Philips Medical Systems (Cleveland) Inc: Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems that are 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-1646-2013

Recalling firm

Philips Medical Systems (Cleveland) Inc

Product

Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems that are 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

2013-04-15

Posted

2013-07-02

Terminated

2015-01-12

Reason

Philips Healthcare received reports from the field that certain Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 systems running software versions 2.6.1 or 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images.

Root cause

Software design

Action

Philips Healthcare sent an Urgent Medical device Correction letter dated April 15, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter states that Philips Healthcare is implementing software update versions 2.6.2 or 3.5.5 to resolve the issue and a Philips Field Service Engineer will contact each site to schedule the software installation. For questions contact your local Philips representative or local Philips Healthcare office.

Quantity

2348 total units: 2182 Brilliance CT 64 units; 95 Ingenuity Core units; and 71 Ingenuity Core128 units.

Distribution

USA Nationwide Distribution - including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

Lot, serial or model codes

The following system code numbers and associated serial numbers are affected by this recall:  System Code #728231, Serial #: 4001, 4003, 4016, 4020, 9009, 9029, 9030, 9033, 9034, 9037, 9038, 9040, 9041, 9043, 9044, 9045, 9048, 9049, 9051, 9052, 9054, 9056, 9058, 9059, 9062, 9063, 9064, 9065, 9066, 9067, 9068, 9069, 9070, 9071, 9072, 9073, 9074, 9075, 9077, 9080, 9081, 9083, 9086, 9087, 9088, 9089, 9092, 9093, 9094, 9096, 9098, 9099, 9104, 9105, 9106, 9107, 9108, 9112, 9118, 9120, 9126, 9127, 9131, 9135, 9137, 9138, 9140, 9142, 9143, 9148, 9151, 9156, 9159, 9160, 9162, 9163, 9166, 9171, 9172, 9173, 9175, 9177, 9180, 9187, 9190, 9195, 9196, 9197, 9201, 9202, 9205, 9206, 9208, 9213, 9214, 9215, 9216, 9217, 9218, 9235, 9243, 9259, 9501, 9502, 9503, 9504, 9505, 9506, 9507, 9508, 9509, 9510, 9511, 9512, 9513, 9514, 9515, 9516, 9517, 9518, 9519, 9520, 9521, 9522, 9523, 9524, 9525, 9526, 9527, 9528, 9529, 9530, 9531, 9532, 9533, 9534, 9535, 9536, 9537, 9538, 9539, 9540, 9541, 9542, 9543, 9545, 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10677, 10678, 10679, 10680, 10681, 10682, 10683, 10684, 10685, 10686, 10687, 10688, 10689, 10690, 10691, 10692, 10693, 10694, 10695, 10696, 10697, 10698, 10699, 10700, 10701, 10702, 10703, 10704, 10705, 10706, 10707, 10708, 10710, 10712, 10713, 10714, 10715, 10717, 10718, 10720, 10721, 10722, 10723, 10724, 10725, 10726, 10727, 10728, 10730, 10731, 10733, 10734, 10735, 10736, 10737, 10738, 10739, 10740, 10741, 10742, 10743, 10744, 10745, 10747, 10748, 10749, 10750, 10751, 10752, 10753, 10755, 10756, 10757, 10758, 10759, 10760, 10761, 10762, 10763, 10764, 10765, 10766, 10767, 29002, 29003, 29005, 29007, 29014, 29016, 29018, 29022, 29024, 29025, 29026, 29027, 29034, 29035, 29037, 29038, 29044, 29045, 29049, 29054, 29056, 29057, 29062, 29070, 29086, 29092, 29097, 29107, 29111, 29113, 29124, 29138, 64015, 64040, 64051, 64117, 64135, 64151, 64152, 64153, 64158, 64163, 64167, 64168, 64173, 90029, 90030, 90031, 90033, 90036, 90037, 90041, 90042, 90045, 90046, 90047, 90050, 90057, 90058, 90060, 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95393, 95394, 95395, 95396, 95397, 95398, 95399, 95400, 95401, 95402, 95403, 95404, 95405, 95406, 95407, 95408, 95409, 95410, 95411, 95412, 95413, 95414, 95415, 95416, 95417, 95418, 95419, 95420, 95421, 95422, 95424, 95425, 95426, 95427, 95428, 95429, 95430, 95431, 95432, 95433, 95434, 95435, 95436, 95437, 95438, 95439, 95440, 95441, 95442, 95443, 95444, 95445, 95446, 95447, 95448, 95449, 95450, 95451, 95452, 95453, 95454, 95455, 95456, 95457, 95458, 95459, 95461, 95462, 95463, 95464, 95465, 95466, 95467, 95468, 95469, 95470, 95471, 95472, 95473, 95474, 95475, 95476, 95477, 95479, 95480, 95481, 95482, 95483, 95484, 95485, 95486, 95487, 95488, 95489, 95490, 95491, 95492, 95493, 95494, 95495, 95496, 95497, 95498, 95499, 95500, 95501, 95502, 95503, 95504, 95505, 95506, 95507, 95508, 95509, 95510, 95511, 95512, 95513, 95514, 95515, 95516, 95517, 95518, 95519, 95520, 95521, 95522, 95523, 95524, 95525, 95526, 95527, 95528, 95529, 95530, 95531, 95532, 95533, 95534, 95535, 95536, 95537, 95538, 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95690, 95691, 95692, 95693, 95694, 95695, 95696, 95697, 95698, 95699, 95700, 95702, 95703, 95704, 95705, 95706, 95707, 95708, 95709, 95710, 95711, 95712, 95713, 95714, 95715, 95716, 95718, 95719, 95720, 95721, 95722, 95723, 95724, 95725, 95726, 95727, 95729, 95730, 95731, 95732, 95733, 95734, 95735, 95736, 95737, 95738, 95739, 95740, 95741, 95742, 95743, 95744, 95745, 95746, 95747, 95748, 95749, 95750, 95751, 95752, 95753, 95754, 95755, 95756, 95757, 95758, 95759, 95760, 95761, 95764, 95765, 95767, 95768, 95769, 95770, 95772, 95773, 95774, 95775, 95776, 95777, 95778, 95779, 95780, 95781, 95782, 95783, 95784, 95785, 95786, 95787, 95788, 95789, 95790, 95791, 95792, 95793, 95794, 95795, 95796, 95797, 95798, 95799, 95800, 95801, 95802, 95803, 95804, 95805, 95806, 95807, 95808, 95809, 95810, 95811, 95812, 95814, 95815, 95816, 95817, 95818, 95819, 95820, 95821, 95822, 95823  System Code #728321, Serial #: 310001, 310002, 310003, 310004, 310005, 310006, 310007, 310010, 310011, 310012, 310013, 310014, 310015, 310016, 310017, 310018, 310019, 310020, 310021, 310022, 310023, 310024, 310025, 310026, 310027, 310028, 310029, 310030, 310031, 310032, 310033, 310034, 310035, 310036, 310037, 310038, 310040, 310041, 310043, 310044, 310045, 310046, 310047, 310048, 310049, 310050, 310051, 310052, 310053, 310054, 310055, 310056, 310057, 310058, 310059, 310060, 310061, 310062, 310063, 310065, 310066, 310067, 310068, 310069, 310071, 310072, 310073, 310074, 310075, 310076, 310077, 310078, 310079, 310080, 310082, 310083, 310084, 310085, 310086, 310087, 310088, 310089, 310090, 310091, 310092, 310093, 310094, 310095, 310096, 333001, 333007 System Code #728323, Serial #: 320002, 320003, 320004, 320005, 320006, 320007, 320008, 320009, 320010, 320011, 320013, 320014, 320015, 320017, 320018, 320019, 320020, 320022, 320023, 320024, 320025, 320026, 320027, 320028, 320029, 320031, 320032, 320034, 320035, 320036, 320037, 320038, 320039, 320040, 320041, 320043, 320044, 320045, 320046, 320047.320048, 320049, 320050, 320051, 320052, 320053, 320054, 320055, 320056, 320057, 320059, 320060, 320062, 320063, 320064, 320065, 320066, 320067, 320068, 320069, 320070, 320071, 320072, 320074, 320075, 320078, 320079

510(k) numbers

["K033326"]

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

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