Device Recall AcusonX300

  • Modelo / Serial
    Sonovista: 10133170, Acuson: 10037409 (potentially affected but no volume: 10132987, 10038837). Software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including USA and countries of France, Colombia, Poland, Taiwan, Saudi Arabia, Austria, Malaysia, India, Czech Republic, Croatia, Argentina, Venezuela, Italy, Philippines, Mauritius, Spain, Bolivia, Germany, Ukrain, Russia, United Kingdom, Brazil, South Africa and Canada.
  • Descripción del producto
    Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02, manufactured by Siemens Ultrasound
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc., 1230 Shorebire Way, P.O. Box 7393, Mountain View CA 94043
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA