Device Recall GE Healthcare Discovery MR450 1.5T

  • Modèle / numéro de série
    00000XRMBB0091 00000XRMBB0101 00000XRMBB0096 00000XRMBB0111 00000XRMBB0100 00000XRMBB0063 00000XRMBB0094 00000XRMBB0099 00000XRMBB0121 00000XRMBB0122 00000XRMBB0125
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, LA, MD, MA, MI, MO, NV, NJ, NY, NC, OR, PA, SC, TN, TX, WA, WI. and the countries of AUSTRALIA, BRAZIL, CANADA, EHYPT, FINLAND, FRANCE, GERMANY, GREECE, INDIA, ITALY, JAPAN, KUWAIT, QATAR, REPUBLIC OF KOREA, SWITZERLAND, TAIWAN, and the UNITED KINGDOM.UNITED KINGDOM, TAIWAN, SWITZERLAND, REPUBLIC OF KOREA, QATAR, KUWAIT, JAPAN, ITALY, INDIA, GREECE, GERMANY, FRANCE, FINLAND, EGYPT, CANADA, BRAZIL, AUSTRALIA.
  • Description du dispositif
    GE Healthcare Discovery MR450 1.5T, || The Discovery MR450 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used; The images produced by the Discovery MR450 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
  • Source
    USFDA