Rappel de Device Recall Brilliance 64 CT System

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, 9615, 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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, 9961, 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10158, 10159, 10160, 10161, 10162,10163, 10164, 10165, 10166, 10167, 10168, 10169, 10170, 10171, 10172, 10173, 10174, 10175, 10176, 10177, 10178, 10179, 10180, 10181, 10182, 10183, 10184, 10185, 10186, 10187, 10188, 10189, 10190, 10191, 10192, 10193, 10195, 10196, 10197, 10198, 10200, 10203, 10204, 10206, 10207, 10208, 10209, 10210, 10211, 10213, 10216, 10218, 10221, 10222, 10223, 10224, 10225, 10226, 10229, 10230, 10232, 10233, 10234, 10237, 10238, 10239, 10240, 10241, 10242, 10243, 10244, 10245, 10246, 10247, 10248, 10250, 10252, 10255, 10256, 10257, 10258, 10259, 10260, 10262, 10263, 10264, 10267, 10268, 10270, 10271, 10272, 10273, 10274, 10275, 10276, 10277, 10278, 10279, 10280, 10281, 10282, 10283, 10284, 10285, 10286, 10287, 10288, 10291, 10293, 10294, 10295, 10296, 10297, 10298, 10299, 10300, 10301, 10302, 10303, 10304, 10305, 10307, 10308, 10309, 10311, 10312, 10313, 10315, 10316, 10318, 10319, 10320, 10326, 10330, 10332, 10333, 10334, 10335, 10336, 10337, 10338, 10339, 10341, 10342, 10343, 10344, 10345, 10346, 10347, 10348, 10349, 10350, 10351, 10352, 10353, 10354, 10355, 10356, 10357, 10358, 10359, 10360, 10361, 10362, 10363, 10364, 10365, 10366, 10367, 10368, 10369, 10370, 10371, 10372, 10373, 10374, 10376, 10377, 10380, 10381, 10382, 10383, 10384, 10385, 10386, 10387, 10388, 10389, 10390, 10391, 10392, 10393, 10394, 10395, 10396, 10397, 10398, 10399, 10400, 10401, 10402, 10403, 10404, 10406, 10407, 10408, 10409, 10410, 10411, 10412, 10413, 10414, 10417, 10418, 10420, 10421, 10422, 10423, 10424, 10425, 10426, 10427, 10428, 10429, 10430, 10431, 10432, 10433, 10434, 10436, 10437, 10438, 10439, 29002, 29003, 29005, 29032, 29035, 29045, 29056, 29066, 29092, 29107, 64015, 64173, 65006, 85210, 90029, 90030, 90031, 90033, 90036, 90037, 90042, 90045, 90050, 90054, 90055, 90057, 90060, 90062, 90063, 90066, 90070, 90072, 90073, 90074, 90077, 90078, 90080, 90081, 90082, 90084, 90085, 90086, 90087, 90089, 90091, 90092, 90094, 90096, 90097, 90098, 90099, 90100, 90105, 90107, 90117, 90118, 90119, 90120, 90123, 90124, 90129, 90131, 90132, 90135, 90136, 90137, 90139, 90140, 90141, 90143, 90147, 90151, 90152, 90153, 90154, 90156, 90159, 90160, 90161, 90162, 90163, 90167, 90168, 90170, 90175, 90177, 90182, 90205, 90218, 91003, 92029, 94134, 95003, 95008, 95009, 95011, 95012, 95013, 95014, 95015, 95016, 95017, 95018, 95019, 95020, 95021, 95022, 95023, 95024, 95025, 95026, 95029, 95030, 95031, 95032, 95033, 95034, 95035, 95036, 95037, 95038, 95039, 95040, 95041, 95042, 95043, 95044, 95045, 95046, 95047, 95048, 95049, 95050, 95051, 95052, 95053, 95055, 95056, 95057, 95058, 95059, 95060, 95061, 95062, 95063, 95064, 95065, 95066, 95067, 95068, 95069, 95071, 95072, 95073, 95074, 95075, 95076, 95077, 95078, 95079, 95080, 95081, 95082, 95083, 95084, 95085, 95086, 95087, 95088, 95089, 95090, 95091, 95092, 95093, 95094, 95095, 95096, 95097, 95098, 95099, 95100, 95101, 95102, 95103, 95104, 95105, 95106, 95107, 95108, 95109, 95110, 95111, 95112, 95113, 95114, 95116, 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Radiology Devices

2

No

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.

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.