Device Recall TELIGEN Implantable Cardiac Defibrillator

  • 모델명 / 제조번호(시리얼번호)
    Model E102, serial numbers: 010347, 241131, 242141, 242171, 242431, 242505, 242543, 242657, 242708, 243839, 243965, 244071, 244521, 244580, 244921, 244928, 245000, 245295, 245479, 245519, 245578, 245583, 245619, 245655, 246303, 246369, 246384, 246395, 246396, 246481, 246498, 246502, 246508, 246511, 246516, 246542, 246546, 246548, 246558, 246561, 246592, 246609, 246618, 246653, 246752, 246756, 246888, 246959, 247313, 247342, 247346, 247417, 247452, 247481, 247614, 247618, 247632, 247663, 247687, 247779, 247788, 247893, 248102, 248353, 248557, 248587, 248622, 248630, 248635, 248670, 248805, 248916, 248933, 248968, 248997, 249064, 249083, 249087, 249130, 249370, 249398, 249454, 249468, 249496, 249533, 249534, 249537, 249538, 249556, 249594, 249602, 249627, 249629, 249631, 249650, 249669, 249727, 249751, 249753, 249777, 249868, 249882, 249925, 249934, 249943, 249954, 249960, 250007, 250020, 250031, 250049, 250067, 250089, 250114, 250120, 250121, 250135, 250139, 250147, 250159, 250191, 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254683, 254694, 254697, 254750, 254764, 254770, 254802, 254806, 254827, 254829, 254863, 254864, 254932, 254969, 254986, 255054.  Model E110, serial numbers: 111337, 112160, 116438, 116482, 116485, 117042, 117139, 118578, 119741, 120982, 121094, 121712, 121788, 121926, 121949, 122366, 122400, 122408, 122441, 122484, 122544, 122655, 122668, 122712, 122724, 122790, 122900, 123394, 123524, 123869, 123947, 124820, 124993, 125532, 125601, 125781, 125834, 126201, 126222, 126267, 126281, 126317, 126539, 126712, 126741, 126806, 126807, 126833, 126981, 127006, 127014, 127020, 127044, 127047, 127109, 127120, 127140, 127179, 127210, 127217, 127251, 127373, 127394, 127404, 127408, 127428, 127481, 127514, 127720, 127854, 127886, 127903, 127967, 128025, 128033, 128085, 128091, 128139, 128151, 128274, 128326, 128403, 128469, 128572, 129050, 129056, 129168, 129191, 129293, 129346, 129358, 129435, 129477, 129531, 129540, 129637, 129709, 129754, 129767, 129790, 129797, 129804, 129857, 129867, 129906, 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  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    nationwide within US only (OUS distribution not affected).
  • 제품 설명
    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator, Models E102 and E110. 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
  • 1 Event

제조사

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