Ingenuity

Serial Numbers 11004-11014 are subject to recall/software correction.

Radiology Devices

2

No

Worldwide distribution: USA (nationwide) including states of: OH and NY; and countries of: China, Finland, Germany, South Korea, Spain, and Switzerland.

Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380. || The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). The system does not expose the patient to any ionizing radiation. The MRI Subsystem produces cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structures of the whole body. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient 's body (specific pharmaceuticals are used for whole body, brain, and other organ imaging). The PET and MRI portion of the system can be used either as an integrated system or as a stand-alone MRI or PET system. The MRI subsystem provides data suitable for use in attenuation correction of the PET acquired data.

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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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

Radiology Devices

2

No

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.

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.

Model # 882456; Serial Number: 2003 -2013 and 2015 - 2019.

Radiology Devices

2

No

Worldwide Distribution - US (nationwide) including the states of NY, OH and Pa, and the countries of Australia, Austria, Egypt, France, Germany, India and Netherlands.

Ingenuity TF PET/CT || Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other Oran imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders The detection, localization, and staging of tumors and diagnosing cancer patients. Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of regional cerebral activity from PET images. Cardiac imaging software provides functionality for quantification of cardiology images and data sets including but not limited to myocardial perfusion for the display of wall motion and quantification ventricular or left-function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated.

Brilliance CT 6: M/N: 728256; S/N: 3001, 3002, 3005, 3007, 3014, 3016, 3019-3021, 3025, 3026, 3028, 3032-3036, 3045, 3046, 3049, 3051, 3052, 3057, 3058, 3060, 3062, 3064-3066, 3068, 3071, 3073, 3074, 3076-3081, 3083, 3084, 3090, 3093-3095, 3097, 3101, 3102, 3104, 3106-3108, 3112-3115, 3118-3121, 3124, 3126, 3128, 3129, 3131, 3132, 3134, 3136, 3137, 3139-3141, 3143-3145, 3147, 3148, 3151-3158, 3162, 3165-3169, 3171, 3173-3177, 3180, 3181, 3184-3190, 3192, 3193, 3196, 3200, 3201, 3203, 3204, 3207, 3208, 3210-3218, 3220, 3221, 3225, 3226, 3228, 3229, 3232, 3235, 3237, 3240, 3241, 3243-3245, 3248, 3249, 3253-3257, 3260-3264, 3266-3272, 3275-3282, 3284, 3285, 3287, 3290, 3292, 3296, 3299, 3301, 3303-3305, 3307-3311, 3313, 3315, 3317-3323, 3325-3328, 3332-3334, 3336, 3338, 3339, 3341, 3343-3345, 3347-3349, 3351, 3352, 3354, 3357-3364, 3366-3368, 3370-3374, 3377-3384, 3386, 3388-3391, 3394, 3396-3400, 3402-3404, 3408, 3409, 3412, 3413, 3415-3418, 3423-3426, 3428-3432, 3434-3437, 3439, 3443, 3444, 3447, 3449, 3451-3453, 3455, 3457, 3459, 3460, 3461, 3463, 3465, 3467-3475, 3477-3483, 3485, 3486, 3488, 3489, 3491-3506, 3508-3511, 3513, 3515, 3517-3519, 3522-3524, 3526, 3527, 3532-3535, 3537-3549, 3551-3553, 3556-3559, 3562, 3564, 3566, 3568, 3570, 3571, 3573-3575, 3577, 3578, 3580, 3582-3588, 3590-3595, 3597-3608, 3611-3616, 3618-3622, 3625-3632, 3634-3637, 3639-3646, 3648, 3649, 3651-3661, 3663-3665, 3667-3670, 3672, 3674-3677, 3679-3693, 3695-3698, 3703-3712, 3714, 3715, 3717-3720, 3722, 6039, 6040, 30003, 30005, 30007-30009, 30011-30018, 30021, 30022, 30024, 30026-30031, 30033-30040, 30042, 30043, 30045-30048, 30050, 30052-30054, 30056-30062, 30064-30066, 30068, 30069, 30072, 30073, 30075, 30077-30080, 30082-30090, 30092, 30094, 30100, 30101, 30104-30108, 30111, 30113, 30117-30119, 30121-30131 & 300043.  Brilliance CT 10: M/N: 728251; S/N: 3008, 3098, 4001, 4003, 4005, 4006, 4009-4012, 4014, 4016, 4020, 4021, 4023, 4026, 4027, 4029-4031, 4035, 4040, 4041, 4044, 4047-4050, 4052-4054, 4058, 4059, 4061, 4063-4067, 30099, 40006-40012, 40014-40018, 40021, 40023, 40024, 40028, 40030 & 40032-40035.  Brilliance CT 16: M/N: 728246; S/N: 3011, 3013, 3018, 3027, 3031, 3038, 3041, 3043, 3070, 3072, 3082, 3085, 3117, 3127, 3149, 3160, 3205, 3216, 3227, 3293-3295, 3302, 3306, 3324, 3336, 3376, 3393, 3466, 3490, 3514, 3521, 3563, 3565, 3624, 3647, 3673, 3721, 4004, 4017, 4018, 4019, 4024, 4025, 4036, 4043, 4055, 5001, 5004-5008, 5010-5021, 5023-5026, 5028-5032, 5034-5038, 5040-5042, 5044-5046, 5049-5055, 5058-5062, 5064, 5066-5070, 5072-5076, 5078, 5081-5086, 5088-5095, 5097-5099, 5101-5105, 5107, 5108, 5110-5118, 5120-5128, 5130-5141, 5143, 5145-5152, 5155, 5156, 5158, 5160-5164, 5166-5170, 5173-5181, 5183-5202, 5204, 5207-5209, 5211-5219, 5221-5226, 5228-5240, 5242, 5243, 5248, 5249, 5252-5254, 5258, 5264-5267, 5269-5275, 5278, 5279, 5281-5283, 5285-5297, 5301-5309, 5311-5313, 5315-5320, 5322, 5323, 5325-5332, 5334, 5336, 5338-5344, 5346-5351, 5353, 5355, 5357, 5359-5362, 5365-5369, 5371, 5372, 5375-5380, 5382, 5384, 5386-5389, 5394, 5396-5400, 5402-5410, 5414-5429, 5432-5435, 5437-5443, 5451, 5452, 5456, 5460, 5468, 5469, 5485, 5489, 5515, 5522, 5531, 5535, 5537, 5543, 5552, 5555, 5557, 5567, 5581-5584, 5586-5588, 5600, 5607, 5621, 5624, 5630, 5642, 5644, 5645, 5651, 5654, 5658, 5663, 5664, 5667, 5675, 5679, 5684, 5685, 5697, 