Auriga XL 4007 Laser System

  • Modèle / numéro de série
    Serial Number: 20509715, 20465096, 20503137, 20520960, 20541967, 20546219, 20546440, 20575512, and 20575518.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    International Distribution Only -- Australia, Vietnam, France, Germany, Italy, Spain, and Romania.
  • Description du dispositif
    Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. || Intended to be used in surgical procedures.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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.”
  • Source
    USFDA

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  • Modèle / numéro de série
  • Manufacturer
    N/A
  • Modèle / numéro de série
    Auriga XL 4007 Laser SystemMaterial Number (UPN): M00684007GO Serial Numbers: 4007-A-076 and 4007-A-078 ARTG Number: 287772
  • Manufacturer
  • Modèle / numéro de série
    Auriga XL 4007 Laser SystemMaterial Number (UPN): M0068FS4007G0 Serial Numbers: 20546219 and 20575518 ARTG Number: 287772
  • Manufacturer