Events

Retiro De Equipo (Recall) de Natus neoBLUE blanket LED Phototherapy system

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Natus Medical Incorporated.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    74587
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0770-2017
  • Fecha de inicio del evento
    2016-10-28
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147989
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Unit, neonatal phototherapy - Product Code LBI
  • Causa
    Neoblue blanket led phototherapy system distributed since release of the product in 2011 is recalled due to customer complaints regarding discoloration/ degradation of fiberoptic bundle at connection of pad and box.
  • Acción
    Natus began sending the URGENT RECALL NOTIFICATION / FIELD SAFETY NOTICE neoBLUE blanket system performance letter dated October 27, 2016 and the Technical Bulletin to US customers on October 28, 2016. Natus plans to notify their international customers on December 2, 2016. Customers were informed in March 2015 of a potential issue of discoloration/degradation/melting of the fiber optic bundle at the pad connector which is inserted in the neoBLUE blanket light box. Included with that letter was a Technical Bulletin which described the issue and addressed many of your potential questions. The purpose of this current letter (dated October 27, 2016) is to communicate Natus' plan for a follow-on field correction for neoBLUE blanket systems shipped between 2011 through March 21, 2016 (Serial Numbers up to and including xxxx004282), and to remind customers of the instructions contained in the neoBLUE blanket Technical Bulletin. Natus is in the process of confirming an updated neoBLUE blanket configuration which will not be susceptible to the degradation described above. However, the date of project completion is uncertain at this time. Natus will contact customers when the new configuration is available, at which time Natus intend to initiate a field corrective action to replace or upgrade your device(s). Please contact Natus Quality_Programs@natus.com if you have any further questions. Please call (800) 426-0353.

Device

Natus neoBLUE blanket LED Phototherapy system
  • Modelo / Serial
    ************SERIAL NUMBERS OF UNITS DISTRIBUTED TO US GOVERMENT ACCOUNTS  000089, 000104, 000128, 001342, 001364, 001367, 001371, 001372, 001373, 001374, 001375, 001376, 001377, 001391, 001392, 001393, 001394, 001441, 001442, 001455, 001456, 001463, 001495, 001496, 001497, 001878, 001893, 001912, 001915, 001992, 001993, 002040, 002041, 002165, 002166, 002167, 002168, 002289, 002290, 002291, 002292, 002320, 002462, 002463, 002762, 002763, 002766, 002860, 002870, 002873, 002888, 003594, 003595, 003600, 003604, 003632, 003633, and 003893.  ***********SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US  ..000284, ..000287, ..000297, ..000299, ..000310, ..000324, ..000328, ..000365, .000301, .000313, .000321, .000322, .000323, .000352, .000415, .000419, .000420, .000426, .000427, .000435, .000445, .000449, .000467, .000483, .000508, .000518, .000523, .000531, .000541, .000581, .000651, .000670, .000695, .000696, .000697, .000698, 000030, 000031, 000032, 000033, 000035, 000036, 000039, 000041, 000042, 000043, 000044, 000046, 000048, 000050, 000051, 000052, 000053, 000056, 000062, 000070, 000076, 000081, 000082, 000085, 000086, 000087, 000088, 000093, 000094, 000139, 000140, 000143, 000144, 000146, 000162, 000163, 000164, 000166, 000167, 000170, 000180, 