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, 9616, 9617, 9618, 9619, 9620, 9621, 9622, 9623, 9624, 9625, 9626, 9627, 9628, 9629, 9630, 9631, 9632, 9633, 9634, 9635, 9636, 9637, 9638, 9639, 9640, 9641, 9642, 9643, 9644, 9645, 9646, 9647, 9648, 9649, 9650, 9651, 9652, 9653, 9654, 9655, 9656, 9658, 9659, 9660, 9661, 9662, 9663, 9664, 9665, 9666, 9667, 9668, 9669, 9670, 9671, 9672, 9673, 9674, 9675, 9676, 9677, 9678, 9679, 9680, 9681, 9682, 9683, 9684, 9685, 9686, 9687, 9688, 9689, 9690, 9691, 9692, 9693, 9694, 9695, 9696, 9697, 9698, 9699, 9700, 9701, 9702, 9703, 9704, 9705, 9706, 9707, 9708, 9709, 9710, 9711, 9712, 9713, 9714, 9715, 9716, 9717, 9718, 9719, 9720, 9721, 9722, 9723, 9724, 9725, 9726, 9727, 9728, 9729, 9730, 9731, 9732, 9733, 9734, 9735, 9736, 9737, 9738, 9739, 9740, 9741, 9742, 9743, 9744, 9745, 9746, 9747, 9748, 9749, 9750, 9751, 9752, 9753, 9754, 9755, 9756, 9757, 9758, 9759, 9760, 9761, 9762, 9763, 9764, 9765, 9766, 9767, 9768, 9769, 9770, 9771, 9772, 9773, 9774, 9775, 9776, 9777, 9778, 9779, 9780, 9781, 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, 9961, 9962, 9963, 9965, 9968, 9969, 9970, 9971, 9972, 9974, 9975, 9976, 9977, 9978, 9979, 9980, 9981, 9983, 9984, 9985, 9986, 9987, 9989, 9993, 9994, 9995, 9996, 9997, 9999, 10000, 10001, 10002, 10003, 10004, 10007, 10009, 10011, 10012, 10013, 10014, 10015, 10016, 10018, 10021, 10023, 10027, 10028, 10032, 10033, 10034, 10035, 10036, 10037, 10039, 10040, 10041, 10042, 10044, 10045, 10046, 10047, 10048, 10050, 10051, 10052, 10053, 10054, 10057, 10058, 10065, 10066, 10067, 10070, 10072, 10076, 10077, 10078, 10079, 10080, 10081, 10084, 10085, 10086, 10087, 10090, 10091, 10092, 10094, 10095, 10096, 10098, 10099, 10100, 10101, 10102, 10103, 10105, 10106, 10107, 10108, 10110, 10111, 10112, 10113, 10114, 10115, 10116, 10117, 10118, 10119, 10120, 10121, 10122, 10123, 10124, 10125, 10126, 10127, 10128, 10129, 10130, 10131, 10132, 10133, 10134, 10135, 10136, 10137, 10138, 10139, 10140, 10141, 10142, 10143, 10144, 10145, 10146, 10147, 10148, 10149, 10150, 10151, 10152, 10153, 10154, 10155, 10156, 10157, 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, 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.

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.