Devices

Device Recall superDimension Bronchus System

  • Modelo / Serial
    All codes of disposable system components (Locatable Guide and Extended Working Channel).
  • Clasificación del producto
    Radiology Devices
  • 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
    SuperDimension, Inc.
  • 1 Event

Fabricante

SuperDimension, Inc.
  • Dirección del fabricante
    SuperDimension, Inc., 161 Cheshire Lane North, Suite 100, Minneapolis MN 55441
  • Source
    USFDA

Dispositivo con un nombre similar

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Device Recall superDimension Bronchus System
  • 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
    Radiology Devices
  • 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
    SuperDimension, Inc.