Events

Device Recall LUCAS 2 Chest Compression System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Jolife AB 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    57967
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1664-2011
  • 사례 시작날짜
    2011-02-08
  • 사례 출판 날짜
    2011-03-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97868
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    External Cardiac Compressor - Product Code DRM
  • 원인
    Lucas 2 chest compression system may have malfunctions resulting from the failure of a hood probe on the device that connects to the battery. the device may stop in fail safe mode and the leds will start flickering or the device will switch off.
  • 조치
    Medical Device Correction letter, dated February 2011, was sent to customers and states that Jolife AB with the servicing support assistant of Physio-Control is conducting a voluntary upgrade of the LUCAS 2 Chest Compression System with the Serial number range of 30090016 through 30101932. Consignees were advised to keep LUCAS 2 in service and continue to use it in accordance with the Instruction for Use, Section 3.8-Safety Precautions. WARNING-MALFUNCTION. If there are interruptions, or the compressions are not sufficient or something unusual occurs during operation: Push ON/OFF for 1 second to stop LUCAS and remove the device. Start Manual chest compression. Physio-Control service representative will contact the consignees to schedule a service call to replace the affected battery connector board in the hood of the device. The new connector board will include a new probe design in which current cannot affect the spring. Consignees can contact Physio-Control Technical Support at 1-800-442-1142, #5 between 6 am-4 pm (Pacific Time), Monday-Friday or visit the website www.physio-control-notices.com/LUCAS2. If customers no longer have the affected device or the device location has changed they should contact Physio-Control Technical Support.

Device

Device Recall LUCAS 2 Chest Compression System
  • 모델명 / 제조번호(시리얼번호)
    SERIAL NUMBERS for 546 UNITS DISTRIBUTED BY PHYSIO-CONTROL IN THE US: 30090182, 30090188, 30090216, 30090232, 30090242, 30090273, 30090275, 30090276, 30090277, 30090278, 30090279, 30090280, 30090281, 30090282, 30090284, 30090285, 30090286, 30090305, 30090314, 30090318, 30090325, 30090327, 30090328, 30090331, 30090333, 30090335, 30090426, 30090428, 30090429, 30090430, 30090432, 30090433, 30090434, 30090436, 30090437, 30090438, 30090439, 30090440, 30090442, 30090443, 30090445, 30090448, 30090449, 30090450, 30090451, 30090452, 30090453, 30090454, 30090457, 30090458, 30090459, 30090460, 30090461, 30090471, 30090499, 30090500, 30090501, 30090502, 30090503, 30090504, 30090505, 30090506, 30090507, 30090508, 30090509, 30090510, 30090511, 30090512, 30090513, 30090514, 30090515, 30090516, 30090517, 30090550, 30090564, 30090565, 30090566, 30090567, 30090568, 30090569, 30090575, 30090577, 30090580, 30090581, 30090583, 30090584, 30090629, 30090633, 30090653, 30090661, 30090665, 30090666, 30090670, 30090671, 30090672, 30090673, 30090674, 30090675, 30090676, 30090677, 30090678, 30090679, 30090680, 30090681, 30090682, 30100752, 30100753, 30100754, 30100755, 30100756, 30100757, 30100758, 30100759, 30100760, 30100761, 30100762, 30100763, 30100764, 30100765, 30100816, 30100817, 30100818, 30100819, 30100820, 30100821, 30100822, 30100823, 30100824, 30100825, 30100826, 30100827, 30100828, 30100829, 30100830, 30100831, 30100832, 30100834, 30100835, 30100838, 30100839, 30100840, 30100841, 30100842, 30100843, 30100844, 