Ellipse VR/DR

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    AFMPS

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데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
  • 이식된 장치?
    Yes
  • 제품 설명
    Active implantable medical devices - defibrillators
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: St. Jude Medical Ellipse VR/DR Implantable Cardioverter Defibrillators
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 이식된 장치?
    Yes
  • 제품 설명
    Active implant
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    CD1277, CD1377, CD2277, CD2377 (all -36, -36Q, -36C, -36QC) | All
  • 제품 설명
    AIMD: Implant, cardiac pacemaker
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    St. Jude Medical Ellipse VR/DR Implantable Cardioverter Defibrillators (ICDs)Models: CD1277 (-36 and -36Q) , CD1377 (-36, -36Q, -36C and -36QC), CD2277 (-36 and -36Q), CD2377 (-36, -36Q, -36C and -36QC) Serial Numbers: beginning with “1” that are below 1132470, beginning with the number “7” that are below 7126267 and all serial numbers beginning with an “8” are affected.ARTG Numbers: 207181, 207182, 207183, 207184, 207185, 207186, 207187, 207189, 202934, 202938, 198821, 198822
  • 의료기기 분류등급
  • Manufacturer
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