Cardioverter Defibrillator

Fabricante

  • 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.”
  • Representante del fabricante
    Medilife s.a.l
  • Source
    RLMPH

78 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Viva Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) and Evera Implantable Cardioverter Defibrillator (ICDs)Affected devices implanted in Australia:Evera XT VR ICD Model: DVBB2D4Serial numbers: BWJ601108S, BWJ601112S, BWJ601479S ARTG number: 208027
  • Clasificación del producto
  • Manufacturer
  • Modelo / Serial
    Ovatio, Paradym, Paradym RF and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)Ovatio - CRT 6750, DR 6550, VR 6250Previous ARTG #: 132650, 132586, 132649 Paradym - VR 8250, DR 8550, CRT-D 8750ARTG #: 170105, 170104, 163470,Paradym RF - VR 9250, DR 9550, CRT-D 975, SonR 9770 ARTG #: 197571, 197572, 197573, 197574Intensia - VR 124, DR 154, CRT-D 174, SonR CRT-D 184ARTG #: 230583, 230582, 230580, 230581
  • Manufacturer
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