“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.
Discovery MR750, Optima MR450w with the GEM option, Discovery MR750w with the GEM option. Software version DV25
Description du dispositif
It uses an imaging technique that uses the magnetic properties of the atomic nuclei of the material (tissues, organs, bones, etc.). This signal that reflects the atoms is captured and translated into very precise images, which reveal a number of normal and abnormal anatomical situations that a trained professional can interpret for the diagnosis of different pathologies.
It uses a diagnostic imaging technique that uses the magnetic properties of the atomic nuclei of matter (tissues, organs, bones, etc.). This signal reflected by the atoms is captured and translated into very precise images, which reveal a number of normal and abnormal anatomical situations that a trained professional can interpret for the diagnosis of diverse pathologies.
Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, Discovery MR750w equipped with the GEM option
Description du dispositif
It uses an imaging technique that uses the magnetic properties of the atomic nuclei of the material (tissues, organs, bones, etc.). This signal that reflects the atoms is captured and translated into very precise images, which reveal a number of normal and abnormal anatomical situations that a trained professional can interpret for the diagnosis of different pathologies.
The intended use of PHILIPS MRI medical electromedical systems is class IIa diagnostic equipment. The systems can generate transverse and spectroscopic images in any orientation of the internal structure of the head, body or extremities. Magnetic resonance images represent the spatial distribution of protons or other nuclei with spin. The appearance of the images is determined by different physical properties of tissue and anatomy, and the technique of acquisition by applied MRI. The image acquisition process can be synchronized with the patient's breathing or with the cardiac cycle. The systems can use combinations of images to generate physical parameters and related derived images. The images, the spectra, and the measurements of physical parameters, after being interpreted by the medical specialist, provide information that can facilitate the diagnosis and planning of the therapy. The accuracy of certain physical parameters depends on the system and the acquisition parameters, and must be regulated and validated by the clinical user. For some studies, the use of contrast media may be essential. During an MRI exam, energy is transferred to the patient in the form of radio frequency waves, changing magnetic fields and acoustic noise. The PHILIPS magnetic resonance systems do not emit radiation-ionizing agents. Non-invasive diagnostic equipment