Covidien Ltd.

  • 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.
  • 제조사 대표
    FAROUK, MAAMOUN TAMER & COMPANY, Riyadh, (01) 4142200
  • Source
    SFDA
  • 1 Event

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 1 건

  • 모델명 / 제조번호(시리얼번호)
    Surgical Stapler, ROTICULATOR™ Single Use Stapler Ref# Product description 017612 ROTICULATOR™ 55-3.5 Single Use Stapler 017614 ROTICULATOR™ 55-4.8 Single Use Stapler 017615 ROTICULATOR™ 30-3.5 Single Use Stapler 017617 ROTICULATOR™ 30-4.8 Single Use Stapler 017619 ROTICULATOR™ 30-V3 Single Use Stapler Any Lot # starts with the following must be retrained: P7E, P7F, P7G, P7H, P7J, P7K, P7L, P7M, P8A, P8B, P8C, P8D, P8E , P8F, P8G, P8H, P8J, P8K, P8L, P8M, P9A, P9B, P9C, P9D, P9E , P9F, P9G, P9H, P9J, P9K, P9L, P9M, P0A, P0B, P0C, P0D, P0E , P0F, P0G, P0H, P0J, P0K, P0L, P0M, P1A, P1B, P1C, P1D, P1E , P1F, P1G, P1H, P1J, P1K, P1L, P1M, P2A, P2B0153X
  • 제품 설명
    Surgical, Single Use Stapler