5707, 5709, 5716, 5724, 5725, 5735, 5738, 5743-5745, 5748-5750, 5752, 5754, 5756, 5772, 5774, 5776, 5777, 5780, 5782, 5790, 5793, 5794, 5796, 5801, 5802, 5806, 5807, 5812-5815, 5823-5827, 5830-5834, 5840-5849, 5851, 5852, 5854, 5855, 5857, 5858, 5860, 5861, 5866, 5871-5873, 5880, 5881, 5882, 5884-5886, 5892, 5899, 5901, 5904, 5915, 5921-5923, 5939-5942, 5947, 5948, 5961-5963, 5966-5968, 5976, 5980, 6011, 6012, 6014, 6015, 6028, 6033, 6034, 6036-6038, 6045, 6050, 6068-6071, 6082, 6090, 6095, 6104, 6105, 6108, 6112, 6115, 6126, 6132, 6133, 6161-6165, 6173, 6180, 6221, 6240, 6241-6243, 6245-6257, 6259-6262, 6264-6273, 6275-6277, 6279-6283, 6285, 6287-6304, 6306-6317, 6319-6325, 6327-6364, 6366-6370, 6373-6380, 6382-6387, 6389, 6392-6395, 6397-6416, 6418-6421, 6423-6444, 6447-6458, 6460-6493, 6497-6500, 6502-6532, 6534-6563, 6565-6577, 6580-6590, 6592-6616, 6618-6636, 6638-6640, 6643-6645, 6647, 6648, 6650-6655, 6657, 6658, 6660-6671, 6673, 6675-6718, 6720-6726, 6729, 6733, 6738, 6740-6743, 6745, 6751, 6753-6755, 6757- 6760, 6762-6768, 30019, 30041, 30061, 30069, 30081, 30091, 30093, 30097, 30109, 32287, 40002, 40003, 40020, 40022, 40027, 50002, 50003, 50005, 50007-50013, 50015, 50016, 50018, 50021-50023, 50025-50036, 50038, 50040-50042, 50044-50059, 50061-50070, 50073-50088, 50091-50099, 50101-50107, 50109-50113, 50115, 50116, 50118-50122, 50124-50129, 50131, 50133-50138, 50141-50166, 50168, 50170, 50172, 50175-50182, 50184-50195, 50197-50200, 50202, 50204, 50206-50208, 50210 & 270001.  Brilliance CT 16 Power: M/N: 728240; S/N: 3004, 3046, 3100, 3109, 3236, 5003, 5043, 5047, 5071, 5345, 5356, 5374, 5390, 5395, 5413, 5430, 5455, 5467, 6007, 6009-6011, 6013, 6024, 6026-6028, 6031-6038, 6041-6043, 6045-6049, 6051-6060, 6062-6067, 6069-6072, 6075, 6077-6090, 6093, 6095, 6096, 6099-6113, 6115-6117, 6119, 6121-6126, 6129-6137, 6139, 6141-6151, 6153-6156, 6159, 6161-6163, 50039, 50073, 60001-60006, 60008-60014, 60017, 60022, 60024, 60025 & 60027-60029.  Brilliance CT 40: M/N: 728235; S/N: 4012, 9031, 9032, 9034, 9036, 9039, 9046, 9047, 9050, 9053, 9055, 9057, 9060, 9061, 9076, 9085, 9088, 9094, 9095, 9097, 9103, 9109, 9111, 9113-9116, 9119, 9122, 9124, 9125, 9128-9134, 9136, 9141, 9144-9147, 9149, 9150, 9153, 9154, 9157, 9158, 9161, 9164, 9165, 9167-9170, 9172, 9174, 9176, 9178-9183 9185, 9186, 9188, 9189, 9191-9194, 9198-9200, 9203,9204, 9207,9209-9212, 9219, 9222, 9225-9233, 9237-9241, 9244, 9245, 9247-9251, 9253, 9254, 9256-9258, 9260-9273, 9275, 9276, 9278-9282, 9284-9286, 29001, 29004, 29006-29008, 29010-29013, 29015, 29019-29024, 29028-29031, 29033, 29036, 29038-29041, 29043, 29046-29048, 29050, 29051, 29055, 29058-29061, 29063-29067, 29069, 29071-29073, 29075, 29077, 29078, 29080, 29082-29087, 29089-29091, 29093-29096, 29098-29106, 29108, 29109, 29113, 29114, 29116-29123, 29125, 29127-29132, 29134-29137, 29139,29140-29145, 29147-29150, 29152, 29153, 90034, 90035, 90040, 90043, 90044, 90049, 90051-90054, 90056, 90059, 90061, 90064, 90065, 90067, 90069, 90071, 90075, 90076, 90083, 90084, 90087, 90090, 90093, 90095, 90101, 90103, 90108-90110, 90121, 90122, 90125, 90126, 90130, 90138, 90142, 90144, 90146, 90148, 90149, 90155, 90157-90159, 90164-90166, 90169, 90171-90174, 90178, 90179, 90181, 90183, 90184, 90186, 90189, 90190, 90192-90194, 90196-90198, 90200, 90202-90204, 90206-90215, 90219, 90220, 90222, 90224, 90226, 90228, 90229, 90231-90237 & 92034.  