Devices

Natus neoBLUE blanket LED Phototherapy System

  • Modelo / Serial
    *************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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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, 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  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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).
  • Descripción del producto
    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
  • Manufacturer
    Natus Medical Incorporated
  • 1 Event

Fabricante

Natus Medical Incorporated
  • Dirección del fabricante
    Natus Medical Incorporated, 5900 1st Ave S, Seattle WA 98108-3248
  • Empresa matriz del fabricante (2017)
    Natus Medical Incorporated
  • Source
    USFDA

3 dispositivos con un nombre similar

Más información acerca de la data acá

Device Recall Natus neoBLUE blanket LED Phototherapy system
  • Modelo / Serial
    None
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    distributed worldwide
  • Descripción del producto
    Natus neoBLUE blanket LED Phototherapy system which includes the following items: || 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 || 007302 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
  • Manufacturer
    Natus Medical Incorporated
Natus neoBLUE Blanket LED Phototherapy System - fiberoptic pads
  • Modelo / Serial
  • Descripción del producto
    Natus neoBLUE Blanket LED Phototherapy System - fiberoptic pads, Natus Medical Incorporated
  • Manufacturer
    Equip Medical Pte Ltd
Natus neoBLUE blanket LED Phototherapy system
  • Modelo / Serial
    ************SERIAL NUMBERS OF UNITS DISTRIBUTED TO US GOVERMENT ACCOUNTS  000089, 000104, 000128, 001342, 001364, 001367, 001371, 001372, 001373, 001374, 001375, 001376, 001377, 001391, 001392, 001393, 001394, 001441, 001442, 001455, 001456, 001463, 001495, 001496, 001497, 001878, 001893, 001912, 001915, 001992, 001993, 002040, 002041, 002165, 002166, 002167, 002168, 002289, 002290, 002291, 002292, 002320, 002462, 002463, 002762, 002763, 002766, 002860, 002870, 002873, 002888, 003594, 003595, 003600, 003604, 003632, 003633, and 003893.  ***********SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US  ..000284, ..000287, ..000297, ..000299, ..000310, ..000324, ..000328, ..000365, .000301, .000313, .000321, .000322, .000323, .000352, .000415, .000419, .000420, .000426, .000427, .000435, .000445, .000449, .000467, .000483, .000508, .000518, .000523, .000531, .000541, .000581, .000651, .000670, .000695, .000696, .000697, .000698, 000030, 000031, 000032, 000033, 000035, 000036, 000039, 000041, 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R002390, and R002414.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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).
  • Descripción del producto
    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