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 number

Z-0979-2015

Recalling firm

Philips Medical Systems (Cleveland) Inc

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.

Status

Terminated

Initiated

2014-12-08

Posted

2015-01-15

Terminated

2015-10-01

Reason

Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.

Root cause

Process control

Action

Philips sent an Urgent - Field Safety Notice letter dated December 4, 2014 to all affected customers. The US consignees will receive this notice via certified mail and Philips Key Market representatives will distribute the FSN internationally. Additionally, A Field Service Engineer will service the system to resolve the issue. For questions contact your local Philips representative or local Philips Healthcare office.

Quantity

500 units

Distribution

US Nationwide Distribution - AR, AZ, CA, CO, FL, FL, GA, IL, IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, OR, PA, PA, SC, TN, TX, VA, and WA. The affected product was also distributed to one government consignee. The affected product was also distributed to the following foreign countries: Canada, Albania, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Cayman Islands, China, Czech Republic, Denmark, Ecuador, Ethiopia, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Libyan Arab Jamahiriya, Malaysia, Mauritius, Mexico, Myanmar, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Poland, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, United Kingdom, and Vietnam.

Lot, serial or model codes

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

510(k) numbers

["K012009","K033326","K033357","K060937"]

PMA numbers

not on file

Product code

JAK

Firm FEI

1525965

Firm city

Cleveland

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy