Device Recall Signa Ovation

  • Modèle / numéro de série
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  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, LA, KS, KY, LA, MD, MA, MI, MN, MS,MO,MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WV, and WI and countries of VENEZUELA, ECUADOR, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, SPAIN, RUSSIAN FEDERATION, REPUBLIC OF KOREA, POLAND, PHILIPPINE,S OMAN, MEXICO, KUWAIT, JAPAN, ITALY, HUNGARY, GERMANY, EGYPT, DENMARK, CHILE, CHINA, and BRASIL.
  • Description du dispositif
    Signa Ovation, 0.35T MR Systems (MFO 1-4). || Indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the musculoskeletal, vascular, cardiac, and neuro systems.
  • 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