Recall of Device Recall Various Brilliance and Ingenuity systems, see below

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

Radiology Devices

2

No

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.

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.