Device Recall LUCAS 2 Chest Compression System

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.

Cardiovascular Devices

2

No

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.

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.