Device Recall Brilliance 64 CT System

  • Model / Serial
    Serial numbers: 4001, 4020, 4021, 9030, 9033, 9040, 9041, 9048, 9049, 9062, 9074, 9083, 9093, 9105, 9106, 9107, 9108, 9112, 9123, 9126, 9127, 9131, 9135, 9137, 9139, 9140, 9142, 9148, 9151, 9159, 9160, 9162, 9163, 9166, 9171, 9173, 9175, 9177, 9180, 9196, 9197, 9201, 9202, 9205, 9206, 9208, 9214, 9215, 9216, 9217, 9218, 9235, 9501, 9502, 9503, 9504, 9505, 9506, 9508, 9509, 9510, 9511, 9512, 9513, 9514, 9515, 9516, 9517, 9518, 9519, 9520, 9521, 9522, 9523, 9524, 9525, 9526, 9527, 9528, 9529, 9530, 9531, 9532, 9533, 9535, 9536, 9537, 9538, 9539, 9540, 9541, 9542,9543, 9544, 9545, 9546, 9547, 9548, 9549, 9550, 9551, 9552, 9553, 9554, 9555, 9556, 9557, 9558, 9559, 9560, 9561, 9562, 9563, 9564, 9565, 9566, 9567, 9568, 9569, 9570, 9571, 9572, 9573, 9574, 9575, 9576, 9577, 9578, 9579, 9580, 9581, 9582, 9583, 9584, 9585, 9586, 9587, 9588, 9589, 9590, 9591, 9592, 9593, 9594, 9595, 9596, 9597, 9598, 9599, 9600, 9601, 9602, 9603, 9604, 9605, 9606, 9607, 9608, 9610, 9611, 9612, 9613, 9614, 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9782, 9783, 9784, 9785, 9786, 9787, 9788, 9789, 9790, 9791, 9792, 9793, 9794, 9795, 9796, 9797, 9798, 9799, 9800, 9801, 9802, 9803, 9804, 9805, 9806, 9807, 9808, 9809, 9810, 9811, 9812, 9813, 9814, 9815, 9816, 9817, 9818, 9819, 9820, 9821, 9822, 9823, 9824, 9825, 9826, 9827, 9828, 9829, 9830, 9831, 9832, 9833, 9834, 9835, 9836, 9837, 9838, 9839, 9840, 9841, 9842, 9843, 9844, 9845, 9846, 9847, 9848, 9850, 9851, 9852, 9853, 9854, 9855, 9856, 9857, 9858, 9859, 9860, 9861, 9862, 9864, 9865, 9866, 9867, 9868, 9869, 9870, 9871, 9872, 9873, 9874, 9875, 9876, 9877, 9878, 9879, 9880, 9881, 9882, 9883, 9884, 9885, 9886, 9887, 9888, 9889, 9890, 9891, 9892, 9893, 9894, 9895, 9897, 9898, 9900, 9901, 9902, 9903, 9904, 9905, 9906, 9907, 9908, 9909, 9910, 9911, 9912, 9913, 9914, 9915, 9916, 9917, 9918, 9919, 9920, 9921, 9922, 9923, 9924, 9925, 9926, 9927, 9929, 9930, 9931, 9932, 9933, 9934, 9935, 9936, 9937, 9938, 9940, 9941, 9942, 9946, 9947, 9948, 9950, 9951, 9953, 9954, 9955, 9956, 9958, 9960, 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95116, 95117, 95118, 95119, 95120, 95121, 95122, 95123, 95124, 95125, 95126, 95127, 95128, 95129, 95130, 95131, 95132, 95133, 95134, 95135, 95136, 95137, 95138, 95139, 95140, 95141, 95142, 95143, 95144, 95145, 95146, 95147, 95148, 95149, 95150, 95151, 95152, 95153, 95154, 95155, 95156, 95157, 95158, 95159, 95160, 95161, 95163, 95164, 95165, 95166, 95167, 95168, 95169, 95170, 95171, 95172, 95173, 95174, 95175, 95176, 95177, 95178, 95179, 95180, 95181, 95182, 95183, 95184, 95185, 95186, 95187, 95188, 95189, 95190, 95191, 95192, 95193, 95194, 95195, 95196, 95197, 95198, 95199, 95200, 95201, 95202, 95203, 95204, 95205, 95206, 95207, 95208, 95209, 95210, 95211, 95212, 95213, 95214, 95215, 95216, 95217, 95218, 95219, 95220, 95221, 95222, 95223, 95224, 95225, 95226, 95227, 95228, 95229, 95231, 95232, 95233, 95234, 95235, 95236, 95237, 95238, 95239, 95240, 95241, 95242, 95243, 95244, 95245, 95246, 95247, 95249, 95250, 95251, 95252, 95253, 95254, 95255, 95256, 95257, 95258, 95259, 95260, 95261, 95262, 95263, 95264, 95265, 95266, 95267, 95268, 95269, 95270, 95271, 95272, 95273, 95274, 95275, 95276, 95277, 95278, 95279, 95280, 95281, 95282, 95283, 95284, 95285, 95286, 95287, 95288, 95289, 95290, 95291, 95292, 95293, 95294, 95295, 95296, 95297, 95298, 95299, 95300, 95301, 95302, 95303, 95304, 95305, 95307, 95308, 95309, 95310, 95311, 