Brilliance CT 64: M/N: 728231; S/N: 4001, 4003, 4016, 4020, 5006, 9029, 9030, 9033-9035, 9037, 9038, 9040, 9041, 9043-9045, 9048, 9049, 9051, 9052, 9054, 9056, 9058, 9059, 9062, 9064-9075, 9077, 9080, 9083, 9086, 9087, 9089, 9092-9094, 9098, 9099, 9104-9108, 9112, 9117, 9118, 9120, 9121, 9126, 9127, 9135, 9137, 9138, 9140-9143, 9148, 9151, 9152, 9155, 9156, 9159, 9160, 9162, 9163, 9166, 9171, 9173, 9175, 9177, 9187, 9190, 9195-9197, 9201, 9202, 9205, 9206, 9208, 9213-9218, 9235, 9236, 9243, 9255, 9259, 9501-9505, 9507-9512, 9514-9531, 9533-9536, 9538-9543, 9545-9552, 9554-9566, 9568, 9569, 9570, 9572-9585, 9587-9596, 9598-9608, 9610, 9612-9620, 9622-9655, 9657-9659, 9662-9668, 9670-9674, 9676-9680, 9683-9695, 9697-9703, 9705-9714, 9716, 9718-9720, 9722-9726, 9728-9732, 9734-9742, 9745-9761, 9763, 9765-9769, 9772-9782, 9784-9795, 9797, 9800, 9801, 9803-9813, 9815-9822, 9824, 9826, 9829, 9830, 9832-9835, 9837-9847, 9849-9853, 9858-9871, 9873-9879, 9881-9885, 9888-9896, 9898, 9899, 9901-9906, 9909-9911, 9913-9927, 9929-9934, 9936-9938, 9940-9942, 9944-9948, 9950-9956, 9958-9961, 9963-9971, 9974-10009, 10011-10028, 10031-10037, 10039-10042, 10044-10054, 10056-10073, 10075, 10077-10081, 10083-10090, 10092, 10094-10108, 10110-10132, 10134-10137, 10139-10146, 10148-10158, 10160-10162, 10164-10168, 10170-10174, 10176-10198, 10200-10235, 10237-10239, 10241-10245, 10247, 10248, 10250-10283, 10286-10288, 10291-10305, 10307-10319, 10321-10327, 10330-10339, 10341-10353, 10355, 10357-10381, 10383-10386, 10388-10402, 10404-10422, 10424-10432, 10435-10492, 10494-10500, 10502-10523, 10525-10528, 10530-10535, 10537-10543, 10545-10619, 10621-10671, 10673, 10675-10681, 10683-10689, 10691-10708, 10710, 10712-10715, 10717, 10718, 10720-10745, 10747-10762, 10765, 10767-10786, 10789, 10790, 10792, 10793, 10795-10804, 29002, 29003, 29005, 29014, 29016-29018, 29025, 29026, 29032, 29034, 29035, 29037, 29044, 29045, 29049, 29053, 29054, 29056, 29057, 29062, 29066, 29068, 29070, 29092 ,29101, 29107, 29113, 29115, 29124, 29138, 29151, 32129, 64015, 64016-64020, 64022-64039, 64041-64080, 64082-64094, 64096-64104, 64106-64112, 64115-64118, 64121-64131, 64133-64140, 64142, 64143-64154, 64157, 64158, 64160, 64162-64169, 64171-64175, 65006, 90029-90031, 90036, 90037, 90041, 90042, 90046-90048, 90057, 90058, 90060, 90062, 90063, 90066, 90070, 90072, 90074, 90077-90082, 90084-90089, 90091, 90092, 90094, 90096-90100, 90105-90107, 90117-90120, 90123, 90124, 90129, 90131, 90132, 90135-90137, 90139-90141, 90143, 90147, 90150-90154, 90156, 90160, 90161, 90163, 90167-90170, 90175-90177, 90180, 90182, 90187, 90195, 90199, 90205-90208, 90213, 90218, 90221-90223, 91003, 95003, 95008, 95009, 95011-95024, 95029-95052, 95054-95069, 95071-95076, 95078-95085, 95088-95095, 95097-95104, 95106-95114, 95116-95119, 95121-95123, 95125-95129, 95132-95143, 95147, 95149, 95151, 95153, 95154, 95157, 95161, 95162, 95165-95170, 95177, 95178, 95181-95186, 95189-95191, 95194, 95195, 95197, 95199, 95201-95204, 95207-95210, 95214, 95216-95219, 95221-95223, 95227, 95228, 95231-95234, 95236-95239, 95242, 95243, 95245-95247, 95249-95254, 95257-95259, 95261, 95262, 95264-95266, 95268-95271, 95273-95287, 95289-95294, 95296-95298, 95300, 95301, 95303-95305, 95308-95310, 95312-95335, 95338, 95342, 95344-95346, 95348-95351, 95353-95366, 95369, 95370, 95374-95376, 95378-95400, 95402-95404, 95406, 95408-95411, 95413-95436, 95438-95440, 95442-95458, 95460-95492, 95494-95529, 95531-95584, 95586, 95588-95592, 95595-95641, 95643-95662, 95664-95700, 95702-95727, 95729-95761, 95764-95770, 95772-95812, 95814-95832, 95835-95845, 95848-95858, 95860-95862, 95864-95876, 95878, 95879, 95884, 95920, 96494, 100062, 110058, 110391 & 999999.   Brilliance CT Big Bore Oncology: M/N: 728243; S/N: 7006-7009, 7013-7051, 7053-7062, 7064-7120, 7122-7142, 7144-7166, 7168, 7169, 7171, 7173-7175, 7177-7179, 7181, 7183-7186, 7188, 7189, 7191, 7192, 7194-7199, 7201-7214, 7216-7243, 7245-7247, 7249, 7250, 7253-7263, 7265-7267, 7269, 7270, 7272-7289, 7291-7295, 7297-7300, 7302, 7304, 7306-7316, 7319, 7320, 7322-7374, 7376-7379, 7381,7382, 7387-7389, 7392, 7393, 7395, 7397-7401, 7403-7406, 7409,7410,7411-7422, 7424-7426, 7428, 7429, 7431-7433, 7435-7438, 7440-7451, 7454-7457, 7459, 7461-7471, 7473-7475, 7477-7485, 7487-7509, 7511-7513, 7515-7524, 7526-7528, 7530-7532, 7534, 7535, 7537, 7539-7542, 7545, 7547-7556 ,7558-7561, 7563-7569, 7573, 7574,7577-7582, 7584, 7585, 7588-7593, 7596-7599, 7601-7603, 7605, 7606, 7608, 7609, 7611-7613, 7615-7618, 7620, 7622-7624, 7626-7630, 7634, 7635, 7637-7650, 7652, 7655-7659, 7661, 7662, 7665-7667, 7671, 7672, 7674, 7675, 7677-7681, 7684, 7685, 7687, 7689-7691, 7693, 7695, 7696, 7698-7707, 7709, 7715, 7716, 7718, 7720, 7724-7727, 7729-7731, 7735-7737, 7739-7741, 7743-7745, 7749-7755, 7757, 7759, 7761-7763, 7765, 7769, 7770, 7774-7777, 7779, 7782-7788, 7791, 7793-7797, 7799-7803, 7806-7808, 7810-7812, 7814, 7815, 7817, 7818, 7820, 7822-7824, 7827-7829, 7831-7838, 7840-7842, 7846-7852, 7855-7858, 7860, 7861, 7864-7868, 7872, 7873, 7875-7877, 7881, 7884, 7886, 7891-7893, 7895, 7896, 7898, 7900-7902, 7904, 7905, 7907-7911, 7914, 7916, 7918, 7920, 7921, 7923-7925, 7927-7929, 7931-7933, 7935-7942, 7944-7946, 7948-7950, 7955, 7956, 7963, 7968, 7970, 7972, 7973, 7976, 7984, 7987, 7990, 7991 & 7993.  Brilliance CT Big Bore Radiology: M/N: 728244; S/N: 7052, 7063, 7121, 7155, 7172, 7176, 7180, 7182, 7190, 7200, 7244, 7252, 7268, 7271, 7301, 7318, 7375, 7380, 7383, 7384, 7386, 7390, 7396, 7402, 7407, 7408, 7427, 7430, 7439, 7452, 7453, 7458, 7486, 7510, 7514, 7525, 7529, 7533, 7538, 7543, 7546, 7570, 7572, 7575, 7583, 7586, 7587, 7594, 7595, 7604, 7610, 7614, 7619, 7621, 7625, 7631, 7632, 7633, 7636, 7651, 7653, 7654, 7660, 7668-7670, 7676, 7683, 7686, 7688, 7692, 7694, 7697, 7708, 7710-7714, 7717, 7719, 7721-7723, 7732-7734, 7738, 7742, 7746, 7747, 7756, 7760, 7764, 7766, 7767, 7771-7773, 7778, 7780, 7781, 7789, 7790, 7798, 7804, 7809, 7813, 7819, 7825, 7826, 7830, 7839, 7844, 7845, 7853, 7859, 7862, 7869, 7870, 7874, 7878, 7879, 7880, 7882, 7887, 7888, 7894, 7897, 7899, 7903, 7906, 7912, 7913, 7915, 7917, 7919, 7922, 7926, 7930, 7934, 7943, 7952,7958, 7959, 7964, 7967, 7986, 7988 & 7992.  Brilliance iCT: M/N: 728306; S/N: 85000, 100016, 100019-100025, 100028, 100031, 100032, 100037-100040, 100042-100074, 100077-100079, 100081-100084, 100086-100106, 100108-100135, 100137-100142, 100144-100155, 100157-100182, 100184-100236, 100238, 100240, 100242-100254, 100256-100268, 100270-100278, 100280-100283, 100285-100297, 100299-100325, 100327, 100329-100332, 100334, 100336, 100338-100343, 100345-100350, 100352-100358, 100360-100365, 100368-100380, 100382-100389, 100391, 100393-100402, 100404-100412, 100414-100418, 100423-100426, 100429, 100430, 100433-100435, 100438-100442, 100449-100458, 100460-100462, 100464-100470, 100473, 100476, 100477, 100480-100482, 100484-100486, 100488, 100490, 100493, 100494, 100497-100499, 100503, 100505-100508, 100511, 200005, 200083, 200098 & 987654.  