000181, 000187, 000189, 000190, 000193, 000195, 000202, 000205, 000208, 000215, 000218, 000221, 000223, 000234, 000235, 000238, 000240, 000242, 000243, 000244, 000245, 000246, 000248, 000249, 000250, 000253, 000254, 000255, 000257, 000263, 000275, 000276, 000281, 000290, 000291, 000292, 000293, 000303, 000317, 000320, 000325, 000332, 000333, 000335, 000336, 000340, 000343, 000344, 000345, 000349, 000350, 000351, 000352, 000353, 000354, 000366, 000411, 000414, 000417, 000418, 000422, 000424, 000425, 000428, 000430, 000432, 000436, 000441, 000442, 000443, 000446, 000452, 000453, 000454, 000456, 000457, 000458, 000459, 000460, 000462, 000469, 000472, 000475, 000477, 000479, 000483, 000489, 000493, 000495, 000499, 000500, 000502, 000511, 000516, 000522, 000528, 000530, 000547, 000551, 000553, 000560, 000561, 000563, 000565, 000570, 000574, 000599, 000604, 000615, 000616, 000619, 000620, 000625, 000628, 000631, 000641, 000643, 000646, 000647, 000648, 000655, 000656, 000662, 000664, 000667, 000671, 000675, 000680, 000681, 000682, 000683, 000684, 000687, 000693, 000694, 000697, 000708, 000709, 000711, 000712, 000715, 000717, 000718, 000719, 000720, 000731, 000732, 000734, 000735, 000736, 000740, 000741, 000743, 000744, 000745, 000749, 000751, 000752, 000754, 000758, 000760, 000762, 000763, 000766, 000767, 000768, 000769, 000770, 000771, 000772, 000774, 000775, 000776, 000781, 000782, 000783, 000784, 000785, 000786, 000787, 000788, 000789, 000790, 000792, 000793, 000794, 000796, 000797, 000798, 000799, 000800, 000801, 000802, 000803, 000804, 000805, 000806, 000807, 000808, 000809, 000810, 000812, 000813, 000814, 000815, 000816, 000817, 000818, 000820, 000821, 000822, 000825, 000826, 000831, 000833, 000836, 000847, 000848, 000849, 000850, 000851, 000852, 000854, 000857, 000858, 000859, 000861, 000862, 000863, 000865, 000866, 000867, 000868, 000869, 000870, 000871, 000873, 000874, 000875, 000876, 000877, 000878, 000879, 000880, 000882, 000884, 000891, 000892, 000893, 000899, 000900, 000901, 000902, 000903, 000904, 000905, 000907, 000908, 000909, 000910, 000912, 000913, 000914, 000915, 000916, 000921, 000922, 000923, 000924, 000925, 000935, 000936, 000937, 000938, 000939, 000940, 000941, 000943, 000944, 000945, 000946, 000947, 000950, 000952, 000953, 000957, 000958, 000959, 000960, 000961, 000962, 000963, 000965, 000966, 000967, 000970, 000972, 000973, 000974, 000976, 000978, 000979, 000981, 000988, 000991, 000992, 000993, 001005, 001006, 001010, 001011, 001012, 001013, 001018, 001019, 001020, 001021, 001022, 001031, 001035, 001036, 001037, 001038, 001039, 001040, 001041, 001042, 001043, 001044, 001046, 001047, 001048, 001050, 001056, 001058, 001059, 001085, 001086, 001087, 001088, 001095, 001103, 001104, 001105, 001106, 001109, 001110, 001111, 001113, 001115, 001117, 001118, 001119, 001121, 001122, 001123, 001124, 001125, 001126, 001127, 001128, 001129, 001130, 001131, 001133, 001134, 001135, 001136, 001137, 001138, 001139, 001140, 001141, 001143, 001144, 001146, 001149, 001150, 001153, 001154, 001155, 001156, 001161, 001162, 001163, 001164, 001165, 001166, 001167, 001190, 001205, 001206, 001207, 001208, 001209, 001211, 001213, 001214, 001215, 001216, 001217, 001218, 001219, 001220, 001221, 001222, 001223, 001224, 001225, 001227, 001228, 001230, 001231, 001233, 001235, 001236, 001239, 001241, 001242, 001249, 001252, 001253, 001254, 001255, 001256, 001257, 001260, 001261, 001262, 001265, 001266, 001268, 001269, 001271, 001272, 001274, 001275, 001277, 001280, 001281, 001283, 001288, 001289, 001290, 001291, 001292, 001293, 001294, 001296, 001297, 001299, 001300, 001301, 001302, 001305, 001307, 001309, 001311, 001312, 001315, 001316, 001319, 001321, 001327, 001329, 001330, 001331, 001334, 001335, 001338, 001340, 001346, 001348, 001349, 001350, 001351, 001353, 001354, 001356, 001357, 001360, 001361, 001362, 001363, 001366, 001368, 001370, 001378, 001379, 001380, 001381, 001382, 001383, 001384, 001385, 001386, 001387, 001388, 001389, 001390, 001397, 001398, 001399, 001400, 001401, 001402, 001403, 001404, 001406, 001407, 001408, 001409, 001411, 001414, 001415, 001416, 001419, 001420, 001425, 001427, 001428, 001429, 001430, 001431, 001432, 001433, 001434, 001435, 001436, 001437, 001439, 001440, 001443, 001444, 001445, 001446, 001447, 001452, 001454, 001457, 001467, 001470, 001472, 001473, 001474, 001475, 001476, 001477, 001478, 001481, 001486, 001492, 001494, 001499, 001500, 001503, 001507, 001528, 001532, 001540, 001541, 001542, 001543, 001544, 001545, 001546, 001547, 001548, 001549, 001550, 001551, 001552, 001553, 001554, 001556, 001557, 001558, 001559, 001560, 001562, 001564, 001565, 001566, 001567, 001568, 001569, 001579, 001580, 001581, 001582, 001583, 001584, 001586, 001587, 001588, 001589, 001590, 001591, 001592, 001593, 001594, 001596, 001597, 001598, 001599, 001600, 001601, 001602, 001603, 001607, 001613, 001614, 001615, 001616, 001617, 001618, 001619, 001620, 001622, 001623, 001624, 001625, 001626, 001627, 001629, 001630, 001631, 001632, 001633, 001634, 001636, 001637, 001638, 001640, 001644, 001645, 001646, 001647, 001648, 001649, 001650, 001651, 001652, 001656, 001657, 001658, 001661, 001662, 001663, 001665, 001666, 001667, 001680, 001681, 001682, 001683, 001685, 001686, 001687, 001689, 001691, 001693, 001695, 001696, 001698, 001701, 001702, 001703, 001709, 001711, 001712, 001714, 001715, 001716, 001717, 001718, 001719, 001720, 001721, 001729, 001733, 001738, 001740, 001741, 001742, 001748, 001752, 001753, 001755, 001757, 001758, 001760, 001761, 001762, 001764, 001765, 001766, 001769, 001771, 001772, 001774, 001777, 001779, 001780, 001781, 001785, 001799, 001813, 001814, 001815, 001817, 001818, 001821, 001822, 001823, 001834, 001836, 001840, 001844, 001845, 001846, 001848, 001850, 001851, 001852, 001855, 001856, 001858, 001860, 001861, 001862, 001863, 001864, 001866, 001867, 001868, 001869, 001872, 001873, 001874, 001875, 001876, 001879, 001880, 001881, 001882, 001883, 001890, 001894, 001895, 001896, 001897, 001898, 001899, 001900, 001902, 001903, 001904, 001905, 001906, 001907, 001908, 001909, 001910, 001916, 001917, 001918, 001919, 001920, 001921, 001922, 001923, 001924, 001925, 001926, 001927, 001928, 001929, 001930, 001932, 001935, 001936, 001937, 001938, 001939, 001940, 001941, 001942, 001943, 001946, 001947, 001948, 001949, 001950, 001951, 001953, 001954, 001955, 001956, 001957, 001958, 001959, 001960, 001961, 001962, 001963, 001964, 001965, 001967, 001969, 001970, 001973, 001974, 001979, 001982, 001983, 001984, 001987, 001988, 001990, 001991, 001994, 002001, 002009, 002010, 002014, 002016, 002017, 002018, 002019, 002020, 002021, 002022, 002023, 002024, 002026, 002027, 002031, 002032, 002034, 002037, 002038, 002043, 002044, 002045, 002046, 002047, 002048, 002049, 002075, 002076, 002077, 002078, 002079, 002080, 002086, 002087, 002088, 002089, 002090, 002091, 002092, 002141, 002142, 002143, 002144, 002145, 002146, 002147, 002148, 002150, 002151, 002152, 002154, 002156, 002157, 002158, 002159, 002160, 002161, 002162, 002163, 002164, 002169, 002170, 002171, 002172, 002173, 002175, 002176, 002179, 002180, 002181, 002182, 002183, 002185, 002186, 002198, 002199, 002200, 002201, 002202, 002203, 002208, 002209, 002212, 002215, 002217, 002218, 002219, 002225, 002226, 002227, 002228, 002233, 002234, 002235, 002236, 002237, 002239, 002240, 002241, 002243, 002247, 002248, 002249, 002250, 002252, 002253, 002254, 002259, 002260, 002261, 002262, 002263, 002264, 002266, 002267, 002268, 002269, 002270, 002271, 002272, 002273, 002274, 002275, 002276, 002277, 002281, 002284, 002285, 002286, 002287, 002288, 002293, 002294, 002295, 002296, 002305, 002306, 002308, 002309, 002310, 002311, 002312, 002313, 002315, 002316, 002318, 002319, 002320, 002321, 002322, 002323, 002324, 002325, 002333, 002334, 002335, 002337, 002338, 002339, 002344, 002345, 002352, 002356, 002357, 002359, 002360, 002361, 002363, 002366, 002367, 002368, 002369, 002370, 002372, 002376, 002378, 002379, 002380, 002381, 002382, 002383, 002386, 002387, 002388, 002389, 002392, 002393, 002394, 002395, 002396, 002397, 002398, 002399, 002400, 002401, 002403, 002404, 002409, 002415, 002416, 002417, 002421, 002422, 002429, 002430, 002431, 002432, 002435, 002436, 002437, 002438, 002439, 002440, 002441, 002442, 002443, 002444, 002445, 002446, 002448, 002449, 002451, 002452, 002453, 002454, 002455, 002456, 002457, 002458, 002459, 002460, 002461, 002469, 002471, 002473, 002476, 002478, 002480, 002482, 002483, 002484, 002485, 002486, 002488, 002489, 002490, 002491, 002492, 002493, 002494, 002495, 002496, 002497, 002498, 002499, 002501, 002502, 002503, 002504, 002505, 002506, 002507, 002508, 002509, 002513, 002514, 002516, 002517, 002519, 002520, 002521, 002527, 002528, 002529, 002530, 002533, 002536, 002539, 002543, 002544, 002545, 002546, 002652, 002653, 002654, 002655, 002657, 002658, 002659, 002660, 002661, 002662, 002663, 002669, 002670, 002671, 002672, 002673, 002675, 002676, 002694, 002695, 002696, 002697, 002698, 002699, 002700, 002701, 002702, 002703, 002704, 002715, 002718, 002719, 002722, 002723, 002724, 002727, 002728, 002729, 002732, 002733, 002735, 002736, 002738, 002739, 002751, 002752, 002753, 002754, 002755, 002757, 002758, 002765, 002767, 002768, 002770, 002771, 002773, 002774, 002775, 002776, 002777, 002778, 002779, 002781, 002782, 002783, 002786, 002787, 002790, 002791, 002792, 002793, 002799, 002800, 002801, 002803, 002807, 002808, 002810, 002811, 002812, 002813, 002814, 002815, 002816, 002817, 002818, 002819, 002820, 002821, 002822, 002823, 002824, 002825, 002827, 002828, 002829, 002830, 002831, 002836, 002837, 002838, 002839, 002840, 002841, 002842, 002858, 002859, 002861, 002863, 002866, 002867, 002868, 002869, 002871, 002872, 002874, 002875, 002876, 002877, 002878, 002879, 002880, 002884, 002886, 002887, 002889, 002890, 002891, 002892, 002893, 002894, 002895, 002899, 002910, 002911, 002913, 002914, 002919, 002926, 002931, 002934, 002946, 002947, 002952, 002959, 002960, 002961, 002962, 002963, 002964, 002965, 002966, 002967, 002968, 002969, 002970, 002971, 002972, 002973, 002974, 002975, 002976, 002977, 002979, 002980, 002981, 002982, 002983, 002984, 002985, 002986, 002987, 002988, 002989, 002990, 002991, 002992, 002993, 002994, 003007, 003009, 003010, 003014, 003015, 003016, 003018, 003019, 003020, 003021, 003022, 003023, 003025, 003026, 003027, 003028, 003029, 003030, 003031, 003032, 003033, 003034, 003035, 003036, 003037, 003039, 003040, 003041, 003042, 003043, 003044, 003045, 003046, 003047, 003053, 003068, 003069, 003070, 003071, 003072, 003074, 003075, 003076, 003077, 003078, 003083, 003095, 003102, 003103, 003104, 003105, 003106, 003107, 003108, 003111, 003112, 003113, 003114, 003115, 003116, 003117, 003118, 003119, 003120, 003121, 003122, 003123, 003124, 003125, 003127, 003128, 003129, 003135, 003136, 003137, 003138, 003139, 003140, 003141, 003142, 003143, 003149, 003150, 003151, 003152, 003153, 003154, 003155, 003156, 003160, 003161, 003583, 003584, 003590, 003592, 003593, 003596, 003597, 003601, 003603, 003605, 003606, 003607, 003608, 003609, 003610, 003611, 003613, 003614, 003615, 003616, 003617, 003618, 003619, 003620, 003621, 003622, 003623, 003624, 003625, 003626, 003627, 003629, 003630, 003631, 003634, 003638, 003639, 003640, 003641, 003642, 003643, 003645, 003646, 003647, 003648, 003649, 003650, 003651, 003657, 003658, 003667, 003668, 003669, 003670, 003671, 003672, 003673, 003674, 003675, 003680, 003681, 003682, 003683, 003684, 003685, 003686, 003687, 003688, 003690, 003691, 003692, 003693, 003694, 003695, 003696, 003697, 003698, 003699, 003700, 003701, 003702, 003708, 003709, 003710, 003711, 003712, 003713, 003714, 003715, 003716, 003717, 003718, 003719, 003720, 003721, 003722, 003723, 003724, 003728, 003729, 003730, 003731, 003732, 003733, 003736, 003737, 003739, 003740, 003743, 003744, 003745, 003746, 003747, 003749, 003750, 003751, 003752, 003753, 003754, 003755, 003756, 003757, 003759, 003760, 003761, 003762, 003763, 003765, 003766, 003767, 003772, 003773, 003774, 003775, 003780, 003786, 003788, 003789, 003791, 003792, 003793, 003794, 003795, 003796, 003797, 003798, 003799, 003800, 003801, 003802, 003803, 003804, 003805, 003806, 003809, 003810, 003811, 003812, 003813, 003814, 003815, 003816, 003817, 003821, 003822, 003823, 003832, 003833, 003834, 003836, 003837, 003838, 003840, 003841, 003845, 003846, 003847, 003853, 003855, 003856, 003858, 003859, 003860, 003861, 003862, 003863, 003866, 003868, 003869, 003870, 003871, 003872, 003873, 003875, 003877, 003878, 003879, 003882, 003885, 003891, 003892, 003896, 003898, 003899, 003900, 003904, 003908, 003910, 003911, 003912, 003913, 003915, 003916, 003918, 003919, 003921, 003924, 003926, 003927, 003930, 003932, 003933, 003934, 003935, 003936, 003937, 003938, 003939, 003940, 003941, 003942, 003943, 003944, 003945, 003946, 003947, 003948, 003949, 003950, 003951, 003952, 003953, 003954, 003955, 003957, 003959, 003961, 003962, 003963, 003964, 003965, 003966, 003967, 003968, 003970, 003971, 003972, 003975, 003976, 003977, 003978, 003979, 003980, 003981, 003982, 003983, 003984, 003988, 003989, 003990, 003991, 003992, 003994, 003995, 003996, 003997, 003998, 004000, 004001, 004002, 004003, 004004, 004005, 004006, 004007, 004008, 004010, 004011, 004012, 004013, 004014, 004015, 004016, 004017, 004018, 004019, 004020, 004021, 004022, 004023, 004024, 004026, 004027, 004028, 004029, 004032, 004033, 004034, 004035, 004041, 004042, 004043, 004072, 004207, 004208, 004209, 004210, 004211, 004212, 004213, 004214, 004216, 004217, 004218, 004219, 004220, 004221, 004222, 004223, 004224, 004225, 004226, 004227, 004228, 004229, 004231, 004232, 004233, 004234, 004236, 004237, 004238, 004240, 004241, 004246, 004247, 004248, 004249, 004250, 004251, 004252, 004253, 004254, 004255, 004256, 004257, 004258, 004259, 004260, 004261, 004263, 004264, 004268, 004269, 004270, 004271, 004273, 1215R002299, 2298, 2300, 2302, 2303, 2304, NR002392, R002300, R002301, R002357, R002359, R002360, R002362, R002364, R002365, R002368, R002369, R002370, R002389, R002413, R002415, R002416, and R002417.    ************SERIAL NUMBERS OF UNITS DISTRIBUTED OUTSIDE US   ..000283, 000061, 000064, 000066, 000067, 000069, 000078, 000079, 000121, 000123, 000125, 000129, 000130, 000131, 000136, 000137, 000147, 000148, 000149, 000150, 000152, 000153, 000155, 000168, 000169, 000173, 000174, 000182, 000183, 000192, 000194, 000196, 000198, 000200, 000201, 000211, 000212, 000216, 000219, 000227, 000280, 000295, 000296, 000298, 000300, 000302, 000306, 000309, 000315, 000326, 000334, 000356, 000357, 000368, 000369, 000412, 000423, 000429, 000437, 000451, 000471, 000515, 000521, 000536, 000537, 000539, 000542, 000544, 000548, 000549, 000550, 000581, 000586, 000589, 000590, 000591, 000592, 000593, 000607, 000608, 000609, 000610, 000617, 000624, 000626, 000630, 000633, 000635, 000636, 000637, 000638, 000639, 000642, 000650, 000653, 000654, 000657, 000672, 000673, 000685, 000686, 000691, 000692, 000701, 000706, 000707, 000713, 000714, 000716, 000721, 000723, 000724, 000725, 000726, 000728, 000729, 000737, 000738, 000739, 000746, 000747, 000748, 000757, 000764, 000765, 000777, 000778, 000779, 000780, 000840, 000885, 000886, 000887, 000888, 000889, 000890, 000896, 000897, 000918, 000919, 000920, 000931, 000932, 000933, 000934, 000956, 000975, 000977, 000980, 000994, 000995, 000996, 000997, 001001, 001002, 001007, 001008, 001009, 001014, 001015, 001016, 001017, 001049, 001051, 001052, 001053, 001054, 001055, 001057, 001060, 001061, 001062, 001063, 001064, 001065, 001066, 001069, 001070, 001071, 001072, 001073, 001074, 001075, 001076, 001077, 001078, 001079, 001080, 001081, 001082, 001083, 001084, 001089, 001090, 001091, 001092, 001093, 001097, 001098, 001099, 001100, 001101, 001102, 001114, 001172, 001178, 001179, 001187, 001188, 001192, 001193, 001194, 001198, 001244, 001245, 001246, 001247, 001248, 001250, 001251, 001320, 001325, 001326, 001328, 001332, 001333, 001336, 001339, 001341, 001343, 001345, 001352, 001355, 001358, 001359, 001365, 001395, 001396, 001417, 001418, 001423, 001450, 001451, 001453, 001458, 001459, 001461, 001462, 001479, 001490, 001491, 001509, 001511, 001512, 001513, 001514, 001515, 001516, 001519, 001520, 001521, 001524, 001526, 001561, 001570, 001571, 001572, 001573, 001574, 001576, 001577, 001578, 001604, 001605, 001606, 001608, 001642, 001643, 001659, 001660, 001668, 001669, 001671, 001672, 001673, 001674, 001675, 001676, 001677, 001678, 001694, 001726, 001727, 001728, 001730, 001731, 001732, 001734, 001735, 001736, 001743, 001744, 001745, 001746, 001749, 001750, 001751, 001763, 001773, 001789, 001793, 001796, 001798, 001801, 001802, 001804, 001843, 001859, 001884, 001885, 001888, 001889, 001891, 001892, 001933, 001934, 001968, 001976, 001977, 001985, 001995, 001996, 001997, 001998, 001999, 002000, 002002, 002003, 002004, 002005, 002007, 002011, 002012, 002013, 002025, 002028, 002036, 002039, 002051, 002052, 002053, 002054, 002055, 002056, 002057, 002058, 002059, 002061, 002062, 002065, 002066, 002067, 002068, 002069, 002070, 002071, 002072, 002073, 002074, 002081, 002082, 002083, 002084, 002085, 002187, 002188, 002191, 002192, 002193, 002194, 002195, 002197, 002204, 002205, 002206, 002207, 002210, 002211, 002213, 002214, 002216, 002220, 002221, 002222, 002223, 002224, 002229, 002230, 002231, 002232, 002244, 002245, 002255, 002256, 002257, 002282, 002307, 002318, 002342, 002347, 002350, 002351, 002353, 002354, 002364, 002371, 002372, 002373, 002374, 002375, 002376, 002382, 002383, 002384, 002385, 002391, 