30100845, 30100846, 30100847, 30100848, 30100849, 30100850, 30100851, 30100852, 30100853, 30100854, 30100856, 30100858, 30100859, 30100860, 30100861, 30100863, 30100867, 30100868, 30100873, 30100898, 30100909, 30100944, 30100945, 30100946, 30100947, 30100948, 30100949, 30100950, 30100951, 30100952, 30100953, 30100954, 30100955, 30100956, 30100957, 30100958, 30100959, 30100960, 30100961, 30100962, 30100963, 30100964, 30100965, 30100966, 30100967, 30100968, 30100969, 30100970, 30100971, 30100972, 30100973, 30100974, 30100975, 30100976, 30100977, 30100978, 30100979, 30100980, 30100982, 30100983, 30100984, 30100986, 30101060, 30101062, 30101063, 30101064, 30101065, 30101066, 30101067, 30101074, 30101075, 30101077, 30101084, 30101085, 30101086, 30101087, 30101088, 30101124, 30101125, 30101160, 30101170, 30101171, 30101172, 30101173, 30101174, 30101175, 30101176, 30101177, 30101178, 30101179, 30101180, 30101181, 30101182, 30101183, 30101184, 30101185, 30101186, 30101187, 30101188, 30101189, 30101190, 30101191, 30101192, 30101193, 30101194, 30101195, 30101196, 30101197, 30101198, 30101199, 30101200, 30101201, 30101202, 30101203, 30101204, 30101205, 30101206, 30101207, 30101208, 30101209, 30101210, 30101211, 30101212, 30101213, 30101214, 30101215, 30101216, 30101217, 30101218, 30101219, 30101220, 30101221, 30101222, 30101223, 30101224, 30101225, 30101226, 30101227, 30101228, 30101229, 30101230, 30101231, 30101232, 30101233, 30101234, 30101235, 30101236, 30101237, 30101252, 30101254, 30101265, 30101266, 30101267, 30101268, 30101276, 30101277, 30101278, 30101279, 30101280, 30101281, 30101282, 30101283, 30101284, 30101285, 30101286, 30101287, 30101288, 30101290, 30101292, 30101293, 30101294, 30101295, 30101333, 30101334, 30101337, 30101338, 30101343, 30101344, 30101345, 30101346, 30101347, 30101349, 30101350, 30101351, 30101353, 30101354, 30101355, 30101356, 30101380, 30101381, 30101382, 30101386, 30101388, 30101389, 30101391, 30101392, 30101393, 30101394, 30101395, 30101396, 30101397, 30101398, 30101399, 30101400, 30101401, 30101402, 30101403, 30101404, 30101405, 30101406, 30101407, 30101408, 30101409, 30101411, 30101412, 30101413, 30101414, 30101452, 30101453, 30101455, 30101456, 30101457, 30101459, 30101460, 30101463, 30101464, 30101465, 30101473, 30101475, 30101476, 30101481, 30101495, 30101496, 30101497, 30101503, 30101504, 30101505, 30101506, 30101507, 30101508, 30101509, 30101510, 30101511, 30101512, 30101513, 30101514, 30101515, 30101516, 30101517, 30101518, 30101519, 30101520, 30101521, 30101522, 30101523, 30101524, 30101525, 30101526, 30101527, 30101528, 30101529, 30101530, 30101531, 30101532, 30101533, 30101534, 30101535, 30101536, 30101537, 30101538, 30101539, 30101540, 30101541, 30101542, 30101544, 30101545, 30101547, 30101548, 30101549, 30101551, 30101553, 30101554, 30101555, 30101556, 30101557, 30101559, 30101560, 30101573, 30101576, 30101577, 30101578, 30101579, 30101584, 30101607, 30101609, 30101610, 30101611, 30101612, 30101614, 30101615, 30101616, 30101617, 30101618, 30101620, 30101621, 30101622, 30101623, 30101624, 30101661, 30101662, 30101663, 30101665, 30101666, 30101667, 30101668, 30101670, 30101673, 30101674, 30101675, 30101676, 30101677, 30101678, 30101679, 30101681, 30101682, 30101683, 30101690, 30101696, 30101698, 30101701, 30101704, 30101705, 30101706, 30101707, 30101709, 30101724, 30101725, 30101726, 30101727, 30101728, 30101729, 30101730, 30101731, 30101732, 30101733, 30101734, 30101735, 30101736, 30101737, 30101751, 30101752, 30101762, 30101788, 30101789, 30101790, 30101791, 30101792, 30101793, 30101794, 30101795, 30101796, 30101797, 30101798, 30101799, 30101800, 30101805, 30101806, 30101808, 30101811, 30101814, 30101815, 30101816, 30101817, 30101818, 30101820, 30101821, 30101865, 30101866, 30101867, 30101868, 30101869, 30101870, 30101871, 30101872, 30101873, 30101874, 30101875, 30101876, 30101878, 30101879, 30101880, 30101881, 30101882, 30101883, 30101885, 30101887, 30101919, 30101921, 30101923, 30101927, and 30101928.   