FDAFDA · Alimentos y medicamentos·N.º oficial Z-0770-2017
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
Publicado el 21 de diciembre de 2016 · Inicio del retiro: 28 de octubre de 2016
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Natus Medical Incorporated
- Distribuidor
- 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).
- Lote
- ************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, 00110
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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