Device Recall Boston Scientific COGNIS

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- United States including Guam, Puerto Rico, and U.S. - Virgin Islands. OUS to include: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, China, Cocos (Keeling) Islands, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, Gabon, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Jordan, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, Tunisia, United Arab Emirates, United Kingdom and Venezuela.
  • 제품 설명
    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107, P108. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. || Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
  • Manufacturer
  • 2 Events

제조사

  • 제조사 주소
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-USA (nationwide) including Guam and Puerto Ricoand the countries of Argentina, Aruba, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, Hong Kong, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Gabon, Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Malaysia, Mexico, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Peru, Poland, Portugal, Saudi Arabia, Singapore, Si Lanka, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, UK, United Arab Republic, and Venezuela.
  • 제품 설명
    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. || Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model N118, Serial numbers: 559134, 559655, 560551, 561872, 561997, 562290, 562354, 562357, 563022, 563129, 564231, 564257, 564276 and 564489 and  Model N119, Serial numbers: 002009, 005588, 005947, 006015, 008336, 008383, 011748, 016012, 016410, 018621, 019026, 019284, 024632, 024670, 024705, 025094, 025446, 026128, 026211, 026713, 026935, 028047, 032967, 033881, 035717, 035791, 035824, 037277, 044056, 046565 and 046574.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    U.S. Distribution only (states of AZ, CA, CT, FL, GA, IA, IL, KY, MD, MO, NH, NJ, NY, OH, PA, SC, TN, TX, WI, and Washington D.C.) and Puerto Rico.
  • 제품 설명
    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N118 and N119. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA. || The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing.
  • Manufacturer