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U.S. Department of Health and Human Services

Class 2 Device Recall Natus neoBLUE LED Phototherapy system

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 Class 2 Device Recall Natus neoBLUE LED Phototherapy systemsee related information
Date Initiated by FirmApril 11, 2016
Create DateJune 15, 2016
Recall Status1 Terminated 3 on December 14, 2016
Recall NumberZ-2001-2016
Recall Event ID 73169
510(K)NumberK022196 
Product Classification Unit, neonatal phototherapy - Product Code LBI
ProductNatus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Used to provide treatment for neonatal hyperbilirubinemia
Code Information Serial numbers of units distributed in American Samoa, Guam, Puerto Rico and in the US:  .22938, .23282, .23283, .23289, .23291, .23302, .23307, .23471, .23473, .23478, .23479, .23480, .23481, .23483, .23538, .23697, .23708, .23887, .23888, .23895, .23916, .23939, .23968, .23969, .23972, .23983, .23993, .23994, .23998, 040756-1, 040756-2, 1, 10090, 10507, 10559, 10592, 10595, 10597, 10598, 10613, 10633, 10634, 10635, 10636, 10637, 10638, 10639, 10640, 10642, 10643, 10645, 10646, 10659, 10660, 10661, 10662, 10663, 10666, 10667, 10668, 10671, 10678, 10679, 10680, 10681, 10682, 10683, 10684, 10684, 10685, 10686, 10687, 10688, 10701, 10702, 10703, 10704, 10705, 10706, 10707, 10708, 10709, 10710, 10711, 10712, 10713, 10714, 10715, 10716, 10717, 10718, 10719, 10725, 10727, 10728, 10730, 10731, 10732, 10734, 10739, 10740, 10743, 10744, 10759, 10760, 10761, 10762, 10763, 10764, 10765, 10766, 10767, 10768, 10771, 10773, 10774, 10775, 10776, 10777, 10778, 10779, 10781, 10782, 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   *******************************************************************************************  Serial numbers of units distributed OUTSIDE the US:  .23323, .23329, .23330, .23333, .23340, .23408, .23986, 10673, 10674, 10675, 10676, 10838, 10839, 10840, 10890, 10904, 10932, 11077, 11096, 11097, 11098, 11099, 11101, 12011, 12019, 12210, 12214, 12215, 12216, 12217, 12218, 12219, 12220, 12221, 12222, 12223, 12224, 12225, 12280, 12281, 12282, 12283, 12284, 12285, 12286, 12287, 12288, 12289, 12350, 12408, 12409, 12641, 12980, 13068, 13190, 13438, 13440, 13812, 13813, 13814, 13856, 13857, 13858, 13859, 13863, 13864, 13865, 13867, 13875, 13876, 13888, 13889, 13890, 13891, 13892, 13893, 13894, 13895, 13896, 13897, 13924, 13925, 13926, 13927, 13928, 13929, 13930, 13931, 13933, 13937, 13938, 13939, 13940, 13941, 13942, 13943, 13946, 13947, 13948, 13949, 13950, 13951, 13952, 13953, 13954, 13955, 13956, 13957, 13958, 13969, 13970, 14022, 14023, 14167, 14170, 14171, 14172, 14173, 14241, 14253, 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19558, 19559, 19560, 19561, 19562, 19563, 19564, 19565, 19566, 19567, 19568, 19569, 19570, 19571, 19656, 19657, 19658, 19659, 19660, 19661, 19662, 19663, 19664, 19665, 19666, 19667, 19668, 19669, 19670, 19671, 19672, 19673, 19674, 19675, 19676, 19677, 19678, 19679, 19680, 19681, 19682, 19683, 19684, 19685, 19686, 19687, 19688, 19689, 19690, 19691, 19692, 19693, 19694, 19695, 19696, 19697, 19698, 19699, 19700, 19701, 19702, 19703, 19704, 19705, 19706, 19707, 19708, 19709, 19710, 19711, 19712, 19713, 19714, 19715, 19716, 19717, 19718, 19719, 19720, 19721, 19722, 19723, 19724, 