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

Recall details

Manufacturer

Natus Medical Incorporated

Distributor

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.

Lot

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,

Risk classification

Class II

Area (FDA)

device

Country

United States