SERIAL NUMBERS FOR 892 UNITS DISTRIBUTED BY PHYSIO-CONTROL TO THEIR FOREIGN CONSIGNEES: 30090054, 30090055, 30090059, 30090060, 30090061, 30090062, 30090063, 30090064, 30090065, 30090067, 30090068, 30090069, 30090070, 30090071, 30090072, 30090073, 30090074, 30090075, 30090076, 30090077, 30090078, 30090079, 30090080, 30090081, 30090082, 30090083, 30090084, 30090085, 30090087, 30090088, 30090111, 30090112, 30090113, 30090114, 30090115, 30090116, 30090117, 30090141, 30090142, 30090164, 30090165, 30090166, 30090168, 30090169, 30090171, 30090172, 30090173, 30090174, 30090175, 30090178, 30090180, 30090181, 30090183, 30090184, 30090185, 30090186, 30090187, 30090189, 30090190, 30090191, 30090192, 30090193, 30090194, 30090195, 30090196, 30090197, 30090198, 30090199, 30090206, 30090208, 30090209, 30090213, 30090221, 30090223, 30090224, 30090225, 30090226, 30090228, 30090233, 30090235, 30090237, 30090238, 30090239, 30090240, 30090241, 30090243, 30090244, 30090245, 30090246, 30090247, 30090248, 30090249, 30090250, 30090251, 30090252, 30090253, 30090254, 30090255, 30090256, 30090257, 30090258, 30090259, 30090260, 30090261, 30090262, 30090263, 30090264, 30090265, 30090266, 30090267, 30090268, 30090269, 30090270, 30090271, 30090272, 30090274, 30090283, 30090287, 30090288, 30090289, 30090290, 30090291, 30090292, 30090293, 30090294, 30090295, 30090296, 30090297, 30090298, 30090299, 30090300, 30090301, 30090302, 30090303, 30090304, 30090306, 30090307, 30090308, 30090309, 30090310, 30090311, 30090312, 30090313, 30090317, 30090319, 30090320, 30090321, 30090323, 30090324, 30090329, 30090330, 30090332, 30090334, 30090336, 30090337, 30090338, 30090339, 30090340, 30090341, 30090342, 30090343, 30090344, 30090345, 30090346, 30090347, 30090348, 30090349, 30090350, 30090351, 30090352, 30090353, 30090354, 30090355, 30090356, 30090357, 30090358, 30090359, 30090360, 30090361, 30090362, 30090363, 30090364, 30090365, 30090366, 30090367, 30090368, 30090369, 30090370, 30090371, 30090372, 30090373, 30090374, 30090375, 30090376, 30090377, 30090378, 30090379, 30090380, 30090381, 30090382, 30090383, 30090384, 30090385, 30090386, 30090387, 30090388, 30090389, 30090390, 30090391, 30090392, 30090393, 30090394, 30090395, 30090396, 30090397, 30090398, 30090399, 30090400, 30090401, 30090402, 30090403, 30090404, 30090405, 30090406, 30090407, 30090408, 30090409, 30090410, 30090411, 30090412, 30090413, 30090414, 30090415, 30090416, 30090417, 30090418, 30090419, 30090420, 30090421, 30090422, 30090423, 30090424, 30090425, 30090427, 30090455, 30090456, 30090462, 30090463, 30090464, 30090524, 30090525, 30090526, 30090527, 30090528, 30090536, 30090544, 30090547, 30090548, 30090551, 30090552, 30090553, 30090554, 30090556, 30090559, 30090560, 30090561, 30090562, 30090563, 30090585, 30090586, 30090587, 30090589, 30090590, 30090591, 30090592, 30090593, 30090594, 30090595, 30090596, 30090597, 30090598, 30090599, 30090600, 30090601, 30090602, 30090603, 30090604, 30090605, 30090606, 30090607, 30090608, 30090609, 30090610, 30090611, 30090612, 30090613, 30090614, 30090615, 30090634, 30090637, 30090640, 30090641, 30090642, 30090643, 30090644, 30090646, 