and distributers with an amended "Technical Data" page for insertion int the user's manual.įurther questions please call (847) 459-3889. They will also provide users and distributers with corrected system labels to be placed on the x-ray control, beam limiting device, and tube housing assembly along with instructions for the proper application of these labels.
#Bluex xray for free#
Radiation Control for Health and Safety ActįONA will have upgraded copies of the manuals that will be made available on the firms website for free download and may also be mailed to each customer or end user should they request it. Also, the user's manual was found to have missing or improperly labeled information as required by. The IntraOs 70 system was found to have missing or incomplete system labels as required by. IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth. Unit, x-ray, intraoral - Product Code EAPįona Srl IntraOs 70 intra-oral x-ray system Class 2 Device Recall FONA Blue X Imaging Srl
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