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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Philips Medical Systems (Cleveland) Inc: The firm discovered Ring/Dot artifact due to X-ray measurement error.

Agency Publication Date: October 30, 2015
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Affected Products

Product: Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.

Model No. 728246; S/N: 3007, 3016, 3047, 3095, 3127, 3331, 3359, 3410, 3478, 3482, 3500, 3679, 3702, 4042, 5049, 5067, 5068, 5072, 5073, 5094, 5097, 5143, 5169, 5174, 5223, 5249, 5297, 5317, 5368, 5439, 5546, 5638, 5663, 5703, 5728, 5740, 5741, 5916, 5928, 5971, 6028, 6030, 6052, 6061, 6067, 6070, 6085, 6090, 6107, 6111, 6117, 6133, 6147, 6153, 6156, 6161, 6162, 6231, 6255, 6491, 6556, 657, 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, 6674, 6675, 6676, 6677, 6678, 6679, 6680, 6681, 6682, 6683, 6684, 6685, 6686, 6687, 6688, 6689, 6690, 6691, 6692, 6693, 6694, 6695, 6696, 6697, 6698, 6699, 6700, 6701, 6702, 6703, 6704, 6705, 6706, 6707, 6708, 6709, 6710, 6711, 6712, 6713, 6714, 6715, 6716, 6717, 6718, 6719, 6720, 6721, 6722, 6723, 6724, 6725, 6726, 6727, 6728, 6729, 6730, 6731, 6732, 6733, 6734, 6735, 6736, 6737, 6738, 6740, 6741, 6742, 6743, 6744, 6745, 6746, 6747, 6748, 6749, 6750, 6751, 6752, 6753, 6754, 6755, 6756, 6757, 6758, 6759, 6760, 6761, 6762, 6763, 6764, 6765, 6766, 6767, 6768, 6769, 6770, 6771, 6772, 6773, 6774, 6775, 6776, 6777, 6778, 6779, 6780, 6781, 6782, 6783, 6784, 30033, 30049, 30063, 30070, 30075, 30103, 30115, 30123, 40013, 40018, 50026, 50043, 50068, 50177, 50182, 50189, 50195, 50198, 50200, 50213, 50216, 50217, 50218, 50219, 50220, 50221, 50222, 50223, 50224, 50225, 50226, 50227, 50228, 260010, 260011, 260013, 260014, 260015, 260016, 260017, 260018, 260032, 260033, 260035, 260036, 260037, 260038, 260039, 260047, 260048, 260049, 260050, 260051, 260052, 260053, 260054, 260055, 260056, 260057, 260058, 260059, 260060, 260061, 260062, 260063, 260064, 260065, 260066, 260067, 260068, 260069, 260070, 260071, 260072, 260073, 260074, 260075, 260076, 260077, 260078, 260079, 260080, 260081, 260082, 260083, 260084, 260085, 260086, 260087, 260088, 260089 & 260090.

Product: Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.

Model No. 728231; S/N: 2, 9030, 9047, 9050, 9152, 9168, 9234, 9250, 9542, 9552, 9627, 9664, 9690, 9801, 9915, 9996, 9999, 10009, 10066, 10196, 10804, 10807, 29009, 29039, 29047, 29049, 29051, 29070, 29135, 29151, 90035, 90056, 90069, 90085, 90156, 90189, 90192, 95054, 95120, 95138, 95164, 95259, 95285, 95345, 95350, 95359, 95403, 95441, 95442, 95470, 95480, 95497, 95498, 95502, 95517, 95521, 95522, 95561, 95633, 95643, 95656, 95695, 95884, 95885, 95886, 95889, 95893, 95894, 95896, 95897, 95898, 95899, 95900, 95901, 95902, 95903, 95904, 95905, 95906, 95907, 95908, 95909, 95910, 95911, 95912, 95913, 95914, 95915, 95916, 95917, 95918, 95919, 95920, 95921, 95922, 95923, 95924, 95925, 95926, 95927, 95928, 95929, 95930, 95931, 95933, 95934, 95936, 95937, 95938, 95940, 95941, 95942, 95944 & 95946.

Product: Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.

Model No. 728321; S/N: 52000, 52001, 52002, 52003, 52004, 52006, 52009, 52011, 52012, 52015, 52016, 52017, 52020, 52022, 52025, 52027, 52029, 310116, 310150, 310152, 310153, 310154, 310155, 310156, 310158, 310161, 310162, 310163, 310164, 310166, 310171, 333013, 333026, 333027, 333028, 333032, 333035, 333036, 333037, 333038, 333039 &333042.

Product: Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.

Model No. 728323; S/N: 30153, 32001, 32002, 32003, 32004, 32005, 32006, 32007, 32009, 32011, 32012, 32014, 32017, 32019, 32020, 32022, 32023, 32024, 32025, 32027, 32028, 32029, 32030, 32031, 32035, 32038, 32039, 32040, 32041, 32046, 32048, 32052, 32053, 32058, 32059, 32060, 32065, 32066, 320124, 320128, 320135, 320136, 320137, 320139, 320140, 320141, 320142, 320143, 320145, 320148, 320149, 320150, 336030, 336031, 336032, 336033, 336034, 336035, 336036, 336037, 336038, 336039, 336040, 336042, 336043, 336045, 336047, 336048, 336049, 336050, 336051, 336052, 336053, 336055, 336056, 336057, 336058, 336063, 336065, 336069, 336074, 336701, 336702, 336703, 336704, 336705, 336706, 336707, 336708, 336709, 336710, 336711, 336712, 336713, 336714, 336715, 336716, 336717, 336718, 336719, 336720, 336721, 336722, 336723, 336724, 336725, 336726, 336727, 336728, 336729, 336730, 336731, 336732, 336733, 336734, 336735, 336736 & 336737.

Product: Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.

Model No. 728243; S/N: 7007, 7013, 7015, 7020, 7023, 7028, 7059, 7061, 7072, 7083, 7086, 7087, 7101, 7123, 7124, 7128, 7158, 7170, 7173, 7178, 7193, 7204, 7214, 7221, 7228, 7231, 7235, 7246, 7262, 7265, 7273, 7284, 7328, 7347, 7353, 7364, 7365, 7370, 7395, 7400, 7403, 7434, 7435, 7462, 7467, 7481, 7484, 7596, 7612, 7775, 7794, 7795, 7803, 7840, 7841, 7842, 7843, 7846, 7847, 7848, 7849, 7850, 7851, 7852, 7853, 7854, 7855, 7856, 7857, 7858, 7859, 7860, 7861, 7863, 7864, 7865, 7866, 7867, 7868, 7869, 7872, 7873, 7875, 7876, 7877, 7881, 7883, 7884, 7885, 7886, 7888, 7889, 7890, 7891, 7892, 7893, 7895, 7896, 7898, 7900, 7901, 7902, 7904, 7905, 7907, 7908, 7909, 7910, 7911, 7914, 7916, 7918, 7920, 7921, 7923, 7924, 7925, 7927, 7928, 7929, 7931, 7932, 7933, 7935, 7936, 7937, 7938, 7939, 7940, 7941, 7942, 7943, 7944, 7945, 7946, 7948, 7949, 7950, 7953, 7954, 7955, 7956, 7960, 7961, 7962, 7963, 7968, 7969, 7970, 7971, 7972, 7973, 7974, 7975, 7976, 7977, 7978, 7980, 7981, 7982, 7983, 7984, 7985, 7987, 7989, 7990, 7991, 7992, 7993, 7994, 7995, 7996, 7997, 7998, 7999, 8000, 8001, 8002, 8004, 8005, 8006, 8007, 75002, 75003, 75004, 75005, 75006, 75007, 75008, 75009, 75010, 75011, 75012, 75013, 75014, 75015, 75016, 75017, 75018, 75019, 75020, 75021, 75022, 75023, 75024, 75025, 75026, 75027, 75028, 75029, 75031, 75032, 75033, 75034, 75035, 75036, 75037, 75039, 75040, 75041, 75042, 75043, 75044, 75046, 75047, 75048, 75049, 75050, 75054, 75060, 75065, 75100, 75102, 75104, 75108 & 750002. Model No. 728244; S/N: 7121, 7176, 7271, 7595, 7764, 7844, 7845, 7862, 7870, 7871, 7874, 7878, 7879, 7880, 7882, 7887, 7894, 7897, 7899, 7903, 7906, 7912, 7913, 7915, 7917, 7919, 7922, 7926, 7930, 7934, 7952, 7957, 7958, 7959, 7964, 7965, 7967, 7979, 7981, 7986, 7988, 75106 & 75110.

Product: Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.

Model No. 728317; S/N: 1, 78807, 260002, 260003, 340002, 340003, 345001, 345002, 345003, 345004, 345005, 345006, 345007, 345010, 345012, 345013, 345014, 345016, 345017, 345018, 345019, 345021, 345022, 345023, 345024, 345025, 345026, 345027, 345028, 345029, 345031, 345032, 345033, 345034, 345035, 345036, 345037, 345038, 345039, 345040, 345041, 345042, 345043, 345044, 345045, 345046, 345048, 345049, 345051, 345201, 345202, 345203, 345204, 345205, 345206, 345207, 345208, 345209, 345210, 345211, 345212, 345213, 345214, 345215, 345216, 345217, 345219, 345222, 345224 & 345228.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 72282
Status: Resolved
Manufacturer: Philips Medical Systems (Cleveland) Inc
Manufactured In: United States
Units Affected: 6 products (323 units; 108 units; 36 units; 109 units; 268 units total; 67 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.