Events

Rappel de Device Recall LUCAS 2 Chest Compression System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Jolife AB.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    57967
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1664-2011
  • Date de mise en oeuvre de l'événement
    2011-02-08
  • Date de publication de l'événement
    2011-03-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97868
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    External Cardiac Compressor - Product Code DRM
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Jolife AB, Ideon, Scheelev, 17, Lund Sweden
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA