Devices

Device Recall EOS

  • Model / Serial
    All Lots.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    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
    Sorin Group USA, Inc.
  • 1 Event

Manufacturer

Sorin Group USA, Inc.
  • Manufacturer Address
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    USFDA

6 devices with a similar name

Learn more about the data here

Device Recall EOS system
  • Model / Serial
    Model Number - EOS System
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of: CA, DE, PA, MN, FL, MO, OH, IN and IL.
  • Product Description
    EOS, Digital radiography system used in general radiographic examinations.
  • Manufacturer
    Eos Imaging Inc
Device Recall EOS System
  • Model / Serial
    All associated Serial Numbers
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution
  • Product Description
    EOS X-ray Medical Diagnostic , X-ray Equipment System || Digital Radiography used in general radiographic examination.
  • Manufacturer
    Eos Imaging Inc
Device Recall EOS System X ray beam
  • Model / Serial
    EOS System
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    EOS System X- ray beam || Digital radiography system used in general radiographic examinations.
  • Manufacturer
    EOS Imaging
Device Recall EOS Imaging
  • Model / Serial
    Software versions: 1.3, 1.4 and 1.5
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution
  • Product Description
    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
    EOS Imaging
Device Recall Eosin stain
  • Model / Serial
    Lot numbers: 102560, 102996, 103493, 103840, 104594 and 105052.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    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
    Wescor, Inc
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