{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "147989", "product_res_number": "Z-0770-2017", "event_date_initiated": "2016-10-28", "event_date_created": "2016-12-15", "recall_status": "Terminated", "event_date_terminated": "2021-01-15", "res_event_number": "74587", "product_code": "LBI", "k_numbers": [ "K103589" ], "product_description": "Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia.\n\n006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad\n006254 neoBLUE blanket LED Light Box\n006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad\n007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR\n007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR\n007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK\n007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK\n007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS\n007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS", "code_info": "************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, 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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, 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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.", "firm_fei_number": "3018859", "recalling_firm": "Natus Medical Incorporated", "address_1": "5900 1st Ave S", "city": "Seattle", "state": "WA", "postal_code": "98108-3248", "reason_for_recall": "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.", "root_cause_description": "Device Design", "action": "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.\n\nNatus plans to notify their international customers on December 2, 2016. \n\nCustomers 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.\n\nThe 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.\n\nNatus 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. \n\nNatus 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).\n\nPlease contact Natus Quality_Programs@natus.com if you have any further questions. Please call (800) 426-0353.", "product_quantity": "2619 units (1925 units in the US and 694 units OUTSIDE the US)", "distribution_pattern": "Worldwide Distribution - USA (nationwide) Distribution and to the countries of : including American Samoa and Guam, and in the following countries:\nAlbania, 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).", "openfda": { "k_number": [ "K854122", "K974830", "K011549", "K810953", "K934946", "K110550", "K160238", "K910571", "K902749", "K010495", "K071828", "K163526", "K120168", "K791114", "K200031", "K971256", "K834335", "K850181", "K072097", "K120820", "K882291", "K771025", "K160745", "K834430", "K760872", "K131196", "K892940", "K083179", "K830200", "K883779", "K901987", "K070180", "K884133", "K903445", "K172656", "K940996", "K142332", "K984589", "K190899", "K093618", "K103828", "K111547", "K022196", "K113206", "K931965", "K210289", "K040853", "K954611", "K090192", "K840454", "K103735", "K002414", "K160305", "K850599", "K182178", "K243372", "K813188", "K962612", "K802702", "K971601", "K873700", "K912908", "K051869", "K053568", "K103589", "K170585", "K251308", "K021531", "K832298", "K991627", "K894129" ], "registration_number": [ "1000312377", "3002807523", "3012348048", "3000279201", "3014128880", "1000617661", "3014220748", "9612197", "1419937", "9617277", "3005934741", "3013424071", "3005652389", "1625392", "2510954", "3006179052", "1066270", "2133810", "1930027", "3013919653", "3042972073", "3007734888", "3036470679", "3010611950", "9611451", "2085602", "1000122810" ], "fei_number": [ "1000312377", "3002807523", "3012348048", "3000203066", "3000279201", "3014128880", "1000617661", "3002807554", "3014220748", "1419937", "3005934741", "3013424071", "3004846435", "2510954", "3006179052", "1930027", "3013919653", "3042972073", "3007734888", "3000210616", "3036470679", "3010611950", "3000957797", "3002806988", "1000058335", "1000122810", "3003190524" ], "device_name": "Unit, Neonatal Phototherapy", "medical_specialty_description": "General Hospital", "regulation_number": "880.5700", "device_class": "2" } } ] }