Device Recall EOS

  • Modelo / Serial
    All Lots.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    D 905 EOS Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy. || Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

6 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Model Number - EOS System
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of: CA, DE, PA, MN, FL, MO, OH, IN and IL.
  • Descripción del producto
    EOS, Digital radiography system used in general radiographic examinations.
  • Manufacturer
  • Modelo / Serial
    All associated Serial Numbers
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution
  • Descripción del producto
    EOS X-ray Medical Diagnostic , X-ray Equipment System || Digital Radiography used in general radiographic examination.
  • Manufacturer
  • Modelo / Serial
    EOS System
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    EOS System X- ray beam || Digital radiography system used in general radiographic examinations.
  • Manufacturer
  • Modelo / Serial
    Software versions: 1.3, 1.4 and 1.5
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution
  • Descripción del producto
    steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images || Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
  • Manufacturer
  • Modelo / Serial
    Lot numbers: 102560, 102996, 103493, 103840, 104594 and 105052.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide, Foreign distribution to Algeria, Australia, Austria, Canada, Cyprus, Denmark, France, Germany, Hungary, Ireland, Italy, Japan, Kuwait, Malta, Netherlands, Oman, Panama, Poland, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, United Arab Emirates, UK, and Venezuela.
  • Descripción del producto
    SS-035CG, Hematology Reagent C Eosin Stain, 1 U.S. Gallon, IVD, Wescor, Inc, Logan, Utah 84321. || Specifically for use on the Wescor 7120 Hematology Aerospray Slide Stainer and is intended for use by medical professionals to stain specimens that may include blood and other body fluids as a step of standard laboratory practice in diagnosing disease in humans.
  • Manufacturer
Uno más