The FUJIFILM digital mammography system is indicated for obtaining radiographic digital mammographic images by means of low doses of RX in the following procedures, but not limited to: screening mammograms: diagnostic tests for early detection of breast cancer in women who do not have symptoms. Diagnostic mammograms: revisions to assist in the diagnosis of mammary diseases and evaluation of abnormal clinical charts of screening mammograms in order to determine the cause of the controversial area in screening examination. Obtaining of digital mammographic images, their processing, recording and post-production of the mammographic images obtained with diagnostic purposes. Additionally, they can be used as a support for the stereotactic guide or for three coordinates for the placement of mammary gland biopsy needles after the mammography, noting that this equipment or its accessories do not contain biopsy needles, only give the coordinates for their placement and allow their application in the exact place chosen. by the doctor through the guide of the FUJIFILM digital mammography system.
“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.