device · product 1 of 1
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
- Initiated
- December 08, 2014
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 500 units
App-derived interpretation
Improper assembly
Official device-enrichment evidence · Sourced
Process control
Inspect official wording and provenance
Reason for recall
Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.
Code information
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
Distribution pattern
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.