Device Recall Dimension Vista Intelligent Lab System

  • Modèle / numéro de série
    Siemens Material Number (SMN): 10284473, 10488224, 10444801, 10444802
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Austria, Australia, Belgium, Canada, Denmark, France, Finland, Germany, Japan, Italy, New Zealand, Netherlands, Czech Republic, Portugal, Republic Korea, Norway, Spain, Switzerland, Slovakia, Saudi Arabia, Slovenia, and United Kingdom,
  • Description du dispositif
    Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Société-mère du fabricant (2017)
  • Source
    USFDA

3 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Device Listing D011374 Serial Number: All serial numbers
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - United States Nationwide and Puerto Rico, Canada, Qatar, Republic Korea, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, United Kingdom, Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, and Portugal.
  • Description du dispositif
    Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical use || Product Usage: || The Siemens Healthcare Diagnostics Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use.
  • Manufacturer
  • Modèle / numéro de série
    Dimension Vista 500 Siemens material numbers: 10284473 (domestic), and 10488224 (international), Dimension Vista 1500 Siemens material numbers: 10444801 (domestic) and 10444802 (international).
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including PR and countries of: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic Korea, Saudia Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, and United Kingdom.
  • Description du dispositif
    Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. || In vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric, and integrated ion-selective multisensory technology for clinical use.
  • Manufacturer
  • Modèle / numéro de série
    Material Nos.: 10284473, 10488224,  10444801, and 10444802
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- Austria, Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic Korea, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, and United States.
  • Description du dispositif
    Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: || An in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
  • Manufacturer