Recall of Device Recall LUCAS 2 Chest Compression System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Jolife AB.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57967
  • Event Risk Class
    Class 3
  • Event Number
    Z-1664-2011
  • Event Initiated Date
    2011-02-08
  • Event Date Posted
    2011-03-16
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2012-04-24
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    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.
  • Extra notes in the data
    External Cardiac Compressor - Product Code DRM
  • Reason
    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

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Jolife AB, Ideon, Scheelev, 17, Lund Sweden
  • Manufacturer Parent Company (2017)
  • Source
    USFDA