Device Recall VITALITY AVT

  • 모델명 / 제조번호(시리얼번호)
    Model A155, serial numbers: 112541, 112542, 112543, 112544, 112551, 112552, 112553, 112555, 112566, 112602, 112611, 112616, 112619, 112620, 112621, 112623, 112626, 112627, 112628, 112631, 112632, 112633, 112635, 112636, 112640, 112641, 112643, 112645, 112646, 112647, 112648, 112650, 112651, 112652, 112654, 112655, 112656, 112657, 112658, 112661, 112662, 112663, 112664, 112665, 112666, 112672, 112673, 112675, 112679, 112680, 112681, 112682, 112684, 112685, 112686, 112687, 112688, 112691, 112694, 112695, 112696, 112697, 112698, 112699, 112701, 112702, 112703, 112704, 112706, 112708, 112709, 112710, 112713, 112714, 112715, 112716, 112718, 112719, 112721, 112722, 112725, 112729, 112730, 112733, 112735, 112738, 112739, 112740, 112773, 112777, 112778, 112846, 112849, 112850, 112851, 112852, 112853, 112854, 112855, 112856, 112859, 112860, 112861, 112863, 112865, 112892, 113009, 113011, 113078, 113079, 113167, 113184, 113185, 113189, 113196, 113200, 113201, 113202, 113205, 113207, 113209, 113211, 113213, 113215, 113218, 113219, 113220, 113221, 113222, 113226, 113227, 113229, 113230, 113236, 113237, 113238, 113242, 113246, 113251, 113252, 113253, 113255, 113257, 113258, 113260, 113261, 113265, 113266, 113267, 113269, 113272, 113274, 113275, 113282, 113286, 113289, 113293, 113298, 113299, 113302, 113304, 113305, 113307, 113308, 113310, 113311, 113312, 113315, 113316, 113317, 113318, 113319, 113320, 113321, 113322, 113323, 113324, 113326, 113327, 113328, 113329, 113330, 113334, 113335, 113336, 113338, 113339, 113340, 113342, 113343, 113344, 113345, 113346, 113347, 113348, 113351, 113352, 113353, 113360, 113361, 113364, 113368, 113369, 113380, 113381, 113385, 113387, 113389, 113391, 113397, 113398, 113400, 113401, 113412, 113413, 113414, 113415, 113416, 113417, 113418, 113419, 113421, 113422, 113423, 113424, 113425, 113426, 113439, 113442, 113443, 113445, 113446, 113449, 113450, 113451, 113452, 113453, 113454, 113455, 113456, 113458, 113459, 113461, 113463, 113464, 113467, 113468, 113469, 113470, 113471, 113472, 113474, 113476, 113481, 113483, 113484, 113487, 113490, 113491, 113492, 113494, 113495, 113496, 113498, 113499, 113500, 113504, 113505, 113506, 113507, 113508, 113509, 113511, 113512, 113513, 113514, 113515, 113517, 113520, 113521, 113522, 113525, 113527, 113528, 113532, 113534, 113535, 113536, 113537, 113538, 113540, 113543, 113545, 113546, 113547, 113548, 113549, 113550, 113551, 113552, 113553, 113554, 113555, 113556, 113557, 113559, 113560, 113561, 113562, 113564, 113565, 113566, 113577, 113579, 113580, 113583, 113590, 113622, 113625, 113643, 113646, 113647, 113652, 113656, 113662, 113663, 113664, 113665, 113668, 113671, 113692, 113697, 113698, 113702, 113703, 113704, 113705, 113706, 113707, 113708, 113709, 113711, 113713, 113714, 113719, 113724, 113727, 113728, 113730, 113731, 113732, 113734, 113737, 113738, 113740, 113741, 113743, 113744, 113746, 113747, 113749, 113751, 113753, 113754, 113755, 113756, 113757, 113758, 113759, 113760, 113761, 113762, 113763, 113764, 113765, 113767, 113768, 113771, 113772, 113788, 113823, 113826, 113862, 113864, 113865, 113867, 113868, 113869, 113871, 113873, 113875, 113877, 113880, 113882, 113883, 113884, 113887, 113888, 113889, 113890, 113891, 113892, 113894, 113896, 113907, 113916, 113934, 113935, 113936, 113939, 113941, 113943, 113967, 113968, 113970, 113972, 113973, 113974, 113975, 113976, 113978, 113980, 113984, 113985, 113987, 113990, 113992, 113996, 114001, 114002, 114003, 114004, 114005, 114006, 114008, 114009, 114011, 114013, 114019, 114028, 114029, 114032, 114035, 114037, 114038, 114039, 114040, 114047, 114049, 114052, 114053, 114055, 114056, 114057, 114058, 114060, 114065, 114066, 114067, 114068, 114073, 114076, 114077, 114078, 114080, 114081, 114082, 114086, 114087, 114089, 114093, 114103, 114104, 114106, 114107, 114109, 114113, 114118, 114119, 114120, 114121, 114122, 114123, 114126, 114127, 114128, 114133, 114135, 114139, 114140, 114143, 114144, 114145, 114148, 114149, 114150, 114151, 114153, 114155, 114156, 114159, 114160, 114164, 114167, 114172, 114175, 114176, 114179, 114180, 114181, 114182, 114186, 114188, 114194, 114199, 114202, 114203, 114207, 114208, 114211, 114214, 114216, 114217, 114219, 114224, 114226, 114234, 114235, 114241, 114242, 114245, 114248, 114251, 114253, 114258, 114259, 114261, 114266, 114285, 114298, 114301, 114303, 114306, 114325, 114338, 114360, 114419, 114446, 114457, 114465, 114470, 114475, 114476, 114478, 114479, 114491, 114495, 114497, 115043, 115052, 115065, 115070, 115072, 115077, 115078, 115088, 115116, 115120, 115124, 115126, 115132, 115137, 115159, 115208, 115209, 115210, 115211, 115212, 115214, 115215, 115216, 115217, 115218, 115219, 115220, 115221, 115223, 115224, 115225, 115226, 115228, 115229, 115230, 115231, 115232, 115234, 115235, 115236, 115237, 115238, 115239, 115242, 115243, 115244, 115245, 115246, 115248, 115250, 115251, 115252, 115253, 115254, 115255, 115256, 115257, 115258, 115259, 115260, 115262, 115263, 115264, 115267, 115268, 115269, 115270, 115271, 115272, 115274, 115275, 115276, 115277, 115283, 115289, 115290, 115305, 115306, 115310, 115313, 115344, 115347, 115348, 115352, 115370, 115375, 115402, 115410, 115416, 115472, 115488, 115497, 115529, 115539, 115555, 115562, 115616, 115619, 115628, 115639, 115652, 115667, 115671, 115674, 115678, 115679, 115680, 115682, 115686, 115687, 115700, 115703, 115712, 115732, 115733, 115739, 115743, 115754, 115760, 115782, 115795, 115799, 115830, 115859, 115875, 115879, 115977, 116030, 116067, 116069, 116083, 116084, 116087, 116097, 116101.
  • 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
    VITALITY AVT (model A155). Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. 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