30090647, 30090650, 30090651, 30090652, 30090654, 30090655, 30090656, 30090657, 30090658, 30090659, 30090660, 30090662, 30090663, 30090664, 30090694, 30090695, 30090696, 30090697, 30090698, 30090699, 30090700, 30090701, 30090702, 30090703, 30090704, 30090705, 30090706, 30090707, 30090708, 30090710, 30090711, 30090712, 30090713, 30090714, 30100766, 30100767, 30100768, 30100769, 30100770, 30100771, 30100772, 30100773, 30100774, 30100775, 30100776, 30100777, 30100778, 30100779, 30100780, 30100781, 30100782, 30100783, 30100784, 30100785, 30100786, 30100787, 30100788, 30100789, 30100790, 30100791, 30100792, 30100793, 30100794, 30100795, 30100796, 30100797, 30100798, 30100799, 30100800, 30100801, 30100802, 30100803, 30100804, 30100805, 30100806, 30100807, 30100808, 30100809, 30100810, 30100811, 30100812, 30100813, 30100814, 30100815, 30100862, 30100870, 30100871, 30100872, 30100874, 30100875, 30100882, 30100883, 30100884, 30100885, 30100886, 30100887, 30100888, 30100889, 30100890, 30100891, 30100892, 30100893, 30100894, 30100895, 30100896, 30100897, 30100899, 30100900, 30100901, 30100902, 30100903, 30100904, 30100905, 30100906, 30100907, 30100908, 30100910, 30100911, 30100912, 30100913, 30100914, 30100915, 30100916, 30100917, 30100918, 30100919, 30100920, 30100921, 30100922, 30100923, 30100924, 30100925, 30100926, 30100927, 30100928, 30100929, 30100930, 30100931, 30100932, 30100933, 30100934, 30100935, 30100936, 30100937, 30100938, 30100939, 30100940, 30100941, 30100942, 30100943, 30100987, 30100988, 30100989, 30100990, 30100991, 30100992, 30100993, 30100994, 30100995, 30100996, 30100997, 30101000, 30101001, 30101002, 30101003, 30101004, 30101005, 30101006, 30101007, 30101008, 30101009, 30101029, 30101036, 30101046, 30101055, 30101056, 30101057, 30101058, 30101059, 30101061, 30101068, 30101069, 30101070, 30101071, 30101072, 30101073, 30101076, 30101078, 30101079, 30101080, 30101081, 30101082, 30101083, 30101089, 30101092, 30101093, 30101094, 30101095, 30101096, 30101097, 30101098, 30101099, 30101100, 30101101, 30101102, 30101103, 30101104, 30101105, 30101106, 30101107, 30101108, 30101109, 30101110, 30101111, 30101112, 30101113, 30101114, 30101115, 30101116, 30101117, 30101118, 30101119, 30101120, 30101122, 30101123, 30101126, 30101128, 30101129, 30101130, 30101131, 30101132, 30101133, 30101136, 30101138, 30101143, 30101144, 30101147, 30101149, 30101150, 30101151, 30101152, 30101153, 30101154, 30101159, 30101239, 30101244, 30101245, 30101246, 30101248, 30101249, 30101251, 30101255, 30101256, 30101257, 30101258, 30101259, 30101260, 30101261, 30101262, 30101263, 30101264, 30101269, 30101270, 30101271, 30101272, 30101273, 30101274, 30101275, 30101291, 30101296, 30101297, 30101298, 30101299, 30101300, 30101301, 30101302, 30101304, 30101305, 30101306, 30101307, 30101308, 30101309, 30101310, 30101311, 30101312, 30101313, 30101314, 30101316, 30101317, 30101318, 30101320, 30101321, 30101322, 30101323, 30101324, 30101325, 30101326, 30101327, 30101328, 30101329, 30101330, 30101331, 30101332, 30101337, 30101340, 30101341, 30101348, 30101358, 30101359, 30101360, 30101361, 30101362, 30101363, 30101364, 30101365, 30101366, 30101367, 30101368, 30101369, 30101370, 30101371, 30101372, 30101373, 30101374, 30101375, 30101376, 30101377, 30101378, 30101379, 30101415, 30101416, 30101417, 30101418, 30101419, 30101420, 30101421, 30101422, 30101423, 30101424, 30101425, 30101426, 30101427, 30101428, 30101429, 30101430, 30101431, 30101434, 30101435, 30101436, 30101437, 30101438, 30101439, 30101440, 30101441, 30101442, 30101443, 30101444, 30101445, 