Brilliance CT Big Bore Oncology recall
Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT Big Bore…
Why was Brilliance CT Big Bore Oncology recalled?
There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with protocols using a Rotation Time of 0.4 seconds.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
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?
System Code #728243, Serial #: 7040, 7083, 7087, 7123, 7124, 7133, 7170, 7178, 7204, 7231, 7273, 7328, 7365, 7370, 7395, 7434, 7467, 7596, 7612, 7775, 7794, 7795, 7840, 7841, 7842, 7843, 7846, 7847, 7848, 7849, 7850, 7851, 7852, 7854, 7855, 7856, 7857, 7858, 7860, 7861, 7863, 7864, 7865, 7866, 7867, 7868, 7871, 7872, 7873, 7875, 7876, 7877, 7881, 7883, 7884, 7885, 7886, 7889, 7890, 7891, 7892, 7893, 7895, 7896, 7898, 7900, 7901, 7902, 7904, 7905, 7907, 7908, 7909, 7910, 7911, 7912, 7914, 7915, 7916, 7918, 7920, 7921, 7923, 7924, 7926, 7927, 7928, 7930, 7931, 7932, 7934, 7935, 7936, 7937, 7938, 7940, 7941, 7942, 7943, 7944 and 7945. System Code #728244, Serial #: 7121, 7271, 7764, 7844, 7845, 7853, 7859, 7862, 7869, 7870, 7874, 7878, 7879, 7880, 7882, 7887, 7888, 7894, 7897, 7899, 7903, 7906, 7913, 7917, 7919 and 7922. System Code #728246, Serial #: 3079, 3090, 3127, 3410, 3478, 3500, 3679, 3721, 5067, 5072, 5073, 5143, 5317, 5439, 5663, 5728, 5741, 5928, 5971, 6028, 6052, 6061, 6067, 6090, 6107, 6133, 6147, 6153, 6156, 6162, 6231, 6491, 6556, 6606, 6607, 6608, 6609, 6610, 6611, 6612, 6613, 6614, 6615, 6616, 6617, 6618, 6619, 6620, 6621, 6622, 6623, 6624, 6625, 6626, 6627, 6628, 6629, 6630, 6631, 6632, 6633, 6634, 6635, 6636, 6637, 6638, 6639, 6640, 6641, 6642, 6643, 6644, 6645, 6646, 6647, 6648, 6649, 6650, 6651, 6652, 6653, 6654, 6655, 6656, 6657, 6658, 6659, 6660, 6661, 6662, 6663, 6664, 6665, 6666, 6667, 6668, 6669, 6670, 6671, 6672, 6673, 6676, 6678, 6679, 6680, 6681, 6682, 6683, 6684, 6685, 6689, 6695, 6696, 6697, 6707, 6710, 6711, 6714, 6721, 30075, 40013, 50026, 50043, 50177, 50181, 50182, 50189, 50195, 50198, 50200 and 60009.
- Product
- Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT Big Bore…
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 258
- Distribution
- Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AR, AZ, CA, CO, CT, GA, HI, IL, IN, KS, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR,TN, TX, UT, VA, VT and WV., and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Chile, China, Denmark, Egypt, France, Germany, Honduras, India, Indonesia, Italy, Kazakhstan, Latvia, Lebanon, Libyan Arab Jamahiriya, Mexico, Netherlands, Norway, Palestine, Philippines, Poland, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom and Vietnam.
- Recall date
- October 23, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)