Single Chamber Temporary External Pacemaker 53401

제조사

  • 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
    DH

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데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Affected devices include Model 53401 EPGs with serial numbers lower than MDB05000 that were distributed between February 2017 and November 2017.
  • 제품 설명
    Pacemaker, cardiac, external, invasive
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Single Chamber Temporary External Pacemaker 53401, Medtronic Inc
  • Manufacturer