Device Recall Signa Excite 1.5 T (Excite II)

  • Modèle / numéro de série
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including DC and PR; and countries including: VIET NAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TURKEY, TUNISIA, FORMER YUGOSLAV REPUBLIC OF MACEDONIA, THAILAND, TAIWAN, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, REPUBLIC OF KOREA, PORTUGAL POLAND, PHILIPPINES, PERU,PARAGUAY, PANAMA, PAKISTAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MEXICO, MAURITIUS, MARTINIQUE,MALTA, MALAYSIA, LUXEMBOURG,LITHUANIA, LIBYAN ARAB JAMAHIRIYA, LEBANON, LATVIA, KUWAIT, KENYA, KAZAKHSTAN, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, ISLAMIC REPUBLIC OF IRAN, IRELAND, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, HONDURAS, GUYANA, GUATEMALA, GUADELOUPE, GREECE, GERMANY, GEORGIA, FRENCH POLYNESIA, FRANCE, FINLAND, EL SALVADOR, EGYPT, ECUADOR, DOMINICAN REPUBLIC, DENMARK, CECH REPUBLIC, CYPRUS, CROATIA, COLOMBIA, CHINA, CHILE, CANDA, BULGARIA, BRAZIL, BOSNIA AND HERZEGOVINA, BOLIVIA, BELGIUM, BELARUS, AZERBAIJAN, AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA.
  • Description du dispositif
    9) Signa Excite 1.5 T (Excite II) || (K013636 Signa Infinity MR System with EXCITE Technology) || Signa Infinity MR System with EXCITE || (K013636 Signa Infinity MR System with EXCITE Technology) || The GE Signa@ Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa@ Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs 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. The images produced by the Signa@ Infinity systems reflect the spatial distribution of protons (hydrogen 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