CLASS II Device recall · Reported 21 Dec 2016 · FDA Enforcement Report

Updated Natus neoBLUE blanket LED Phototherapy Systems recalled

Natus Medical is recalling Updated Natus neoBLUE blanket LED Phototherapy Systems, distributed nationwide in the US. The recall was initiated on 16 Sep 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes*************Serial Numbers of Units distributed in the US ************** 004329, 004330, 004349, 004360, 004361, 004362, 004363, 004364, 004365, 004366, 004367, 004369, 004370, 004371, 004417, 004421, 004426, 004436, 004437, 004443, 004448, 004449, 004454, 004456, 004473, 004481, 004488, 004490, 004494, 004495, 004502, 004507, 004517, 004523, 004525, 004526, 004527, 004528, 004530, 004533, 004539, 004541, 004544, 004545, 004546, 004548, 004552, 004553, 004554, 004555, 004556, 004557, 004558, 004567, 004568, 004573, 004578, 004581, 004582, 004584, 004588, 004591, 004602, 004608, 004630, 004632, 004637, 004640, 004647, 004659, 004667, 004668, 004670, 004672, 004673, 004677, 004678, 004679, 004681, 004683, 004684, 004685, 004686, 004693, 004694, 004696, 004700, 004706, 004707, 004708, 004709, 004710, 004711, 004712, 004713, 004714, 004715, 004716, 004717, 004718, 004719, 004720, 004721, 004722, 004723, 004724, 004725, 004726, 004727, 004728, 004729, 004730, 004731, 004732, 004733, 004734, 004735, 004736, 004737, 004738, 004739, 004740, 004741, 004742, 004743, 004745, 004746, 004747, 004749, 004750, 004753, 004754, 004756, 004757, 004760, 004761, 004762, 004763, 004764, 004766, 004767, 004768, 004771, 004772, 004773, 004774, 004775, 004776, 004777, 004778, 004779, 004780, 004781, 004782, 004783, 004784, 004785, 004787, 004788, 004789, 004790, 004791, 004793, 004794, 004795, 004796, 004797, 004798, 004800, 004801, 004802, 004803, 004804, 004805, 004806, 004807, 004808, 004810, 004811, 004812, 004814, 004815, 004816, 004818, 004819, 004820, 004822, 004823, 004824, 004825, 004826, 004827, 004828, 004829, 004830, 004831, 004832, 004833, 004834, 004835, 004836, 004837, 004838, 004839, 004840, 004841, 004842, 004843, 004844, 004845, 004846, 004847, 004848, 004849, 004850, 004851, 004852, 004853, 004854, 004855, 004856, 004857, 004858, 004859, 004860, 004861, 004862, 004863, 004864, 004865, 004866, 004867, 004868, 004869, 004870, 004871, 004872, 004873, 004874, 004876, 004877, 004878, 004879, 004880, 004881, 004882, 004884, 004885, 004886, 004887, 004888, 004890, 004891, 004893, 004894, 004895, 004896, 004897, 004899, 004900, 004901, 004902, 004903, 004904, 004905, 004906, 004907, 004909, 004910, 004997, 004998, 004999, 005007, 005008, 005009, 005010, 005011, 005012, 005013, 005014, 005015, 005016, 005017, 005018, 005019, 005020, 005021, 005022, 005023, 005024, 005025, 005026, 005027, 005028, 005029, 005030, 005031, 005032, 005033, 005034, 005035, 005036, 005037, 005039, 005040, 005041, 005042, 005043, 005044, 005045, 005046, 005047, 005048, 005049, 005050, 005051, 005052, 005053, 005054, 005055, 005056, 005057, 005058, 005059, 005060, 005061, 005062, 005063, 005064, 005065, 005066, 005067, 005068, 005069, 005070, 005071, 005072, 005073, 005074, 005075, 005076, 005077, 005078, 005079, 005080, 005081, 005082, 005083, 005084, 005085, 005086, 005087, 005088, 005089, 005090, 005091, 005092, 005093, 005094, 005095, 005096, 005097, 005098, 005099, 005100, 005101, 005103, 005104, 005105, 005106, 005107, 005108, 005112, 005113, 005115, 005117, 005118, 005119, 005120, 005121, 005122, 005123, 005124, 005125, 005128, 005136, 005137, 005138, 005139, 005140, 005141, 005142, 005143, 005144, 005145, 005146, 005147, 005148, 005149, 005150, 005151, 005152, and 005153. *************Serial Numbers of Units distributed in the US ************** 004283, 004284, 004285, 004286, 004287, 004288, 004290, 004291, 004292, 004293, 004294, 004295, 004296, 004298, 004299, 004302, 004303, 004305, 004306, 004307, 004308, 004309, 004310, 004312, 004313, 004314, 004315, 004316, 004319, 004320, 004321, 004322, 004325, 004326, 004327, 004328, 004332, 004333, 004334, 004335, 004337, 004338, 004339, 004340, 004341, 004343, 004344, 004345, 004347, 004348, 004350, 004351, 004353, 004354, 004355, 004356, 004357, 004359, 004372, 004373, 004374, 004375, 004379, 004380, 004381, 004382, 004383, 004384, 004385, 004386, 004388, 004389, 004390, 004391, 004392, 004393, 004394, 004395, 004396, 004397, 004399, 004400, 004401, 004402, 004403, 004404, 004405, 004406, 004408, 004411, 004412, 004413, 004414, 004415, 004416, 004418, 004419, 004420, 004422, 004423, 004424, 004425, 004427, 004428, 004430, 004431, 004432, 004433, 004439, 004440, 004442, 004445, 004446, 004447, 004450, 004451, 004452, 004453, 004455, 004457, 004458, 004459, 004460, 004462, 004463, 004464, 004465, 004466, 004467, 004468, 004469, 004471, 004472, 004474, 004475, 004476, 004477, 004478, 004479, 004480, 004484, 004485, 004486, 004489, 004491, 004492, 004496, 004497, 004498, 004499, 004500, 004501, 004503, 004504, 004505, 004508, 004510, 004511, 004512, 004513, 004514, 004515, 004516, 004518, 004519, 004520, 004521, 004522, 004524, 004531, 004532, 004536, 004542, 004543, 004549, 004551, 004565, 004569, 004570, 004571, 004572, 004574, 004575, 004576, 004577, 004585, 004587, 004589, 004590, 004592, 004593, 004594, 004596, 004597, 004598, 004599, 004600, 004601, 004604, 004605, 004606, 004609, 004610, 004611, 004612, 004613, 004614, 004615, 004616, 004617, 004618, 004619, 004620, 004621, 004622, 004623, 004624, 004625, 004626, 004628, 004629, 004631, 004633, 004634, 004635, 004638, 004639, 004641, 004642, 004643, 004644, 004645, 004646, 004648, 004649, 004650, 004651, 004652, 004653, 004655, 004656, 004657, 004658, 004660, 004662, 004663, 004664, 004665, 004666, 004669, 004671, 004674, 004675, 004680, 004682, 004688, 004689, 004690, 004692, 004695, 004697, 004698, 004699, 004701, 004702, 004703, 004704, 004705, 004744, 004748, 004751, 004752, 004755, 004758, 004765, 004769, 004770, 004792, 004799, 004809, 004813, 004817, 004821, 004875, 004889, 004898, 004908, 005102, 005111, 005114, 005116, 005126, 005127, 005129, 005130, 005131, 005132, 005133, 005134, 005135, 005154, 005155, 005239, 005240, 005241, 4317, 4323, 4324, 4368, and 4377.

Quantity recalled713 units total (403 units in US and 310 units outside US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0769-2017
FDA event ID: 75228
Recalling firm: Natus Medical, Seattle, WA
Classification: Class II
Status: Terminated
Recall initiated: 16 Sep 2016
FDA classified: 15 Dec 2016
Reported: 21 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

16 Sep 2016	Recall initiated by company
15 Dec 2016	Classified by FDA	+90 days
21 Dec 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The firm sent the Technical Bulletin to consignees who received the reliability updated neoBLUE blanket LED Phototherapy Systems between March 2016 to August 2016. The reliability update to prevent the early failure of the fiberoptic pads experienced by some customers on older systems. These failures on previous systems involved discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, open bed, radiant warmer, incubator, or while holding the infant. Affected systems including: 1) Updated light boxes (serial number xxxx004283 or greater) have protection built in to turn off the device if an overheat condition is detected. 2) Updated fiberoptic blankets (Lot Nxxxx16-xx or greater) have an improved fiberoptic cable end to reduce the degradation and increase its useful life. Affected Part Numbers and Description: 006244 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 007302 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

Where it was distributed

Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, ND, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, WV and Puerto Rico. , and to the countries of : Argentina, Austria, Canada, Chile, China, Denmark, Dominican Republic, Finland, France, Germany, Hong Kong, Hungary, Indonesia, Italy, Latvia, Malaysia, Namibia, Paraguay, Poland, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Taiwan, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, and Virgin Islands (British).

Nationwide Alabama Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine

Questions about this recall

Why was it recalled?

Which lots are affected?