30101446, 30101447, 30101448, 30101449, 30101450, 30101451, 30101454, 30101458, 30101461, 30101462, 30101466, 30101467, 30101468, 30101469, 30101470, 30101471, 30101472, 30101474, 30101477, 30101478, 30101479, 30101480, 30101482, 30101483, 30101484, 30101485, 30101486, 30101487, 30101488, 30101490, 30101491, 30101492, 30101493, 30101494, 30101498, 30101499, 30101500, 30101501, 30101502, 30101552, 30101561, 30101562, 30101563, 30101564, 30101565, 30101566, 30101567, 30101568, 30101569, 30101570, 30101571, 30101572, 30101574, 30101575, 30101580, 30101581, 30101582, 30101583, 30101585, 30101586, 30101587, 30101588, 30101589, 30101590, 30101591, 30101592, 30101593, 30101594, 30101595, 30101596, 30101597, 30101598, 30101599, 30101600, 30101602, 30101603, 30101604, 30101605, 30101606, 30101608, 30101613, 30101625, 30101626, 30101627, 30101628, 30101629, 30101631, 30101632, 30101633, 30101634, 30101635, 30101636, 30101637, 30101638, 30101639, 30101640, 30101641, 30101642, 30101643, 30101644, 30101645, 30101646, 30101647, 30101648, 30101649, 30101650, 30101651, 30101652, 30101653, 30101654, 30101655, 30101656, 30101657, 30101658, 30101659, 30101660, 30101684, 30101685, 30101686, 30101687, 30101688, 30101689, 30101691, 30101692, 30101693, 30101694, 30101695, 30101697, 30101699, 30101700, 30101702, 30101703, 30101708, 30101710, 30101711, 30101712, 30101713, 30101714, 30101715, 30101716, 30101717, 30101718, 30101719, 30101720, 30101721, 30101722, 30101723, 30101738, 30101739, 30101740, 30101741, 30101742, 30101743, 30101745, 30101746, 30101747, 30101748, 30101749, 30101750, 30101753, 30101754, 30101755, 30101756, 30101757, 30101758, 30101759, 30101760, 30101761, 30101764, 30101768, 30101771, 30101773, 30101775, 30101776, 30101778, 30101779, 30101781, 30101783, 30101786, 30101787, 30101801, 30101802, 30101803, 30101804, 30101813, 30101819, 30101822, 30101823, 30101824, 30101825, 30101826, 30101827, 30101828, 30101829, 30101830, 30101832, 30101833, 30101834, 30101835, 30101836, 30101837, 30101838, 30101839, 30101840, 30101841, 30101846, 30101848, 30101850, 30101851, 30101852, 30101853, 30101854, 30101855, 30101856, 30101857, 30101858, 30101859, 30101860, 30101893, 30101909, 30101910, 30101911, 30101912, 30101913, 30101914, 30101916, 30101930, and 30101932.    SERIAL NUMBERS FOR 224 DEMO UNITS OWNED by PHYSIO-CONTROL: 30090026, 30090027, 30090028, 30090029, 30090031, 30090032, 30090033, 30090034, 30090035, 30090086, 30090089, 30090090, 30090091, 30090092, 30090093, 30090094, 30090095, 30090096, 30090097, 30090098, 30090099, 30090100, 30090102, 30090103, 30090104, 30090105, 30090106, 30090108, 30090109, 30090110, 30090118, 30090119, 30090120, 30090121, 30090122, 30090123, 30090124, 30090125, 30090126, 30090127, 30090128, 30090129, 30090130, 30090131, 30090132, 30090133, 30090134, 30090135, 30090136, 30090137, 30090138, 30090139, 30090140, 30090143, 30090144, 30090145, 30090146, 30090147, 30090148, 30090149, 30090150, 30090151, 30090152, 30090153, 30090154, 30090155, 30090156, 30090157, 30090158, 30090160, 30090161, 30090162, 30090163, 30090167, 30090170, 30090200, 30090201, 30090202, 30090203, 30090204, 30090205, 30090207, 30090210, 30090211, 30090212, 30090214, 30090215, 30090217, 30090218, 30090219, 30090220, 30090222, 30090227, 30090229, 30090230, 30090231, 30090234, 30090236, 30090326, 30090441, 30090444, 30090446, 30090447, 30090466, 30090467, 30090468, 30090469, 30090470, 30090472, 30090473, 30090474, 30090475, 30090476, 30090477, 30090478, 30090479, 30090480, 30090481, 30090482, 30090483, 30090484, 30090485, 30090486, 30090487, 30090488, 30090489, 30090490, 30090491, 30090492, 30090493, 30090494, 30090495, 30090496, 30090497, 30090498, 30090518, 30090519, 30090520, 30090521, 30090522, 30090523, 30090529, 30090530, 30090531, 30090532, 30090533, 30090534, 30090535, 30090537, 30090538, 30090539, 30090540, 30090541, 30090542, 30090543, 30090545, 30090546, 30090549, 30090555, 30090557, 30090558, 30090570, 30090571, 30090572, 30090573, 30090574, 30090576, 30090578, 30090579, 30090582, 30090588, 30090616, 30090617, 30090618, 30090619, 30090620, 30090621, 30090622, 30090623, 30090624, 30090625, 30090626, 30090627, 30090628, 30090630, 30090631, 30090632, 30090635, 30090636, 30090638, 30090639, 30090645, 30090683, 30090684, 30090685, 30090686, 30090687, 30090688, 30090689, 30090690, 30090691, 30090692, 30090693, 30100880, 30100881, 30100985, 30101090, 30101091, 30101289, 30101335, 30101336, 30101339, 30101342, 30101352, 30101383, 30101384, 30101385, 30101387, 30101390, 30101410, 30101619, 30101669, 30101672, and 30101680.   SERIAL NUMBERS FOR 181 UNITS DISTRIBUTED BY JOLIFE, SWEDEN:  30090016, 30090018, 30090019, 30090020, 30090021, 30090022, 30090023, 30090024, 30090025, 30090030, 30090036, 30090037, 30090038, 30090039, 30090040, 30090041, 30090042, 30090043, 30090044, 30090045, 30090046, 30090047, 30090048, 30090049, 30090050, 30090051, 30090052, 30090053, 30090056, 30090057, 30090058, 30090101, 30090107, 30090159, 30090315, 30090316, 30090322, 30090431, 30090431, 30090435, 30090465, 30090648, 30090649, 30090667, 30090668, 30090669, 30090709, 30090715, 30090716, 30090717, 30090718, 30090719, 30090720, 30090721, 30090722, 30090723, 30090724, 30090725, 30090726, 30090727, 30090728, 30090729, 30090730, 30090731, 30090732, 30090733, 30090734, 30090735, 30090736, 30090737, 30090738, 30090739, 30090740, 30100741, 30100742, 30100743, 30100744, 30100745, 30100746, 30100747, 30100748, 30100749, 30100750, 30100751, 30100833, 30100836, 30100837, 30100855, 30100857, 30100864, 30100865, 30100866, 30100869, 30100876, 30100877, 30100878, 30100879, 30100998, 30100999, 30101010, 30101011, 30101012, 30101013, 30101014, 30101015, 30101016, 30101017, 30101018, 30101019, 30101020, 30101021, 30101022, 30101023, 30101024, 30101025, 30101026, 30101027, 30101028, 30101030, 30101031, 30101032, 30101033, 30101034, 30101035, 30101037, 30101038, 30101039, 30101040, 30101041, 30101042, 30101043, 30101044, 30101045, 30101047, 30101048, 30101049, 30101050, 30101051, 30101052, 30101053, 30101054, 30101121, 30101127, 30101134, 30101135, 30101137, 30101139, 30101140, 30101141, 30101142, 30101145, 30101146, 30101148, 30101155, 30101156, 30101157, 30101158, 30101161, 30101162, 30101163, 30101164, 30101165, 30101166, 30101167, 30101168, 30101169, 30101238, 30101240, 30101241, 30101242, 30101243, 30101247, 30101250, 30101253, 30101303, 30101315, 30101319, 30101432, 30101433, 30101766,  and 30101886.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States, Australia, Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, United Arab Emirates, and United Kingdom.
  • 제품 설명
    LUCAS 2 Chest Compression System. || The device's Instruction for Use is labeled in part: "LUCAS 2 Chest Compression System***jolife***www.lucas-cpr.com***a product by JOLIFE***MANUFACTURER, MAIN OFFICE JOLIFE AB Scheelevagen 17 SE-223 70 LUND Sweden***www.jolife.com***". || Designed to uninterrupted chest compressions at a consistent rate and depth.
  • Manufacturer
    Jolife AB

Manufacturer

Jolife AB
  • 제조사 주소
    Jolife AB, Ideon, Scheelev, 17, Lund Sweden
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA