Name: Defibrillator for Cardiac Resynchronization Therapy MRI. Technical Name: Implantable Defibrillator for Cardiac Resynchronization Therapy. ANVISA registration number: 10341350781. Class of risk: IV. Affected model: G150, G151, G156, G172, G173, G175, G177 .. Affected serial numbers: See attached list on the Anvisa portal - Link: http://portal.anvisa.gov.br/informacoes-tecnicas13?p_p_id = 101_INSTANCE_WvKKx2fhdjM2 & w; _p_col_id = column-2 & p; _p_col_pos = 1 & w; _p_col_count = 2 & _101_INSTANCE_WvKKx2fhdjM2_groupId = 33868 & _101_INSTANCE_WvKKx2fhdjM2_urlTitle = alert-2452-technical surveillance-Boston-defibrillator-to-therapy-to-resync-cardiac-mRI-problem-fault on-stimulation from the -biventricular cryptography & _101_INSTANCE_WvKKx2fhdjM2_struts_action =% 2Fasset_publisher% 2Fview_content & _101_INSTANCE_WvKKx2fhdjM2_assetEntryId = 3908895 & _101_INSTANCE_WvKKx2fhdjM2_type = content

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “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
    ANVSANVISA