Device Recall Cardiovive 92532 automated external defibrillator

  • 모델명 / 제조번호(시리얼번호)
    SERIAL NUMBERS: 4022185, 92532-0001124, 4022096, 4022095, 4022094, 4022093, 4022092, 4022091, 4022089, 4022088, 4022087, 4022086, 4022085, 4022084, 4022233, 4022234, 4022235, 4022236, 4022090, 4022112, 4022126, 4022125, 4022124, 4022123, 4022122, 4022121, 4022120, 4022119, 4022118, 4022117, 4022116, 4022115, 4022099, 4022113, 4022098, 4022111, 4022110, 4022109, 4022108, 4022107, 4022106, 4022105, 4022104, 4022103, 4022102, 4022101, 4022250, 4022100, 4022114, 4022268, 4022248, 4022278, 4022277, 4022276, 4022275, 4022274, 4022273, 4022272, 4022271, 4022280, 4022269, 4022258, 4022267, 4022266, 4022265, 4022264, 4022263, 4022262, 4022261, 4022260, 4022127, 4022203, 4022270, 4022251, 4022238, 4022239, 4022240, 4022241, 4022242, 4022243, 4022244, 4022245, 4022246, 4022279, 4022249, 4022237, 4022252, 4022253, 4022254, 4022255, 4022256, 4022259, 4022283, 4022282, 4022257, 4022281, 4022247, 4022190, 4022206, 4022232, 4022205, 4022204, 4022200, 4022198, 4022197, 4022196, 4022195, 4022128, 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4171137, 4171136, 4171143, 4171134, 4171144, 4171132, 4171131, 4171130, 4171129, 4171128, 4171127, 4171126, 4171135, 4171152, 4171159, 4171158, 4171157, 4171156, 4171064, 4171155, 4171198, 4171142, 4171153, 4171125, 4171151, 4171150, 4171149, 4171148, 4171147, 4171146, 4171145, 4171154, 4170989, 4170982, 4170983, 4170984, 4170985, 4170986, 4170965, 4170988, 4170980, 4170990, 4170992, 4170993, 4170994, 4170995, 4170996, 4170987, 4170974, 4170966, 4170967, 4170968, 4170969, 4170970, 4170971, 4171063, 4170973, 4170981, 4170975, 4170976, 4170977, 4170978, 4170979, 4171000, 4170972, 4170931, 4170997, 4171020, 4171021, 4171022, 4171023, 4171024, 4171018, 4171026, 4171017, 4170930, 4170929, 4170928, 4170927, 4170926, 4170933, 4171025, 4171008, 4171010, 4171001, 4171002, 4171003, 4171004, 4171005, 4171019, 4171007, 4170999, 4171009, 4171011, 4171013, 4171014, 4171015, 4171016, 4171006, 4171037, 4171030, 4171044, 4171043, 4171042, 4171041, 4171040, 4171046, 4171038, 4171047, 4171036, 4171035, 4171034, 4171033, 4171032, 4171031, 4171039, 4171056, 4171062, 4171012, 4170964, 4171061, 4171060, 4171059, 4171045, 4171057, 4171049, 4171055, 4171054, 4171053, 4171052, 4171050, 4171048, 4171058, 4170958, 4170948, 4170949, 4170950, 4170951, 4170952, 4170953, 4170947, 4170957, 4170955, 4170959, 4170960, 4171029, 4171051, 4170961, 4170962, 4170963, 4170956, 4170934, 4170936, 4171028, 4170935, 4170946, 4170937, 4170939, 4171027, 4170940, 4170945, 4170944, 4170942, 4170943, 4170941, 4170938, 4130935, 4130934, 4130933, 4130932, 4130931, 4130930, 4130936, 4130928, 4130940, 4130927, 4130929, 4130948, 4130937, 4130944, 4130939, 4130942, 4130947, 4130943, 4130946, 4130945, 4130926, 4130938, 4130913, 4130907, 4122652, 4131000, 4130949, 4122651, 4122649, 4122648, 4130908, 4130909, 4130910, 4122650, 4130912, 4130925, 4130914, 4130915, 4130916, 4130917, 4130918, 4130919, 4130920, 4130921, 4130922, 4130923, 4130924, 4130911, 4130992, 4130979, 4130980, 4130981, 4130982, 4130983, 4130984, 4130985, 4130987, 4130988, 4130989, 4130998, 4130991, 4130976, 4130993, 4130994, 4130995, 4130996, 4130997, 4130999, 4131001, 4131002, 4122653, 4130902, 4130990, 4130963, 4130951, 4130952, 4130953, 4130954, 4130955, 4130956, 4130957, 4130958, 4130959, 4130960, 4130978, 4130962, 4130977, 4130964, 4130965, 4130966, 4130967, 4130968, 4130969, 4130972, 4130973, 4130974, 4130975, 4130950, 4130961, 4122715, 4122727, 4122726, 4122725, 4122724, 4122723, 4122722, 4122721, 4122720, 4122719, 4122718, 4130904, 4122716, 4122730, 4122714, 4122713, 4122712, 4122711, 4122710, 4122709, 4122708, 4122707, 4122706, 4122746, 4122717, 4122741, 4130897, 4130898, 4130899, 4130900, 4130901, 4122647, 4130903, 4131003, 4122745, 4122744, 4122728, 4122742, 4122729, 4122740, 4122739, 4122738, 4122737, 4122736, 4122735, 4122734, 4122733, 4122732, 4122731, 4122704, 4122743, 4122664, 4122677, 4122676, 4122675, 4122674, 4122673, 4122672, 4122671, 4122669, 4122668, 4122667, 4122705, 4122665, 4122680, 4122663, 4122662, 4122661, 4122660, 4122659, 4122658, 4122657, 4122656, 4122655, 4130906, 4122666, 4122691, 4122703, 4122702, 4122701, 4122700, 4122699, 4122698, 4122697, 4122696, 4122695, 4122694, 4122678, 4122692, 4122679, 4122690, 4122689, 4122688, 4122687, 4122686, 4122685, 4130905, 4122683, 4122682, 4122681, 4122654, 4122693, 4131040, 4131024, 4131025, 4131026, 4131027, 4131028, 4131029, 4131031, 4131032, 4131033, 4131023, 4131039, 4131030, 4131041, 4131042, 4131044, 4131045, 4131046, 4131037, 4131036, 4131038, 4131035, 4131034, 4131004, 4131006, 4131007, 4131009, 4131022, 4131010, 4131005, 4131011, 4131012, 4131013, 4131014, 4131019, 4131008, 4131015, 4131021, 4131020, 4131018, 4131017, 4131016, 4105913, 4105909, 4105910, 4105911, 4105935, 4105912, 4105908, 4105928, 4105942, 4105941, 4105940, 4105939, 4105938, 4105937, 4105936, 4107838, 4105934, 4105907, 4105932, 4105931, 4105933, 4105929, 4105914, 4105927, 4105926, 4105925, 4105924, 4105923, 4105922, 4105921, 4105920, 4105919, 4105918, 4105917, 4105916, 4105915, 4105930, 4107819, 4107840, 4107827, 4107826, 4107825, 4107824, 4107823, 4107822, 4107829, 4107820, 4107830, 4107818, 4107817, 4107806, 4105943, 4106001, 4107851, 4107807, 4107821, 4107839, 4105905, 4107850, 4107846, 4107845, 4107805, 4107844, 4107843, 4107828, 4107841, 4105906, 4107837, 4107836, 4107835, 4107834, 4107833, 4107832, 4107831, 4107842, 4107895, 4107881, 4107882, 4107883, 4107884, 4107885, 4107849, 4107888, 4107890, 4107892, 4105999, 4107894, 4107878, 4106004, 4106003, 4106002, 4106000, 4105998, 4105997, 4105996, 4105995, 4105994, 4107893, 4107868, 4107889, 4107852, 4107860, 4107848, 4107861, 4107862, 4107863, 4107864, 4107865, 4107880, 4107867, 4107879, 4107869, 4107870, 4107871, 4107872, 4107873, 4107874, 4107875, 4107876, 4107877, 4105991, 4107866, 4105955, 4105993, 4105965, 4105964, 4105963, 4105962, 4105961, 4105960, 4105959, 4105958, 4105967, 4105956, 4105968, 4105954, 4105953, 4105952, 4105951, 4105950, 4105949, 4105948, 4105947, 4105946, 4105945, 4105957, 4105979, 4105944, 4105990, 4105989, 4105988, 4105987, 4105986, 4105985, 4105984, 4105983, 4105966, 4105981, 4105992, 4105978, 4105977, 4105976, 4105975, 4105974, 4105973, 4105972, 4105971, 4105970, 4105969, 4105982, 4104102, 4104113, 4104112, 4104111, 4104110, 4104109, 4104108, 4104107, 4104106, 4104105, 4104138, 4104103, 4104116, 4104100, 4104097, 4104096, 4104094, 4104093, 4104092, 4104091, 4104090, 4104089, 4104104, 4104126, 4104137, 4104136, 4104135, 4104134, 4104133, 4104132, 4104131, 4104130, 4104129, 4104114, 4104127, 4104115, 4104125, 4104124, 4104123, 4104122, 4104121, 4104120, 4104119, 4104118, 4104117, 4104086, 4104128, 4104047, 4104088, 4104058, 4104057, 4104056, 4104055, 4104054, 4104053, 4104052, 4104051, 4104060, 4104048, 4104061, 4104046, 4104045, 4104044, 4104043, 4104042, 4104041, 4104040, 4104039, 4107891, 