*************Serial Numbers of Units distributed in the US ************** 004329, 004330, 004349, 004360, 004361, 004362, 004363, 004364, 004365, 004366, 004367, 004369, 004370, 004371, 004417, 004421, 004426, 004436, 004437, 004443, 004448, 004449, 004454, 004456, 004473, 004481, 004488, 004490, 004494, 004495, 004502, 004507, 004517, 004523, 004525, 004526, 004527, 004528, 004530, 004533, 004539, 004541, 004544, 004545, 004546, 004548, 004552, 004553, 004554, 004555, 004556, 004557, 004558, 004567, 004568, 004573, 004578, 004581, 004582, 004584, 004588, 004591, 004602, 004608, 004630, 004632, 004637, 004640, 004647, 004659, 004667, 004668, 004670, 004672, 004673, 004677, 004678, 004679, 004681, 004683, 004684, 004685, 004686, 004693, 004694, 004696, 004700, 004706, 004707, 004708, 004709, 004710, 004711, 004712, 004713, 004714, 004715, 004716, 004717, 004718, 004719, 004720, 004721, 004722, 004723, 004724, 004725, 004726, 004727, 004728, 004729, 004730, 004731, 004732, 004733, 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004877, 004878, 004879, 004880, 004881, 004882, 004884, 004885, 004886, 004887, 004888, 004890, 004891, 004893, 004894, 004895, 004896, 004897, 004899, 004900, 004901, 004902, 004903, 004904, 004905, 004906, 004907, 004909, 004910, 004997, 004998, 004999, 005007, 005008, 005009, 005010, 005011, 005012, 005013, 005014, 005015, 005016, 005017, 005018, 005019, 005020, 005021, 005022, 005023, 005024, 005025, 005026, 005027, 005028, 005029, 005030, 005031, 005032, 005033, 005034, 005035, 005036, 005037, 005039, 005040, 005041, 005042, 005043, 005044, 005045, 005046, 005047, 005048, 005049, 005050, 005051, 005052, 005053, 005054, 005055, 005056, 005057, 005058, 005059, 005060, 005061, 005062, 005063, 005064, 005065, 005066, 005067, 005068, 005069, 005070, 005071, 005072, 005073, 005074, 005075, 005076, 005077, 005078, 005079, 005080, 005081, 005082, 005083, 005084, 005085, 005086, 005087, 005088, 005089, 005090, 005091, 005092, 005093, 005094, 005095, 005096, 005097, 005098, 005099, 005100, 005101, 005103, 005104, 005105, 005106, 005107, 005108, 005112, 005113, 005115, 005117, 005118, 005119, 005120, 005121, 005122, 005123, 005124, 005125, 005128, 005136, 005137, 005138, 005139, 005140, 005141, 005142, 005143, 005144, 005145, 005146, 005147, 005148, 005149, 005150, 005151, 005152, and 005153. *************Serial Numbers of Units distributed in the US ************** 004283, 004284, 004285, 004286, 004287, 004288, 004290, 004291, 004292, 004293, 004294, 004295, 004296, 004298, 004299, 004302, 004303, 004305, 004306, 004307, 004308, 004309, 004310, 004312, 004313, 004314, 004315, 004316, 004319, 004320, 004321, 004322, 004325, 004326, 004327, 004328, 004332, 004333, 004334, 004335, 004337, 004338, 004339, 004340, 004341, 004343, 004344, 004345, 004347, 004348, 004350, 004351, 004353, 004354, 004355, 004356, 004357, 004359, 004372, 004373, 004374, 004375, 004379, 004380, 004381, 004382, 004383, 004384, 004385, 004386, 004388, 004389, 004390, 004391, 004392, 004393, 004394, 004395, 004396, 004397, 004399, 004400, 004401, 004402, 004403, 004404, 004405, 004406, 004408, 004411, 004412, 004413, 004414, 004415, 004416, 004418, 004419, 004420, 004422, 004423, 004424, 004425, 004427, 004428, 004430, 004431, 004432, 004433, 004439, 004440, 004442, 004445, 004446, 004447, 004450, 004451, 004452, 004453, 004455, 004457, 004458, 004459, 004460, 004462, 004463, 004464, 004465, 004466, 004467, 004468, 004469, 004471, 004472, 004474, 004475, 004476, 004477, 004478, 004479, 004480, 004484, 004485, 004486, 004489, 004491, 004492, 004496, 004497, 004498, 004499, 004500, 004501, 004503, 004504, 004505, 004508, 004510, 004511, 004512, 004513, 004514, 004515, 004516, 004518, 004519, 004520, 004521, 004522, 004524, 004531, 004532, 004536, 004542, 004543, 004549, 004551, 004565, 004569, 004570, 004571, 004572, 004574, 004575, 004576, 004577, 004585, 004587, 004589, 004590, 004592, 004593, 004594, 004596, 004597, 004598, 004599, 004600, 004601, 004604, 004605, 004606, 004609, 004610, 004611, 004612, 004613, 004614, 004615, 004616, 004617, 004618, 004619, 004620, 004621, 004622, 004623, 004624, 004625, 004626, 004628, 004629, 004631, 004633, 004634, 004635, 004638, 004639, 004641, 004642, 004643, 004644, 004645, 004646, 004648, 004649, 004650, 004651, 004652, 004653, 004655, 004656, 004657, 004658, 004660, 004662, 004663, 004664, 004665, 004666, 004669, 004671, 004674, 004675, 004680, 004682, 004688, 004689, 004690, 004692, 004695, 004697, 004698, 004699, 004701, 004702, 004703, 004704, 004705, 004744, 004748, 004751, 004752, 004755, 004758, 004765, 004769, 004770, 004792, 004799, 004809, 004813, 004817, 004821, 004875, 004889, 004898, 004908, 005102, 005111, 005114, 005116, 005126, 005127, 005129, 005130, 005131, 005132, 005133, 005134, 005135, 005154, 005155, 005239, 005240, 005241, 4317, 4323, 4324, 4368, and 4377.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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