Device Recall CONTAK RENEWAL CRTDefibrillator

  • 모델명 / 제조번호(시리얼번호)
    RENEWAL (model H135) serial number range 100027 - 999983 includes CRT-Ds manufactured on or before August 26, 2004. These ranges include all affected devices but may include some unaffected devices.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    worldwide. Including the United States and countries such as: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czech Republic, Czechoslovakia, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Turkey, United Kingdom and Venezuela.
  • 제품 설명
    CONTAK RENEWAL (model H135) Heart Failure Device Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798. USA. Renewal provides ventricular tachyarrhythmia and cardiac resynchronization therapies.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA