Z-0769-2017 Class II Terminated
FDA device recall Z-0769-2017 was initiated by Natus Medical Incorporated on September 16, 2016 and is designated Class II. 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 th… The recall status is terminated (terminated September 1, 2017). Affected quantity: 713 units total (403 units in US and 310 units outside US).
Recall Details
- Product Type
- Devices
- Report Date
- December 21, 2016
- Initiation Date
- September 16, 2016
- Termination Date
- September 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 713 units total (403 units in US and 310 units outside US)
Product Description
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
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.
Distribution Pattern
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).
Code Information
*************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.