Device Recall Echelon and Oasis

  • Modelo / Serial
    Echelon, V001 through V061, inclusive. Oasis, M001 through M105, inclusive, M951
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution - including the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and Mexico.
  • Descripción del producto
    Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. || Product Usage: || The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis determination.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA