Reveal LINQ Insertable Cardiac Monitor

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
    SATP

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 8 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Model: LNQ11, Affected:
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    All Reveal LINQ ICM, Model LNQ11 serial numbers are impacted. Medtronic continues to manufacture and distribute Reveal Ll NQ devices.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) including DC and the countries of Andorra, Australia, Austria, Belgium, Botswana, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Faroe Islands , Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Namibia, Netherlands, New Caledonia, New Zealand, Norway, Oman, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania, Thailand, Turkey, United Arab Emirates and United Kingdom.
  • 제품 설명
    Reveal LINQ insertable Cardiac Monitor, Model LNQ11. || Monitors subcutaneous ECG continuously.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 이식된 장치?
    Yes
  • 제품 설명
    Active implantable medical devices - measuring devices and sensors
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: LNQ11 (Lot serial: All lots)
  • 제품 설명
    REVEAL LINQ INSERTABLE CARDIAC MONITOR
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
하나 더 3 건 더