Device Recall CONTAK RENEWAL 4 AVT

  • 모델명 / 제조번호(시리얼번호)
    Model M170, serial numbers: 100136, 100138, 100142, 100144, 100145, 200003, 200004, 200006, 200007, 200009, 200010, 200011, 200013, 200017, 200018, 200019, 200021, 200022, 200023, 200025, 200027, 200028, 200029, 200030, 200032, 200033, 200034, 200035, 200036, 200037, 200038, 200039, 200041, 200042, 200043, 200046, 200047, 200048, 200051, 200052, 200053, 200054, 200056, 200057, 200058, 200059, 200060, 200073, 200074, 200077, 200079, 200082, 200084, 200087, 200088, 200089, 200090, 200093, 200094, 200095, 200098, 200101, 200112.  Model M175, serial numbers: 100202, 100207, 100209, 100210, 100211, 100212, 100213, 100214, 100215, 100216, 100219, 100221, 100222, 100224, 100251, 100277, 100282, 100283, 100284, 100298, 100299, 100336, 100341, 100344, 100345, 100349, 100350, 100353, 100354, 100356, 100358, 100361, 100362, 100369, 100370, 100372, 100384, 100401, 100404, 100407, 100409, 100410, 100411, 100418, 100421, 100433, 200002, 200003, 200004, 200005, 200007, 200009, 200010, 200011, 200012, 200014, 200015, 200016, 200017, 200019, 200022, 200025, 200027, 200028, 200029, 200030, 200032, 200033, 200034, 200036, 200038, 200039, 200040, 200042, 200044, 200047, 200048, 200051, 200052, 200053, 200054, 200056, 200057, 200058, 200060, 200062, 200067, 200071, 200074, 200075, 200079, 200080, 200081, 200083, 200084, 200085, 200086, 200088, 200089, 200091, 200092, 200093, 200094, 200095, 200108, 200112, 200113, 200115, 200124, 200143, 200153, 200156, 200157, 200158, 200162, 200163, 200166.  Model M177, serial numbers: 100154, 100157, 100158, 100168, 100169, 100173, 100174, 100180, 100181, 100182, 100183, 100190, 100191, 100196, 100197, 100221, 200003, 200004, 200005, 200006, 200007, 200008, 200009, 200010, 200011, 200012, 200013, 200014, 200015, 200016, 200017, 200018, 200020, 200021, 200022, 200023, 200024, 200025, 200026, 200027, 200028, 200029, 200030, 200032, 200033, 200034, 200035, 200036, 200037, 200038, 200039, 200040, 200041, 200042, 200044, 200045, 200046, 200047, 200048, 200049, 200052, 200053, 200054, 200055, 200056, 200057, 200058, 200059, 200060, 200062, 200066, 200067, 200068, 200069, 200072, 200073, 200074, 200076, 200078, 200080, 200081, 200083, 200084, 200085, 200086, 200087, 200089, 200090, 200091, 200092, 200093, 200095, 200096, 200097, 200099, 200102, 200104, 200105, 200106, 200107, 200108, 200109, 200110, 200111, 200112, 200113, 200114, 200115, 200116, 200117, 200118, 200119, 200120, 200121, 200122, 200123, 200124, 200125, 200126, 200128, 200129, 200130, 200131, 200134, 200135, 200136, 200140, 200141, 200142, 200143, 200145, 200146, 200147, 200148, 200149, 200150, 200152, 200153, 200154, 200155, 200156, 200158, 200160, 200161, 200164, 200165, 200166, 200167, 200168, 200169, 200170, 200171, 200172, 200175, 200177, 200178, 200179, 200180, 200181, 200182.  Model M179, serial numbers: 100216, 100217, 100219, 100223, 100227, 100228, 100229, 100230, 100231, 100232, 100233, 100235, 100237, 100238, 100239, 100240, 100243, 100244, 100247, 100250, 100253, 100256, 100257, 100263, 100266, 100270, 100271, 100272, 100274, 100275, 100276, 100278, 100279, 100280, 100281, 100282, 100283, 100285, 100287, 100290, 100291, 100293, 100294, 100295, 100297, 100298, 100300, 100302, 100303, 100304, 100305, 100315, 100316, 100317, 100319, 100321, 100322, 100323, 100324, 100325, 100326, 100327, 100338, 100342, 100343, 100349, 100353, 100354, 100391, 100430, 100435, 100436, 100437, 100439, 100440, 100441, 100442, 100448, 100449, 100450, 100452, 100467, 100469, 100470, 100473, 100475, 100479, 100480, 100482, 100488, 100489, 100500, 100502, 100503, 100515, 100516, 100517, 100520, 100522, 100533, 100543, 100545, 100547, 100549, 100552, 100555, 100556, 100557, 100558, 100563, 100566, 100567, 100568, 100577, 100579, 100581, 100584, 100587, 100589, 100590, 100591, 100614, 200002, 200003, 200004, 200005, 200006, 200007, 200008, 200009, 200010, 200013, 200014, 200015, 200016, 200017, 200018, 200019, 200020, 200021, 200022, 200023, 200024, 200026, 200027, 200028, 200029, 200030, 200031, 200032, 200035, 200036, 200037, 200039, 200040, 200042, 200043, 200044, 200046, 200047, 200049, 200051, 200052, 200053, 200054, 200055, 200056, 200058, 200059, 200060, 200061, 200062, 200063, 200064, 200065, 200066, 200068, 200070, 200071, 200072, 200075, 200077, 200078, 200079, 200080, 200081, 200083, 200084, 200086, 200088, 200089, 200090, 200092, 200093, 200094, 200096, 200097, 200100, 200101.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide, including USA, Argentina, Aruba, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Canada, Chile, Costa Rica, Cyprus, Czech Republic, Czechoslovakia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guam, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Polynesia, Portugal, Puerto Rico, Qatar, Saint Lucia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Tunisia, Turkey, U.S. Virgin Islands, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, and West Indies.
  • 제품 설명
    These models are not available in the US. CONTACT RENEWAL 4 AVT HE (model number M170, M175, M177, M179). Cardiac Resynchronization Therapy Defibrillator. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
  • Manufacturer
  • 1 Event

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 1 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    all serial numers
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    worldwide. Including United States, Virgin Islands and countries such as Argentina, Australia, Austria, Barbados, Belgium, Bermuda, Canada, Cayman Islands, Chile, Colombia, Cyprus, Czech Republic, Denmark, Eygpt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Labanon, Luxembourg, Marshall Islands, Mexico, Netherlands, New Zealand, Northern Mariana Islands, Norway, Peru, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom and Venezuela.
  • 제품 설명
    CONTAK RENEWAL 4 AVT CRT-D (model no. M170 and M175) and CONTAK RENEWAL 4 AVT HE CRT-D (model no. M177 and M179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, 4100 Hamiline Avenue North, St. Paul, MN 55112-5798 USA. CONTAK RENEWAL 4 AVT devices provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies.
  • Manufacturer