Device Recall EOS

  • Modèle / numéro de série
    All Lots.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
  • Société-mère du fabricant (2017)
  • Source
    USFDA

6 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Model Number - EOS System
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of: CA, DE, PA, MN, FL, MO, OH, IN and IL.
  • Description du dispositif
    EOS, Digital radiography system used in general radiographic examinations.
  • Manufacturer
  • Modèle / numéro de série
    All associated Serial Numbers
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution
  • Description du dispositif
    EOS X-ray Medical Diagnostic , X-ray Equipment System || Digital Radiography used in general radiographic examination.
  • Manufacturer
  • Modèle / numéro de série
    EOS System
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    EOS System X- ray beam || Digital radiography system used in general radiographic examinations.
  • Manufacturer
  • Modèle / numéro de série
    Software versions: 1.3, 1.4 and 1.5
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution
  • Description du dispositif
    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
  • Modèle / numéro de série
    Lot numbers: 102560, 102996, 103493, 103840, 104594 and 105052.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
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