Brilliance 64 Computed Tomography X-ray systems is recall: Software Issue

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product

Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray…

Recalling firm

Philips Medical Systems (Cleveland) Inc

Quantity

318 units

Distribution

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.

Recall date

August 17, 2016

Classification

Class II

Status

Terminated

Agency

FDA (device)