19725, 19726, 19727, 19728, 19729, 19730, 19731, 19732, 19733, 19734, 19735, 19736, 19737, 19738, 19739, 19740, 19741, 19742, 19743, 19744, 19745, 19746, 19747, 19748, 19749, 19750, 19751, 19752, 19753, 19754, 19755, 19757, 19758, 19759, 19760, 19761, 19762, 19763, 19764, 19765, 19766, 19767, 19768, 19769, 19770, 19771, 19772, 19773, 19774, 19775, 19776, 19777, 19778, 19779, 19780, 19781, 19782, 19783, 19784, 19785, 19786, 19787, 19788, 19789, 19790, 19791, 19792, 19793, 19794, 19795, 19796, 19797, 19798, 19799, 19800, 19801, 19802, 19803, 19804, 19805, 19806, 19807, 19808, 19809, 19810, 19811, 19812, 19813, 19814, 19815, 19816, 19817, 19818, 19819, 19820, 19821, 19822, 19823, 19824, 19825, 19826, 19827, 19828, 19829, 19830, 19831, 19832, 19833, 19834, 19835, 19836, 19837, 19838, 19839, 19840, 19841, 19842, 19843, 19844, 19845, 19846, 19847, 19848, 19849, 19850, 19851, 19852, 19853, 19854, 19855, 19856, 19857, 19858, 19859, 19860, 19861, 19862, 19863, 19864, 19865, 19866, 19867, 19868, 19869, 19870, 19871, 19872, 19873, 19874, 19875, 19876, 19877, 19878, 19879, 19880, 19881, 19882, 19883, 19884, 19885, 19886, 19887, 19888, 19889, 19890, 19891, 20512, 20513, 20514, 20515, 20516, 20517, 20518, 20519, 20520, 20521, 20522, 20523, 20524, 20525, 20526, 20527, 20528, 20529, 20530, 20531, 20532, 20533, 20534, 20535, 20536, 20537, 20538, 20539, 20540, 20541, 20542, 20543, 20544, 20545, 20546, 20547, 20548, 20549, 20550, 20551, 20552, 20553, 20554, 20555, 20556, 20557, 20558, 20559, 20560, 20561, 20562, 20563, 20564, 20565, 20566, 20567, 20568, 20569, 20570, 20571, 20572, 20573, 20574, 20575, 20576, 20577, 20578, 20579, 20580, 20581, 20582, 20583, 20584, 20585, 20586, 20587, 20588, 20589, 20590, 20591, 20592, 20593, 20594, 20595, 20596, 20597, 20598, 20599, 20600, 20601, 20602, 20603, 20604, 20605, 20606, 20607, 20608, 20609, 20610, 20611, 20612, 20613, 20614, 20615, 20616, 20617, 20618, 20619, 20620, 20621, 20622, 20623, 20624, 20625, 20626, 20627, 20628, 20629, 20630, 20631, 20632, 20633, 20634, 20635, 20636, 20678, 20679, 20680, 20681, 20682, 20683, 20684, 20685, 20686, 20687, 20688, 20689, 20690, 20691, 20692, 20693, 20694, 20695, 20696, 20697, 20698, 20699, 20700, 20701, 20702, 20703, 20704, 20705, 20706, 20707, 20708, 20709, 20730, 20731, 20732, 20733, 20734, 20735, 20736, 20737, 20738, 20739, 20740, 20741, 20742, 20743, 20744, 20745, 20748, 20753, 20754, 20755, 20756, 20757, 20758, 20759, 20760, 20842, 20843, 20844, 20845, 20846, 20847, 20848, 20849, 20850, 20851, 20896, 20899, 20900, 20902, 20903, 20906, 20908, 20909, 20911, 20913, 20914, 20915, 20919, 20920, 20921, 20938, 20939, 20940, 20941, 20942, 20943, 20944, 20945, 20948, 20996, 20997, 20998, 20999, 21000, 21009, 21010, 21011, 21012, 21013, 21014, 21064, 21065, 21066, 21067, 21069, 21070, 21071, 21072, 21073, 21074, 21077, 21078, 21079, 21080, 21081, 21082, 21083, 21084, 21085, 21086, 21087, 21088, 21089, 21090, 21091, 21099, 21130, 21132, 21133, 21134, 21135, 21136, 21137, 21138, 21139, 21142, 21143, 21144, 21145, 21146, 21147, 21173, 21174, 21175, 21176, 21177, 21178, 21179, 21180, 21181, 21182, 21183, 21184, 21185, 21186, 21187, 21188, 21189, 21190, 21192, 21193, 21194, 21195, 21196, 21197, 21198, 21199, 21200, 21201, 21202, 21203, 21204, 21205, 21206, 21207, 21208, 21209, 21210, 21211, 21212, 21213, 21214, 21215, 21216, 21217, 21218, 21219, 21220, 21221, 21222, 21223, 21224, 21225, 21226, 21227, 21228, 21229, 21230, 21231, 21232, 21233, 21234, 21235, 21236, 21237, 21238, 21239, 21240, 21241, 21242, 21243, 21244, 21245, 21246, 21247, 21248, 21279, 21280, 21305, 21306, 21307, 21308, 21309, 21311, 21312, 21317, 21318, 21319, 21320, 21321, 21322, 21323, 21324, 21325, 21326, 21327, 21328, 21329, 21330, 21331, 21332, 21333, 21334, 21335, 21336, 21337, 21338, 21339, 21340, 21341, 21342, 21343, 21344, 21349, 21350, 21351, 21352, 21353, 21355, 21357, 21358, 21359, 21360, 21361, 21362, 21365, 21366, 21369, 21370, 21375, 21376, 21377, 21378, 21379, 21380, 21381, 21382, 21383, 21384, 21385, 21386, 21387, 21388, 21389, 21390, 21391, 21392, 21393, 21394, 21395, 21396, 21397, 21398, 21399, 21400, 21401, 21402, 21403, 21404, 21405, 21406, 21419, 21420, 21421, 21422, 21423, 21424, 21425, 21426, 21427, 21428, 21429, 21430, 21431, 21432, 21433, 21434, 21435, 21437, 21439, 21440, 21441, 21442, 21443, 21444, 21445, 21446, 21447, 21448, 21449, 21450, 21451, 21452, 21453, 21454, 21455, 21456, 21457, 21458, 21459, 21460, 21461, 21462, 21463, 21464, 21465, 21466, 21467, 21468, 21469, 21470, 21471, 21472, 21473, 21474, 21475, 21476, 21477, 21478, 21479, 21480, 21481, 21482, 21483, 21484, 21485, 21486, 21487, 21488, 21489, 21490, 21491, 21492, 21493, 21494, 21495, 21496, 21497, 21498, 21499, 21500, 21501, 21502, 21503, 21504, 21505, 21506, 21507, 21508, 21509, 21510, 21511, 21512, 21513, 21514, 21515, 21516, 21517, 21518, 21519, 21520, 21521, 21522, 21523, 21524, 21525, 21526, 21527, 21528, 21529, 21530, 21531, 21532, 21533, 21534, 21535, 21536, 21537, 21538, 21539, 21540, 21541, 21542, 21543, 21544, 21545, 21546, 21547, 21548, 21549, 21550, 21551, 21552, 21553, 21554, 21555, 21556, 21557, 21558, 21559, 21560, 21561, 21562, 21563, 21564, 21565, 21566, 21567, 21568, 21569, 21570, 21571, 21572, 21573, 21574, 21575, 21576, 21577, 21578, 21579, 21580, 21581, 21582, 21583, 21584, 21585, 21586, 21587, 21588, 21589, 21590, 21591, 21592, 21593, 21594, 21595, 21596, 21597, 21598, 21599, 21600, 21601, 21602, 21603, 21604, 21605, 21606, 21607, 21608, 21609, 21610, 21611, 21612, 21613, 21615, 21616, 21617, 21618, 21619, 21620, 21621, 21622, 21623, 21624, 21625, 21626, 21627, 21628, 21629, 21630, 21631, 21632, 21633, 21652, 21663, 21697, 21698, 21699, 21700, 21701, 21702, 21703, 21704, 21705, 21706, 21707, 21708, 21709, 21710, 21711, 21712, 21713, 21714, 21715, 21716, 21717, 21718, 21719, 21720, 21721, 21722, 21723, 21724, 21725, 21726, 21727, 21728, 21729, 21730, 21731, 21732, 21733, 21734, 21735, 21736, 21737, 21748, 21749, 21750, 21751, 21752, 21753, 21754, 21755, 21756, 21757, 21758, 21759, 21760, 21761, 21762, 21763, 21764, 21765, 21766, 21767, 21768, 21769, 21770, 21771, 21772, 21773, 21774, 21775, 21776, 21777, 21778, 21779, 21780, 21781, 21782, 21853, 21854, 21855, 21856, 21857, 21858, 21859, 21860, 21861, 21862, 21863, 21864, 21865, 21866, 21867, 21869, 21916, 21917, 21918, 21919, 21920, 21921, 21922, 21923, 21924, 21925, 21926, 21927, 21928, 21929, 21930, 21931, 21932, 21933, 21934, 21935, 21936, 21937, 21938, 21939, 21940, 21941, 21942, 21943, 21944, 21945, 21946, 21947, 21948, 21949, 21950, 21960, 21961, 21962, 21963, 21964, 21965, 21966, 21967, 21968, 21969, 21970, 21981, 21982, 21983, 21984, 21985, 21986, 21988, 22014, 22015, 22016, 22017, 22018, 22019, 22020, 22021, 22022, 22023, 22024, 22025, 22026, 22027, 22028, 22039, 22040, 22041, 22056, 22060, 22065, 22066, 22067, 22068, 22069, 22078, 22079, 22080, 22096, 22097, 22098, 22124, 22125, 22145, 22146, 22147, 22148, 22149, 22150, 22151, 22152, 22182, 22185, 22186, 22190, 22191, 22222, 22229, 22230, 22231, 22232, 22239, 22240, 22241, 22242, 22243, 22244, 22245, 22246, 22247, 22248, 22249, 22250, 22251, 22252, 22253, 22360, 22364, 22365, 22366, 22367, 22368, 22369, 22370, 22371, 22392, 22462, 22463, 22466, 22473, 22474, 22491, 22523, 22526, 22546, 22550, 22551, 22553, 22554, 22555, 22556, 22557, 22558, 22559, 22560, 22561, 22562, 22563, 22564, 22566, 22567, 22597, 22601, 22602, 22604, 22605, 22606, 22614, 22615, 22616, 22617, 22618, 22619, 22620, 22621, 22622, 22623, 22624, 22625, 22626, 22627, 22666, 22670, 22681, 22682, 22692, 22693, 22694, 22695, 22696, 22697, 22698, 22699, 22709, 22710, 22711, 22713, 22714, 22715, 22716, 22717, 22718, 22719, 22720, 22721, 22722, 22723, 22724, 22725, 22726, 22727, 22731, 22732, 22733, 22734, 22735, 22736, 22737, 22738, 22739, 22740, 22741, 22742, 22743, 22744, 22745, 22746, 22747, 22748, 22749, 22750, 22751, 22752, 22753, 22754, 22755, 22756, 22757, 22758, 22759, 22760, 22761, 22762, 22763, 22764, 22765, 22766, 22767, 22768, 22769, 22770, 22771, 22772, 22773, 22774, 22775, 22776, 22777, 22778, 22779, 22780, 22781, 22782, 22783, 22784, 22785, 22786, 22787, 22788, 22789, 22790, 22791, 22792, 22793, 22794, 22795, 22796, 22797, 22798, 22799, 22800, 22801, 22802, 22803, 22804, 22805, 22806, 22807, 22808, 22809, 22810, 22811, 22812, 22813, 22844, 22845, 22849, 22850, 22851, 22854, 22855, 22861, 22862, 22863, 22864, 22866, 22867, 22868, 22869, 22871, 22872, 22873, 22877, 22878, 22879, 22880, 22881, 22882, 22883, 22884, 22885, 22886, 22887, 22888, 22889, 22890, 22891, 22892, 22893, 22894, 22895, 22896, 22897, 22903, 22904, 22905, 22906, 22907, 22908, 22909, 22910, 22911, 22912, 22913, 22914, 22915, 22916, 22934, 22935, 22936, 22937, 22939, 22940, 22941, 22942, 22943, 22944, 22945, 22946, 22947, 22948, 22949, 22950, 22951, 22952, 22953, 22954, 22955, 22956, 22957, 22958, 22959, 22960, 22961, 22962, 22963, 22964, 22965, 22966, 22967, 22968, 22969, 22970, 22971, 22972, 22973, 22974, 22975, 22976, 22977, 22978, 22979, 22981, 22982, 22983, 22984, 22985, 22986, 22987, 22988, 22989, 22990, 22991, 22992, 22993, 22994, 22995, 22996, 22997, 22998, 22999, 23000, 23001, 23002, 23003, 23004, 23005, 23006, 23007, 23008, 23009, 23177, 23178, 23179, 23180, 23181, 23182, 23183, 23184, 23185, 23186, 23199, 23200, 23201, 23202, 23203, 23204, 23205, 23206, 23207, 23208, 23209, 23210, 23211, 23212, 23213, 23214, 23215, 23216, 23217, 23218, 23219, 23220, 23221, 23222, 23223, 23224, 23225, 23226, 23227, 23228, 23229, 23230, 23231, 23232, 23233, 23234, 23235, 23236, 23237, 23238, 23239, 23240, 23241, 23242, 23243, 23244, 23245, 23246, 23247, 23248, 23249, 23250, 23251, 23252, 23253, 23254, 23284, 23285, 23286, 23288, 23290, 23292, 23299, 23300, 23301, 23304, 23306, 23319, 23338, 23339, 23346, 23347, 23348, 23349, 23350, 23351, 23352, 23353, 23354, 23355, 23356, 23357, 23358, 23359, 23360, 23388, 23389, 23390, 23391, 23392, 23400, 23410, 23413, 23414, 23415, 23416, 23417, 23418, 23419, 23420, 23421, 23422, 23423, 23424, 23425, 23426, 23427, 23428, 23429, 23430, 23431, 23432, 23433, 23434, 23435, 23436, 23437, 23438, 23439, 23440, 23441, 23442, 23443, 23444, 23445, 23446, 23447, 23448, 23466, 23470, 23472, 23474, 23475, 23476, 23477, 23482, 23484, 23601, 23662, 23683, 23684, 23685, 23686, 23687, 23688, 23689, 23690, 23691, 23692, 23693, 23694, 23695, 23696, 23698, 23699, 23700, 23702, 23703, 23704, 23706, 23707, 23709, 23732, 23733, 23734, 23735, 23736, 23737, 23738, 23739, 23740, 23741, 23742, 23743, 23744, 23745, 23746, 23747, 23748, 23749, 23750, 23751, 23752, 23753, 23754, 23755, 23756, 23757, 23758, 23759, 23760, 23761, 23762, 23763, 23764, 23765, 23766, 23767, 23768, 23769, 23770, 23771, 23772, 23773, 23774, 23775, 23776, 23777, 23778, 23779, 23780, 23781, 23782, 23783, 23784, 23785, 23786, 23787, 23788, 23789, 23790, 23802, 23830, 23831, 23832, 23833, 23834, 23835, 23836, 23837, 23838, 23839, 23840, 23841, 23842, 23843, 23844, 23845, 23846, 23847, 23848, 23849, 23850, 23851, 23852, 23853, 23854, 23855, 23856, 23857, 23858, 23859, 23872, 23873, 23880, 23881, 23882, 23884, 23885, 23886, 23887, 23888, 23890, 23891, 23893, 23895, 23896, 23897, 23905, 23906, 23908, 23909, 23913, 23914, 23921, 23925, 23946, 23947, 23948, 23949, 23950, 23951, 23952, 23953, 23954, 23955, 23956, 23957, 23958, 23959, 23960, 23961, 23962, 23963, 23964, 23965, 23966, 23971, 23975, 23982, 23984, 23985, 23989, 23990, 23995, 23996, 23997, 24001, 24003, 24004, 24005, 24006, 24007, 24008, 24009, 24010, 24011, 24012, 24013, 24014, 24015, 24016, 24017, 24018, 24019, 24020, 24021, 24022, 24023, 24024, 24025, 24026, 24027, 24028, 24029, 24030, 24031, 24032, 24033, 24034, 24035, 24036, 24037, 24038, 24039, 24040, 24112, 24113, 24114, 24115, 24116, 24117, 24118, 24119, 24120, 24121, 24122, 24123, 24124, 24125, 24126, 24127, 24128, 24129, 24130, 24131, 24132, 24133, 24134, 24135, 24136, 24160, 24161, 24162, 24186, 24187, 24188, 24191, 24192, 24193, 24194, 24195, 24198, 24200, 24201, 24202, 24205, 24207, 24208, 24209, 24213, 24214, 24217, 24218, 24219, 24285, 24286, 24287, 24289, 24290, 24293, 24294, 24295, 24296, 24299, 24321, 24326, 24329, 24330, 24332, 24335, 24338, 24339, 24341, 24343, 24344, 24347, 24348, 24349, 24350, 24352, 24353, 24356, 24357, 24358, 24359, 24362, 24364, 24365, 24366, 24367, 24368, 24371, 24374, 24375, 24377, 24380, 24383, 24384, 24386, 24388, 24389, 24392, 24393, 24395, 24397, 24398, 24401, 24402, 24403, 24404, 24406, 24407, 24410, 24411, 24413, 24415, 24416, 24418, 24497, 24503, 24506, 24509, 24515, 24518, 24563, 24671, 24673, 24674, 24675, 24677, 24680, 24681, 24682, 24683, 24685, 24695, 24698, 24699, 24701, 24703, 24704, 24707, 24708, 24710, 24713, 24716, 24717, 24719, 24722, 24725, 24726, 24728, 24729, 24731, 24734, 24735, 24737, 24739, 24740, 24743, 24746, 24748, 24749, 24752, 24755, 24757, 24758, 24760, 24761, 24764, 24766, 24767, 24770, 24772, 24773, 24774, 24775, 24776, 24779, 24780, 24781, 24782, 24783, 24784, 24785, 24788, 24791, 24792, 24793, 24794, 24796, 24797, 24799, 24800, 24801, 24835, 24836, 24839, 24842, 24843, 24845, 24848, 24851, 24854, 24856, 24900, 24901, 24902, 24905, 24908, 24909, 24910, 24911, 24914, 24915, 24916, 24917, 24920, 24923, 24926, 24928, 24929, 24931, 24932, 24935, 24938, 24942, 24944, 24945, 24947, 24950, 24953, 24954, 24955, 24956, 24959, 24960, 24962, 24965, 24990, 25037, 25040, 25041, 25043, 25046, 25049, 25052, 25055, 25058, 25059, 25061, 25063, 25064, 25067, 25068, 25198, 25199, 25200, 25201, 25202, 25203, 25204, 25205, 25206, 25207, 25208, 25209, 25210, 25211, 25212, 25213, 25214, 25215, 25216, 25217, 25218, 25219, 25220, 25221, 25222, 25223, 25225, 25226, 25227, 25228, 25230, 25231, 25232, 25233, 25234, 25235, 25236, 25237, 25238, 25239, 25240, 25241, 25242, 25243, 25244, 25245, 25246, 25247, 25249, 25250, 25251, 25252, 25253, 25254, 25255, 25256, 25257, 25258, 25259, 25260, 25261, 25262, 25263, 25264, 25265, 25266, 25267, 25268, 25269, 25270, 25271, 25272, 25273, 25274, 25275, 25276, 25277, 25278, 25279, 25280, 25281, 25282, 25283, 25284, 25285, 25286, 25287, 25288, 25289, 25290, 25291, 25341, 25342, 25343, 25344, 25345, 25346, 25347, 25348, 25349, 25350, 25351, 25352, 25353, 25354, 25355, 25357, 25358, 25359, 25360, 25361, 25362, 25363, 25364, 25365, 25366, 25367, 25368, 25369, 25370, 25371, 25372, 25373, 25374, 25375, 25376, 25377, 25378, 25379, 25380, 25381, 25382, 25383, 25384, 25385, 25386, 25387, 25388, 25389, 25390, 25391, 25408, 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50202, 50203, 50204, and 50205.   
Recalling Firm/
Manufacturer
Natus Medical Incorporated
5900 1st Ave S
Seattle WA 98108-3248
For Additional Information ContactNatus Technical Service
888-496-2887
Manufacturer Reason
for Recall
The firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Phototherapy System and provide a laminated Quick Guide to affix to each device.
FDA Determined
Cause 2
Labeling False and Misleading
ActionThe URGENT: FIELD SAFETY NOTICE PRODUCT LABELING CHANGE neoBLUE LED Phototherapy System, dated April 2016, was went to US customers between April 11, 2016 and April 27, 2016. Natus distribution partners outside the US will receive the Letter to Distributors and they are requested to contact their downstream customers to distribute the information. The estimated date of notifying international consignees is May 31, 2016. Enclosed with this letter, customers would receive: 1) Quick Guides (2 each) which provide operating steps, information about measuring intensity, and warnings (PN 051693) 2) User manual addendum 3) Customer reply form Natus requests that this information be distributed to all associated parties within your organization that use or service this product. Please note: this communication is in addition to any prior labeling changes that you may have received from Natus. Customers should submit the Reply Form via fax to 847-949-6031 or email to mailto:Natus_Quality_Programs@natus.com. If there are any questions regarding this letter and addendum, please call Natus Technical Service at 888-496-2887.
Quantity in Commerce13541 units total (7840 units in the US and 5701 units outside the US)
DistributionWorldwide Distributed - US Nationwide in the US including American Samoa, Guam Puerto Rico and in the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bermuda, Bolivia, Brunei Darussalam, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, , Kenya, , Kuwait, Latvia, Lithuania, Malaysia, Moldova Republic of, Morocco, Namibia, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia (Slovak Republic), Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, Virgin Islands (British), and Yemen.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LBI
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