002394, 002401, 002402, 002404, 002405, 002406, 002407, 002408, 002409, 002410, 002411, 002412, 002413, 002414, 002423, 002424, 002425, 002426, 002428, 002450, 002464, 002465, 002467, 002477, 002479, 002510, 002511, 002531, 002532, 002534, 002535, 002664, 002665, 002666, 002667, 002668, 002677, 002679, 002681, 002682, 002683, 002684, 002687, 002688, 002689, 002691, 002692, 002693, 002706, 002708, 002709, 002710, 002712, 002713, 002714, 002720, 002730, 002731, 002734, 002737, 002740, 002741, 002742, 002743, 002744, 002745, 002746, 002747, 002748, 002749, 002750, 002756, 002759, 002760, 002761, 002764, 002772, 002797, 002804, 002805, 002806, 002809, 002826, 002834, 002835, 002864, 002865, 002881, 002882, 002916, 002920, 002923, 002927, 002928, 002929, 002930, 002932, 002933, 002935, 002936, 002937, 002938, 002939, 002940, 002941, 002942, 002943, 002944, 002945, 002948, 002949, 002950, 002954, 002955, 002956, 002957, 002996, 002997, 002999, 003000, 003001, 003002, 003003, 003005, 003011, 003012, 003017, 003038, 003051, 003052, 003055, 003056, 003057, 003058, 003059, 003060, 003061, 003062, 003063, 003065, 003066, 003067, 003073, 003081, 003084, 003085, 003086, 003087, 003088, 003089, 003090, 003091, 003092, 003093, 003094, 003096, 003097, 003098, 003099, 003100, 003101, 003130, 003131, 003132, 003133, 003134, 003144, 003145, 003146, 003148, 003157, 003158, 003159, 003162, 003585, 003586, 003587, 003588, 003591, 003598, 003599, 003636, 003637, 003644, 003652, 003653, 003654, 003655, 003656, 003676, 003678, 003704, 003705, 003706, 003707, 003725, 003726, 003727, 003734, 003735, 003738, 003741, 003742, 003770, 003771, 003776, 003777, 003778, 003779, 003781, 003782, 003790, 003807, 003808, 003818, 003819, 003820, 003835, 003842, 003843, 003844, 003848, 003849, 003850, 003851, 003852, 003854, 003864, 003865, 003867, 003876, 003880, 003881, 003884, 003886, 003887, 003888, 003890, 003895, 003897, 003902, 003903, 003905, 003906, 003907, 003909, 003917, 003923, 003925, 003931, 003960, 003969, 003993, 004242, 004243, 004267, 004272, 1517, 1911000001, NR002393, R002358, R002366, R002371, R002390, and R002414.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : including American Samoa and Guam, and in the following countries: Albania, Argentina, Australia, Austria, Bangladesh, Canada, Chile, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Hong Kong, Indonesia, Iraq, Israel, Italy, Korea, Kuwait, Latvia, Malaysia, Mongolia, Namibia, Netherlands, Nigeria, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia (Slovak Republic), Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, and Virgin Islands (British).
  • Descripción del producto
    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. || 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad || 006254 neoBLUE blanket LED Light Box || 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad || 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR || 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR || 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK || 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK || 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS || 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
  • Manufacturer
    Natus Medical Incorporated

Manufacturer

Natus Medical Incorporated
  • Dirección del fabricante
    Natus Medical Incorporated, 5900 1st Ave S, Seattle WA 98108-3248
  • Empresa matriz del fabricante (2017)
    Natus Medical Incorporated
  • Source
    USFDA