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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2001-2016

Natus 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

Publicado el 22 de junio de 2016 · Inicio del retiro: 11 de abril 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

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Natus Medical Incorporated
Distribuidor
Worldwide 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.
Lote
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, 10783, 10784, 10785, 10786, 10787, 10788, 10789, 10791, 10793, 10794, 10795, 10796, 10797, 10799, 10800, 10824, 10825, 10826, 10841, 10842, 10843, 10844, 10846, 10847, 10848, 10849, 10850, 10851, 10852, 10853, 10854, 10855, 10856, 10857, 10858, 10859, 10860, 10863, 10869, 10870, 10871, 10872, 10873, 10875, 10877, 10878, 10879, 10880, 10881, 10882, 10883, 10884, 10885, 10886, 10887, 10888, 10889, 10895, 10896, 10897, 10898, 10899, 10905, 10906, 10907, 10908, 10909, 10910, 10911, 10912, 10913, 10914, 10915, 10916, 10917, 10918, 10919, 10920, 10921, 10922, 10923, 10924, 10927, 10928, 10929, 10930, 10931, 10936, 10937, 10938, 10939, 10962, 10963, 10964, 10965, 10966, 10967, 10968, 10969, 10970, 10971, 10972, 10973, 10974, 10975, 10976, 10977, 10978, 10979, 10980, 10998, 10999, 11000, 11001, 11002, 11003, 11004, 11006, 11007, 11008, 11009, 11013, 11020, 11021, 11022, 11023, 11024, 11025, 11026, 11028, 11029, 11030, 11031, 11032, 11033, 11034, 11035, 11036, 11037, 11038, 11039, 11040, 11041, 11042, 11043, 11044, 11045, 11069, 11070, 11071, 11072, 11073, 11074, 11075, 11076, 11078, 11079, 11080, 11081, 11082, 11083, 11084, 11086, 11087, 11088, 11089, 11090, 11091, 11092, 11093, 11094, 11095, 11102, 11103, 11104, 11105, 11106, 11107, 11108, 11109, 11110, 11112, 11113, 11115, 11116, 11117, 11118, 11119, 11120, 11121, 11122, 11123, 11124, 11125, 11126, 11127, 11128, 11129, 11130, 11131, 11132, 11133, 12001, 12002, 12003, 12005, 12006, 12007, 12008, 12009, 12010, 12017, 12021, 12022, 12023, 12024, 12025, 12027, 12028, 12029, 12030, 12048, 12049, 12050, 12051, 12052, 12053, 12054, 12055, 12056, 12057, 12058, 12059, 12060, 12061, 12062, 12063, 12064, 12065, 12066, 12067, 12068, 12069, 12070, 12071, 12072, 12073, 12074, 12075, 12076, 12077, 12078, 12079, 12080, 12081, 12082, 12083, 12084, 12085, 12088, 12089, 12091, 12094, 12095, 12096, 12097, 12098, 12099, 12100, 12101, 12102, 12103, 12104, 12106, 12107, 12108, 12109, 12110, 12111, 12112, 12113, 12114, 12115, 12116, 12117, 12118, 12119, 12120, 12121, 12122, 12123, 12124, 12125, 12126, 12127, 12128, 12129, 12131, 12132, 12133, 12134, 12135, 12136, 12138, 12142, 12143, 12145, 12146, 12147, 12148, 12149, 12151, 12152, 12153, 12154, 12155, 12156, 12157, 12158, 12159, 12160, 12161, 12162, 12163, 12164, 12165, 12166, 12167, 12168, 12169, 12170, 12172, 12173, 12174, 12175, 12176, 12177, 12178, 12179, 12180, 12181, 12182, 12183, 12184, 12185, 12186, 12187, 12188, 12190, 12191, 12192, 12195, 12200, 12204, 12205, 12206, 12207, 12208, 12209, 12211, 12212, 12213, 12226, 12227, 12228, 12229, 12230, 12231, 12232, 12233, 12234, 12235, 12236, 12237, 12238, 12239, 12240, 12241, 12242, 12243, 12244, 12257, 12276, 12277, 12278, 12290, 12291, 12292, 12293, 12294, 12295, 12296, 12297, 12298, 12299, 12300, 12301, 12302, 12303, 12305, 12306, 12307, 12308, 12309, 12310, 12311, 12312, 12313, 12314, 12327, 12328, 12329, 12330, 12331, 12332, 12333, 12334, 12335, 12336, 12340, 12341, 12342, 12343, 12344, 12345, 12346, 12347, 12348, 12349, 12351, 12352,
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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