Device Recall ClearSight System

  • Modelo / Serial
    All serial numbers. From 600104000221 to 600104005025
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Estonia, Italy, Romania, Sweden, Austria, Finland, Kuwait, Saudi Arabia, Switzerland, Bahrain, France, Netherlands, Slovenia, Turkey, Belgium, Great Britain, Oman, Slovakia, South Africa, Bulgaria, Greece, Poland, South Africa, United Arab Emirates, Czech Republic, Hungary, Portugal, Spain, Denmark, Ireland, and Qatar.
  • Descripción del producto
    ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Edwards Lifesciences, LLC, 1 Edwards Way, Irvine CA 92614-5688
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA