FDAFDA · Food and drugs·Recall number Z-0409-2016
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.
Published December 16, 2015 · Recall initiated: March 3, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Multiple software defects which could impact the performance or reliability of the system. These impacts include, but are not limited to: error messages which prevent operation, incorrect scan region, couch movement failure, inaccurate CTDI reporting, image artifacts, lost images. There is a risk of misdiagnosis.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Distributor
- 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.
- Lot
- 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, 1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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