Device Recall Brilliance 64 Computed Tomography Xray systems

Model #: 728231; Serial #s: 9009, 9029, 9033, 9037, 9038, 9043, 9045, 9051, 9052, 9056, 9058, 9064, 9065, 9067, 9068, 9070, 9072, 9073, 9075, 9086, 9089, 9092, 9104, 9105, 9106, 9107, 9108, 9112, 9120, 9139, 9151, 9152, 9156, 9190, 9243, 9259, 9502, 9503, 9504, 9507, 9508, 9511, 9512, 9515, 9516, 9522, 9525, 9526, 9529, 9530, 9531, 9533, 9534, 9545, 9547, 9550, 9551, 9556, 9561, 9564, 9572, 9577, 9580, 9584, 9591, 9594, 9596, 9598, 9603, 9606, 9607, 9608, 9612, 9613, 9614, 9618, 9620, 9624, 9625, 9626, 9628, 9630, 9633, 9634, 9635, 9639, 9640, 9641, 9642, 9646, 9648, 9650, 9655, 9663, 9666, 9667, 9672, 9676, 9678, 9685, 9686, 9690, 9691, 9692, 9694, 9695, 9697, 9700, 9705, 9706, 9709, 9713, 9716, 9726, 9729, 9732, 9735, 9736, 9738, 9740, 9750, 9751, 9752, 9753, 9754, 9757, 9759, 9760, 9761, 9775, 9777, 9780, 9781, 9788, 9790, 9793, 9794, 9802, 9805, 9809, 9811, 9812, 9821, 9823, 9826, 9830, 9833, 9835, 9843, 9846, 9855, 9857, 9860, 9861, 9866, 9869, 9870, 9873, 9875, 9876, 9878, 9879, 9881, 9882, 9885, 9888, 9889, 9890, 9894, 9895, 9902, 9906, 9910, 9916, 9917, 9918, 9924, 9936, 9937, 9938, 9942, 9948, 9951, 9954, 9960, 9961, 9965, 9966, 9968, 9969, 9974, 9975, 9978, 9980, 9982, 9985, 9992, 9993, 9994, 9999, 10001, 10005, 10014, 10018, 10026, 10030, 10031, 10035, 10036, 10037, 10041, 10045, 10046, 10051, 10054, 10065, 10067, 10070, 10072, 10079, 10080, 10085, 10086, 10094, 10095, 10096, 10098, 10103, 10111, 10112, 10113, 10120, 10122, 10125, 10141, 10148, 10190, 10194, 10200, 10202, 10203, 10211, 10224, 10256, 10263, 10291, 10292, 10310, 10332, 10353, 10359, 10363, 10365, 10370, 10371, 10372, 10373, 10380, 10381, 10386, 10388, 10413, 10417, 10424, 10426, 10473, 10486, 10505, 10513, 10527, 10535, 10561, 10570, 10645, 10651, 10655, 10673, 10686, 10733, 10743, 10773, 10776, 29005, 29007, 29016, 29018, 29025, 29027, 29035, 29037, 29053, 29054, 29068, 29097, 64015, 90031, 90047, 90062, 90063, 90128, 95003, 95008, 95022, 95057, 95058, 95068, 95149, 95197, 95210, 95348, 95357, 95377, 95392, 95403, 95811, 95341A, 9851T, 9172.

Radiology Devices

2

No

Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.