Brilliance iCT SP: M/N: 728311; S/N: 100039, 100062, 200003, 200006-200016, 200018-200027, 200029-200058, 200060-200065, 200067, 200068-200071, 200073-200079, 200084-200097, 200099-200117, 200119, 200120, 200123-200131, 200133-200137.  Ingenuity CT: M/N: 728326; S/N: 6372, 6395, 6569, 10607, 300005, 300011, 300012, 300014, 300016-300022, 300024, 300025, 300027-300042, 300044-300066, 300068, 300069, 300071-300075, 300077-300082, 300084-300114, 300116-300133, 300135-300140, 300142-300145, 300147-300151, 300156-300163, 300164 & 310058.  Ingenuity Core: M/N: 728321; S/N: 6563, 7700, 10614, 10621, 10633, 50171, 50204, 95732, 100507, 310001, 310004, 310006, 310008, 310009, 310010, 310012-310015, 310017, 310018, 310020-310022, 310024-310026, 310028-310035, 310037-310057, 310059-310143, 310146-310148, 310156, 310157, 310159, 333001-333003, 333005-333012, 333016 & 3100016.  Ingenuity Core128: M/N: 728323; S/N: 100315, 320002-320011, 320013-320015, 320017-320112, 320115, 320119, 320123, 320126, 320131-320133, 320135, 320136, 320140, 336001-336003, 336006-336008 & 336014.  MX8000 Dual v. EXP: M/N: 728130; S/N: 2110, 8010, 8016, 8018, 8034, 8035, 8039-8041, 8043, 8048, 8053, 8055, 8056, 8058, 8061, 8065, 8067, 8068, 8070, 8073-8077, 8079, 8081, 8082, 8084-8086, 8092, 8095, 8097, 8098, 8104, 8105-8108, 8111, 8112, 8114-8120, 8123-8125,8127-8131, 8134-8138, 8140, 8142-8147, 8149-8151, 8153-8156, 8159, 8160, 8163-8165, 8167-8169, 8171-8175, 8177, 8178, 8181, 8184-8186, 8188, 8190-8192, 8194-8196, 8198, 8199, 8201-8208, 8211-8213, 8215-8218, 8220, 8221, 8223, 8225-8227, 8232-8240, 8242, 8243, 8245, 8247-8250, 8253, 8256-8258, 8260-8289, 8292-8296, 8298-8306, 8308, 8310-8315, 8317, 8318, 8320-8324, 8326, 8328-8335, 8337-8342, 8344-8347, 8349, 8351-8355, 8357-8359, 8361-8373, 8375-8396, 8398, 8400-8407, 8409-8413, 8442, 9528, 80002-80005, 80007, 80009-80019, 80021 & 80022.  Ingenuity Flex: M/N728317; S/N: 260002, 260003, 340002, 340003, 345002, 345003 & 345004.

Radiology Devices

2

No

Worldwide Distribution: US nationwide including PR and DC, Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bhutan, Bolivia, Bosnia, Brazil, Brunei Darussalam, Bulgaria, Canada, Cambodia, Cape Verde, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dubai, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Greece, Greenland, Guadeloupe, Herzegovina, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, LAO People's Dem, Rep., Latvia, Lebanon, Libya, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Mozambique, Myanmar, Nahar, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam & Yemen.

Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners)

728321

Radiology Devices

2

No

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Mayanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Republic of Korea, Reunion, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Tanzania, Tunisia, Turkey, United Arab Emirates, Uzbekstan and Vietnam.

Philips Healthcare Ingenuity Core Computed Tomography X-ray system