superDimension Bronchus System

Fabricante

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DMA

5 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    superDimension Bronchus System with the following serial numbers: S0030019, S030051, S030052, S030054, S030055, S030058 thru S030062, S030067, S030068, S030077 thru S030081; S030084, S030085, S030088 thru S030095; S030097 thru S030100, S030103, S030104, S030105, S030390, S030447, S030449, S0030009, S0030011, S0030013, S0030014, S0030015, S0030021, S0030022, S0030026, S0030042, S030043 thru S030050, S030053, S030056, S030057, S030063, S030064, S030066, S030069 thru S030076, S030082, S030086, S030087, S030096, S030102, S030477.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide, including USA, Austria, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, South Africa, Spain, Switzerland, Turkey, and United Kingdom.
  • Descripción del producto
    superDimension Bronchus System (AAS00016-01), an image-guided localization system used to guide endoscopic tools to predetermined targets within the pulmonary tract.
  • Manufacturer
  • Modelo / Serial
    All codes of disposable system components (Locatable Guide and Extended Working Channel).
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide, including USA, Austria, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, South Africa, Spain, Switzerland, Turkey, and United Kingdom.
  • Descripción del producto
    Disposable components of the superDimension Bronchus System: Locatable Guide Kit (AKI00017-01) and Extended Working Channel (AKI00041-01).
  • Manufacturer
  • Modelo / Serial
  • Descripción del producto
    Optics / Precision engineering
  • Manufacturer
  • Modelo / Serial
    AAS00016-01, AKI00017-01, AKI00041-01 | all devices
  • Descripción del producto
    MD: Bronchoscope
  • Manufacturer
  • Modelo / Serial
    AAS00016-xx | see FSN | 4.0 - 4.9
  • Descripción del producto
    MD: Flexible video bronchoscope
  • Manufacturer