FDAFDA · Food and drugs·Recall number Z-1924-2017
Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Device is used to provide treatment for neonatal hyperbilirubinemia.
Published May 10, 2017 · Recall initiated: April 3, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The second generation neoBLUE 2 lights with a black band, sold from 2003 to 2008, are recalled so it will eliminate the possibility that a neoBLUE system may have a replacement board installed which allows it to be used at a higher overall light intensity than the devices were originally cleared to deliver.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Natus Medical Incorporated
- Distributor
- Worldwide Distribution - US Nationwide and in the following countries: Argentina, Australia, Austria, Belgium, Bermuda, Canada, Colombia, Croatia, Denmark, Germany, Greece, Hungary, India, Indonesia, Israel, Italy, Japan, Kenya, Kuwait, Lithuania, Morocco, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Virgin Islands (British).
- Lot
- SERIAL NUMBERS OF UNITS DISTRIBUTED TO US GOVERMENT CONSIGNEES: 12443, 12444, 12445, 12951, 13157, 13158, 13169, 14230, 16746, 16747, 16759, 16760, 16761, 16762, 16763, 16764, 16765, 16766, 16767, 16768, 16769, 16770, 16771, 16772, 16773, 16774, 16784, and 16785. **************************************************************************************************** SERIAL NUMBERS OF UNITS DISTRIBUTED TO US CONSIGNEES: 040756-1, 040756-2, 10507, 10515, 10517, 10518, 10519, 10520, 10521, 10522, 10523, 10524, 10525, 10526, 10527, 10528, 10529, 10530, 10541, 10542, 10543, 10544, 10545, 10546, 10548, 10550, 10551, 10552, 10553, 10554, 10555, 10557, 10559, 10576, 10577, 10578, 10579, 10580, 10581, 10582, 10583, 10584, 10585, 10586, 10588, 10589, 10592, 10595, 10596, 10597, 10598, 10600, 10601, 10602, 10603, 10609, 10610, 10611, 10612, 10613, 10614, 10615, 10621, 10622, 10623, 10624, 10625, 10626, 10627, 10628, 10629, 10630, 10631, 10632, 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, 10685, 10686, 10687, 10688, 10701, 10702, 10703, 10704, 10705, 10706, 10707, 10708, 10709, 10710, 10711, 10712, 10713, 10714, 10715, 10716, 10717, 10718, 10719, 10725, 10726, 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, 10790, 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, 11005, 11006, 11007, 11008, 11009, 11013, 11020, 11021, 11022, 11023, 11024, 11025, 11026, 11027, 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, 11111, 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, 12137, 12138, 12141, 12142, 12143, 12145, 12146, 12147, 12148, 12149, 12150, 12151, 12152, 12153, 12154, 12155, 12156, 12157, 12158, 12159, 12160, 12161, 12162, 12163, 12164, 12165, 12166, 12167, 12168, 12169, 12170, 12171, 12172, 12173, 12174, 12175, 12176, 12177, 12178, 12179, 12180, 12181, 12182, 12183, 12184, 12
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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