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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74587

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 28, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Natus Medical Incorporated

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0770-2017
Recall number
Z-0770-2017
Initiated
October 28, 2016
Classification
Class II
Status
Terminated
Quantity
2619 units (1925 units in the US and 694 units OUTSIDE the US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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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.

Distribution pattern

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).