Events

Recall of Natus neoBLUE blanket LED Phototherapy system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Natus Medical Incorporated.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74587
  • Event Risk Class
    Class 2
  • Event Number
    Z-0770-2017
  • Event Initiated Date
    2016-10-28
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147989
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Unit, neonatal phototherapy - Product Code LBI
  • Reason
    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.
  • 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. Natus plans to notify their international customers on December 2, 2016. Customers 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. The 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. Natus 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. Natus 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). Please contact Natus Quality_Programs@natus.com if you have any further questions. Please call (800) 426-0353.

Device

Natus neoBLUE blanket LED Phototherapy system
  • Model / Serial
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004238, 004240, 004241, 004246, 004247, 004248, 004249, 004250, 004251, 004252, 004253, 004254, 004255, 004256, 004257, 004258, 004259, 004260, 004261, 004263, 004264, 004268, 004269, 004270, 004271, 004273, 1215R002299, 2298, 2300, 2302, 2303, 2304, NR002392, R002300, R002301, 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, 000686, 000691, 000692, 000701, 000706, 000707, 000713, 000714, 000716, 000721, 000723, 000724, 000725, 000726, 000728, 000729, 000737, 000738, 000739, 000746, 000747, 000748, 000757, 000764, 000765, 000777, 000778, 000779, 000780, 000840, 000885, 000886, 000887, 000888, 000889, 000890, 000896, 000897, 000918, 000919, 000920, 000931, 000932, 000933, 000934, 000956, 000975, 000977, 000980, 000994, 000995, 000996, 000997, 001001, 001002, 001007, 001008, 001009, 001014, 001015, 001016, 001017, 001049, 001051, 001052, 001053, 001054, 001055, 001057, 001060, 001061, 001062, 001063, 001064, 001065, 001066, 001069, 001070, 001071, 001072, 001073, 001074, 001075, 001076, 001077, 001078, 001079, 001080, 001081, 001082, 001083, 001084, 001089, 001090, 001091, 001092, 001093, 001097, 001098, 001099, 001100, 001101, 001102, 001114, 001172, 001178, 001179, 001187, 001188, 001192, 001193, 001194, 001198, 001244, 001245, 001246, 001247, 001248, 001250, 001251, 001320, 001325, 001326, 001328, 001332, 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.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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).
  • Product Description
    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
  • Manufacturer
    Natus Medical Incorporated

Manufacturer

Natus Medical Incorporated
  • Manufacturer Address
    Natus Medical Incorporated, 5900 1st Ave S, Seattle WA 98108-3248
  • Manufacturer Parent Company (2017)
    Natus Medical Incorporated
  • Source
    USFDA