auriga xl 4007 laser system


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
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Más información acerca de la data acá

  • Modelo / Serial
  • Manufacturer
  • Modelo / Serial
    Serial Number: 20509715, 20465096, 20503137, 20520960, 20541967, 20546219, 20546440, 20575512, and 20575518.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    International Distribution Only -- Australia, Vietnam, France, Germany, Italy, Spain, and Romania.
  • Descripción del producto
    Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. || Intended to be used in surgical procedures.
  • Manufacturer
  • Modelo / Serial
    Auriga XL 4007 Laser SystemMaterial Number (UPN): M00684007GO Serial Numbers: 4007-A-076 and 4007-A-078 ARTG Number: 287772
  • Manufacturer
  • Modelo / Serial
    Auriga XL 4007 Laser SystemMaterial Number (UPN): M0068FS4007G0 Serial Numbers: 20546219 and 20575518 ARTG Number: 287772
  • Manufacturer