Medtronic Physio-Control

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 11 건

  • 모델명 / 제조번호(시리얼번호)
    3202177-XXX
  • 제품 설명
    MD: Rechargeable public automated external defibrillator; Semi-automated external defibrillator
  • 모델명 / 제조번호(시리얼번호)
    3202359-XXX
  • 제품 설명
    MD: Rechargeable public automated external defibrillator; Semi-automated external defibrillator
  • 모델명 / 제조번호(시리얼번호)
    3202487-x, 3202488-x, U3202487-x, U3202488-x
  • 제품 설명
    MD: Defibrillation monitoring system
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    MD: Defibrillator, external, semi-automatic
  • 모델명 / 제조번호(시리얼번호)
    3202487-, U3202487-, U3202488-(various dash numbers)
  • 제품 설명
    MD: Defibrillator/monitor, pacemaker
하나 더 6 건 더

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 4 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 모회사 (2017)
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    BAM
  • 제조사 모회사 (2017)
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    SATP
  • Source
    ANVSANVISA
  • 제조사 모회사 (2017)
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HPRA