Z-0769-2017Class II

Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and...

Name: Z-0769-2017 Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and...
Creator: Natus Medical Incorporated
Published: 2016-09-16
License: https://open.fda.gov/license/

Natus Medical Incorporated / initiated 2016-09-16 / Terminated / root cause: design

FDA source

Natus Medical Incorporated began a recall of Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, open bed, radiant warmer... on 2016-09-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0769-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-16
Posted: 2016-12-15
Terminated: 2017-09-01
Recalling firm: Natus Medical Incorporated
Product: 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
Product code: LBI Unit, Neonatal Phototherapy
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.
Root cause tag: design
FDA root cause: Device Design
Action: Natus sent the Urgent Recall Notification/Field Safety Notice and Customer Reply Form (DOC-021042A), dated September 16, 2016 and the Technical Bulletin (DOC-021016) to US consignees via email. The letters and technical bulletin for foreign consignees was sent via email to the appropriate Natus Distribution Partner (DP) on November 7, 2016. US Customers can email the customer reply form to [email protected] or fax to (847-949-6031). US Customers with questions can call Natus Technical Service at 888-496-2887. International customers should contact their local distributor with any questions.
Quantity in commerce: 713 units total (403 units in US and 310 units outside US)
Distribution: 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).
Product codes and lots: *************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, 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0769-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0769-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-15

Product code LBI

K103589Class IINeoblue Blanket LED Phototherapy SystemNatus Medical Incorporated / cleared 2011-05-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)