95312, 95313, 95314, 95315, 95316, 95317, 95318, 95319, 95320, 95321, 95322, 95323, 95324, 95325, 95326, 95327, 95328, 95329, 95330, 95331, 95332, 95333, 95334, 95335, 95336, 95337, 95338, 95339, 95340, 95341, 95342, 95343, 95344, 95345, 95346, 95347, 95348, 95349, 95350, 95351, 95352, 95353, 95354, 95355, 95356, 95357, 95358, 95359, 95360, 95361, 95362, 95363, 95364, 95365, 95366, 95367, 95368, 95369, 95370, 95371, 95373, 95374, 95375, 95376, 95377, 95378, 95379, 95380, 95381, 95382, 95383, 95384, 95385, 95386, 95387, 95388, 95389, 95390, 95391, 95393, 95394, 95395, 95397, 95398, 95399, 95400, 95401, 95402, 95403, 95404, 95405, 95406, 95407, 95408, 95409, 95410, 95411, 95412, 95413, 95414, 95415, 95416, 95417, 95418, 95419, 95420, 95421, 95422, 95423, 95424, 95425, 95426, 95427, 95428, 95429, 95430, 95431, 95432, 95433, 95434, 95435, 95436, 95437, 95438, 95439, 95440, 95441, 95443, 95444, 95445, 95446, 95447, 95448, 95449, 95450, 95451, 95452, 95453, 95454, 95455, 95456, 95457, 95458, 95459, 95460, 95461, 95462, 95463, 95464, 95465, 95466, 95467, 95468, 95469, 95470, 95471, 95472, 95473, 95474, 95475, 95476, 95477, 95478, 95479, 95480, 95481, 95482, 95483, 95484, 95485, 95486, 95487, 95488, 95489, 95490, 95491, 95492, 95493, 95494, 95495, 95496, 95497, 95498, 95499, 95500, 95501, 95502, 95503, 95504, 95505, 95506, 95507, 95508, 95509, 95510, 95511, 95512, 95513, 95514, 95515, 95516, 95517, 95518, 95519, 95520, 95521, 95522, 95523, 95524, 95525, 95526, 95527, 95528, 95529, 95530, 95531, 95532, 95533, 95534, 95535, 95536, 95537, 95538, 95539, 95540, 95541, 95542, 95543, 95544, 95545, 95546, 95547, 95548, 95549, 95550, 95551, 95552, 95553, 95554, 95555, 95556, 95557, 95558, 95559, 95560, 95561, 95562, 95563, 95564, 95565, 95566, 95568 5569, 95570, 95572, 95573, 95574, 95575, 95577, 95578, 95579, 95580, 95581, 95582, 95583, 95584, 95585, 95586, 95587, 95588, 95589, 95590, 95591, 95592, 95593, 95594, 95595, 95596, 95597, 95598, 95599, 95600, 95601, 95602, 95603, 95604, 95605, 95606, 95607, 95608, 95609, 95610, 95611, 95612, 95613, 95614, 95615, 95616, 95617, 95618, 95619, 95620, 95621, 95622, 95623, 95624, 95625, 95626, 95627, 95628, 95629, 95630, 95631, 95632, 95633, 95634, 95635, 95636, 95637, 95638, 95639, 95640, 95641, 95642, 95643, 95644, 95645, 95646, 95647, 95648, 95649, 95650, 95651, 95652, 95653, 95654, 95655, 95656, 95657, 95658, 95659, 95660, 95661, 95662, 95663, 95664, 95665, 95666, 95667, 95668, 95669, 95670, 95671, 95672, 95673, 95674, 95675, 95676, 95677, 95678, 95679, 95680, 95681, 95682, 95683, 95684, 95685, 95686, 95687, 95688, 95689, 95690, 95691, 95692, 95693, 95694, 95695, 95696, 95697 and 410249.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution. US nationwide, including Puerto Rico, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Equatorial Guinea, Finland, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam & Yemen.
  • Product Description
    Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Model #728231, Serial Numbers: 4003, 9875, and 90135.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide (USA) including the states of: IN, MI, MO, NY, OH, and OR and the countries of Germany, Israel and Netherlands.
  • Product Description
    Brilliance 64 CT (Computed Tomography) System, 510 (k) #K033326, Model #728231, Serial Numbers: 4003, 9875, and 90135. The recalled CT systems are equipped with Software Version 3.5 Beta 2. || Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
  • Manufacturer