Philips Medical Systems (Cleveland) Inc Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product Usage: 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. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product Usage: 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.
Brand
Philips Medical Systems (Cleveland) Inc
Lot Codes / Batch Numbers
Brilliance CT 16 Air: Model Number 728246: Serial Numbers: 3117, 6680, 6692, 6693, 6697, 6698, 6700, 6703, 6706, 6707, 6708, 6709, 6711, 6712, 6713, 6715, 6716, 6718, 6719, 6720, 6721, 6722, 6723, 6724, 6726, 6727, 6728, 6729, 6730, 6731, 6732, 6734, 6735, 6736, 6737, 6738, 6740, 6742, 6743, 6744, 6746, 6747, 6748, 6749, 6750, 6751, 6752, 6753, 6754, 6755, 6756, 6757, 6759, 6760, 6761, 6762, 6764, 6765, 6766, 6767, 6769, 6770, 6771, 6772, 6774, 6775, 6778, 6779, 6783, 6784, 50209, 50213, 50215, 50216, 50217, 50221, 50222, 50223, 50224, 50225, 50226, 50227, 260013, 260015, 260016, 260017, 260018, 260025, 260027, 260028, 260029, 260030, 260032, 260035, 260042, 260043, 260045, 260046, 270002, 270003, 270004, 270005, 270006 Brilliance CT 64: Model Number 728231: Serial Numbers: 10773, 10793, 10795, 10798, 10803, 10805, 95061, 95857, 95861, 95865, 95880, 95881, 95882, 95883, 95885, 95892, 95895, 95900, 95908, 95909, 95910, 95912, 95915, 95916, 95918, 95920, 95921, 95922, 95924, 95925, 95926, 95928, 95930, 95933, 95936, 95944 Brilliance CT Big Bore Oncology: Model Number 728243: Serial Numbers: 7884, 7890, 7909, 7923, 7925, 7927, 7928, 7929, 7936, 7938, 7940, 7941, 7942, 7944, 7945, 7948, 7949, 7955, 7956, 7963, 7968, 7969, 7970, 7971, 7973, 7975, 7976, 7977, 7980, 7984, 7989, 7990, 7991, 7994, 7995, 7996, 7999, 8002, 8005, 8006 Brilliance CT Big Bore Radiology: 728244 Serial Numbers: 7879, 7897, 7912, 7919, 7922, 7926, 7930, 7943, 7957, 7958, 7959, 7967, 7979, 7985, 7988, 7992 Brilliance iCT: Model Number 728306: Serial Numbers: 10065, 100428, 100432, 100445, 100450, 100451, 100452, 100454, 100455, 100460, 100463, 100465, 100466, 100470, 100471, 100474, 100475, 100476, 100477, 100478, 100479, 100480, 100481, 100483, 100485, 100486, 100487, 100488, 100489, 100490, 100491, 100492, 100493, 100494, 100496, 100498, 100499, 100500, 100502, 100503, 100504, 100505, 100507, 100508, 100509, 100510, 100514, 100515, 100517, 100520 Brilliance iCT SP: Model Number 728311: Serial Numbers: 200126, 200131, 200137, 200138 Ingenuity CT: Model Number 728326: Serial Numbers: 30005, 30006, 30009, 30011, 30012, 30013, 30014, 30015, 91007, 300022, 300028, 300032, 300035, 300036, 300156, 300157, 300158, 300161, 300162, 300164, 300165, 300166, 310170 Ingenuity Core: Model Number 728321: Serial Numbers: 31001, 52001, 52002, 52003, 52004, 52006, 52007, 52009, 52010, 52011, 52013, 52015, 52016, 52017, 52018, 52020, 52021, 52024, 52026, 52030, 52031, 52032, 52033, 310032, 310090, 310113, 310114, 310115, 310116, 310121, 310129, 310131, 310134, 310135, 310137, 310138, 310139, 310140, 310144, 310145, 310147, 310148, 310149, 310151, 310152, 310153, 310154, 310155, 310158, 310160, 310161, 310162, 310163, 310164, 310165, 310170, 310171, 333005, 333009, 333011, 333012, 333013, 333014, 333015, 333016, 333017, 333020, 333024, 333026, 333031, Unknown, Unknown Ingenuity Core128: Model Number 728323: 30153, 32001, 32002, 32003, 32004, 32005, 32006, 32007, 32009, 32010, 32011, 32012, 32013, 32014, 32015, 32016, 32018, 32020, 32021, 32023, 32024, 32025, 32026, 32029, 32030, 32031, 32032, 32033, 32034, 32035, 32036, 32037, 32038, 32040, 32041, 32042, 32043, 32044, 32046, 32047, 32048, 32049, 32051, 32052, 32054, 32062, 32064, 32065, 32066, 32067, 32068, 32069, 32070, 320022, 320097, 320101, 320102, 320105, 320106, 320107, 320109, 320112, 320113, 320114, 320116, 320117, 320118, 320120, 320121, 320122, 320124, 320125, 320126, 320128, 320129, 320131, 320134, 320137, 320138, 320139, 320140, 320141, 320142, 320143, 320144, 320145, 320146, 320147, 320148, 320150, 336001, 336002, 336006, 336007, 336008, 336009, 336010, 336011, 336012, 336013, 336014, 336015, 336016, 336018, 336020, 336021, 336024, 336025, 336026, 336027, 336028, 336029, 336030, 336031, 336032, 336033, 336034, 336035, 336036, 336037, 336038, 336039, 336040, 336042, 336043, 336044, 336046, 336047, 336048, 336050, 336051, 336052, 336055, 336056, 336057, 336064, 336072 Ingenuity Flex: Model Number 728317: 260002, 260003, 340002, 345001, 345002, 345003, 345004, 345005, 345006, 345007, 345010, 345012, 345013, 345014, 345016, 345017, 345018, 345022, 345024
Products Sold
Brilliance CT 16 Air: Model Number 728246: Serial Numbers: 3117,6680,6692,6693,6697,6698,6700,6703,6706,6707,6708,6709,6711,6712,6713, 6715,6716,6718,6719,6720,6721,6722,6723,6724,6726,6727,6728,6729,6730,6731, 6732,6734,6735,6736,6737,6738,6740,6742,6743,6744,6746,6747,6748,6749,6750, 6751,6752,6753,6754,6755,6756,6757,6759,6760,6761,6762,6764,6765,6766,6767, 6769,6770,6771,6772,6774,6775,6778,6779,6783,6784,50209,50213,50215,50216, 50217,50221,50222,50223,50224,50225,50226,50227,260013,260015,260016, 260017,260018,260025,260027,260028,260029,260030,260032,260035,260042, 260043,260045,260046,270002,270003,270004,270005,270006 Brilliance CT 64: Model Number 728231: Serial Numbers: 10773,10793,10795,10798,10803,10805,95061,95857,95861,95865,95880,95881, 95882,95883,95885,95892,95895,95900,95908,95909,95910,95912,95915,95916, 95918,95920,95921,95922,95924,95925,95926,95928,95930,95933,95936,95944 Brilliance CT Big Bore Oncology: Model Number 728243: Serial Numbers: 7884,7890,7909,7923,7925,7927,7928,7929,7936,7938,7940,7941,7942,7944,7945, 7948,7949,7955,7956,7963,7968,7969,7970,7971,7973,7975,7976,7977,7980,7984, 7989,7990,7991,7994,7995,7996,7999,8002,8005,8006 Brilliance CT Big Bore Radiology: 728244 Serial Numbers: 7879,7897,7912,7919,7922,7926,7930,7943,7957,7958,7959,7967,7979,7985,7988, 7992 Brilliance iCT: Model Number 728306: Serial Numbers: 10065,100428,100432,100445,100450,100451,100452,100454,100455,100460, 100463,100465,100466,100470,100471,100474,100475,100476,100477,100478, 100479,100480,100481,100483,100485,100486,100487,100488,100489,100490, 100491,100492,100493,100494,100496,100498,100499,100500,100502,100503, 100504,100505,100507,100508,100509,100510,100514,100515,100517,100520 Brilliance iCT SP: Model Number 728311: Serial Numbers: 200126,200131,200137,200138 Ingenuity CT: Model Number 728326: Serial Numbers: 30005,30006,30009,30011,30012,30013,30014,30015,91007,300022,300028,300032,300035,300036,300156,300157,300158,300161,300162,300164,300165,300166, 310170 Ingenuity Core: Model Number 728321: Serial Numbers: 31001,52001,52002,52003,52004,52006,52007,52009,52010,52011,52013,52015, 52016,52017,52018,52020,52021,52024,52026,52030,52031,52032,52033,310032, 310090,310113,310114,310115,310116,310121,310129,310131,310134,310135, 310137,310138,310139,310140,310144,310145,310147,310148,310149,310151, 310152,310153,310154,310155,310158,310160,310161,310162,310163,310164, 310165,310170,310171,333005,333009,333011,333012,333013,333014,333015, 333016,333017,333020,333024,333026,333031,Unknown,Unknown Ingenuity Core128: Model Number 728323: 30153,32001,32002,32003,32004,32005,32006,32007,32009,32010,32011,32012, 32013,32014,32015,32016,32018,32020,32021,32023,32024,32025,32026,32029, 32030,32031,32032,32033,32034,32035,32036,32037,32038,32040,32041,32042, 32043,32044,32046,32047,32048,32049,32051,32052,32054,32062,32064,32065, 32066,32067,32068,32069,32070,320022,320097,320101,320102,320105,320106, 320107,320109,320112,320113,320114,320116,320117,320118,320120,320121, 320122,320124,320125,320126,320128,320129,320131,320134,320137,320138, 320139,320140,320141,320142,320143,320144,320145,320146,320147,320148, 320150,336001,336002,336006,336007,336008,336009,336010,336011,336012, 336013,336014,336015,336016,336018,336020,336021,336024,336025,336026, 336027,336028,336029,336030,336031,336032,336033,336034,336035,336036, 336037,336038,336039,336040,336042,336043,336044,336046,336047,336048, 336050,336051,336052,336055,336056,336057,336064,336072 Ingenuity Flex: Model Number 728317: 260002,260003,340002,345001,345002,345003,345004,345005,345006,345007, 345010,345012,345013,345014,345016,345017,345018,345022,345024
Philips Medical Systems (Cleveland) Inc is recalling Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product due to Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 11, 2026