4107853, 4104050, 4104072, 4104101, 4104084, 4104082, 4104081, 4104080, 4104079, 4104078, 4104076, 4104075, 4104059, 4104073, 4104087, 4104071, 4104070, 4104069, 4104068, 4104067, 4104066, 4104065, 4104064, 4104063, 4104062, 4104074, 4107854, 4107855, 4107856, 4107857, 4107858, 4107859, 4104098, 4114939, 4114982, 4114971, 4114995, 4114994, 4114993, 4114991, 4114990, 4114989, 4114986, 4114985, 4114997, 4114983, 4114998, 4114981, 4114980, 4114979, 4114978, 4114977, 4114976, 4114975, 4114974, 4114973, 4115021, 4114984, 4115009, 4115020, 4115019, 4115018, 4115017, 4115016, 4115015, 4115014, 4115013, 4115012, 4114996, 4115010, 4114970, 4115008, 4115007, 4115006, 4115005, 4115004, 4115003, 4115002, 4115001, 4115000, 4114999, 4115011, 4114928, 4114972, 4114940, 4114938, 4114937, 4114936, 4114934, 4114933, 4114932, 4114931, 4114944, 4114929, 4114945, 4114927, 4114926, 4114925, 4114924, 4114923, 4114922, 4114921, 4114920, 4115119, 4114942, 4114930, 4114958, 4114969, 4114968, 4114967, 4114966, 4114965, 4114964, 4114963, 4114962, 4114961, 4114943, 4114959, 4114949, 4114957, 4114956, 4114955, 4114954, 4114953, 4114952, 4114951, 4114950, 4114948, 4114946, 4114960, 4115082, 4115093, 4115092, 4115091, 4115090, 4115089, 4115088, 4115087, 4115086, 4115085, 4115071, 4115083, 4115096, 4115081, 4115080, 4115079, 4115078, 4115077, 4115076, 4115075, 4115074, 4115073, 4115072, 4115084, 4115107, 4115117, 4114947, 4115022, 4115116, 4115115, 4115114, 4115113, 4115112, 4115111, 4115110, 4115094, 4115108, 4115095, 4115106, 4115105, 4115104, 4115103, 4115102, 4115101, 4115100, 4115099, 4115098, 4115097, 4115109, 4115036, 4115050, 4115049, 4115048, 4115023, 4115047, 4115046, 4115045, 4115044, 4115042, 4115040, 4115039, 4115051, 4115037, 4115043, 4115035, 4115034, 4115033, 4115032, 4115031, 4115030, 4115029, 4115028, 4115027, 4115026, 4115070, 4115025, 4115038, 4115061, 4115053, 4115054, 4115055, 4115056, 4115058, 4115052, 4115060, 4115062, 4115063, 4115041, 4115066, 4115067, 4115068, 4115069, 4115059, 4115065, 4111518, 4111496, 4111506, 4111486, 4111550, 4022097, 4022226, 4022180, 4022191, 4035415, 4037307, 4035362, 4010572, 4010591, 4010587, 4018133, 4018067, 4010585, 4018062, 4018056, 4018099, 4018124, 4010561, 4018112, 4018024, 4018080, 4010568, 4010635, 4001399, 4001498, 4001433, 4006695, 4000787, 4002236, 4006721, 4006671, 4046440, 4046439, 4046389, 4046445, 4046400, 4046469, 4046448, 4046480, 4046474, 4046464, 4146670, 4170991, 4170954, 4131043, 4130986, 4122684, 4122670, 4130970, 92532-0001152, 92532-0001231, 92532-0001104, 4105980, 4104049, 4115118, 4114987, 4115024, 4114988, 4115057, 4114935, 4107901, 4107896, 4107897, 4107898, 4107887, 4107900, 4107902, 4107903, 4107899, 4107886, 4107847, 4107904, 4107815, 4107814, 4107813, 4107812, 4107811, 4107810, 4107809, 4107808 and 4107816.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- UNITED STATES, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, CZECHOSLOVAKIA, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GRECE, GUAM, GUATEMALA, HOLLAND, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, LIBYA, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONACO, MORROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SCOTLAND, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM, VIRGIN ISLANDS AND YEMEN.
  • 제품 설명
    Burdick Cardiovive 92532 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). || Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • 제조사 모회사 (2017)
  • Source
    USFDA