Events

Retiro De Equipo (Recall) de Device Recall Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Philips Medical Systems (Cleveland) Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    64401
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0945-2013
  • Fecha de inicio del evento
    2012-12-20
  • Fecha de publicación del evento
    2013-03-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116035
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, x-ray, tomography, computed - Product Code JAK
  • Causa
    Philips healthcare received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. philips has determined the cause was a malfunction of the vertical brake.
  • Acción
    Philips Healthcare sent a "Urgent Medical Device Correction" letter dated December 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were informed Philips received reports from the field stating that the screws holding the vertical brake together failed. A Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. If you need any further information please contact your local Philips representative or local Philips Healthcare office. For North America and Canada Contact the Customer Care Solutions Center at ( 1-800-722-9377, option 5: Enter Site ID or follow the prompts.

Device

Device Recall Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX800...
  • Modelo / Serial
    System Code #728256, Serial #:  3001,3016,3019,3020,3025,3026,3030,3057,3058,3060,3071,3073,3074,3076,3080,3090,3095,3108,3114,3119,3124,3138,3151,3155,3167,3168,3174,3178,3186,3187,3192,3193,3196,3208,3210,3212,3213,3214,3218,3226,3245,3257,3264,3267,3269,3273,3274,3275,3281,3284,3289,3291,3296,3304,3306,3309,3313,3317,3327,3331,3336,3337,3339,3340,3341,3342,3344,3345,3346,3347,3348,3349,3350,3351,3352,3354,3355,3356,3357,3358,3359,3360,3361,3362,3363,3364,3365,3366,3367,3368,3369,3370,3371,3372,3373,3374,3375,3376,3377,3378,3379,3380,3381,3382,3383,3384,3385,3386,3387,3388,3389,3390,3391,3392,3393,3394,3395,3396,3397,3398,3399,3400,3402,3403,3404,3405,3406,3408,3409,3410,3411,3412,3413,3414,3415,3416,3417,3418,3419,3420,3421,3422,3423,3424,3425,3426,3427,3428,3429,3430,3431,3432,3433,3434,3435,3436,3437,3438,3439,3440,3441,3443,3444,3445,3447,3449,3450,3451,3452,3453,3454,3455,3456,3457,3458,3459,3460,3461,3462,3463,3464,3465,3466,3467,3468,3469,3470,3471,3472,3473,3474,3475,3476,3477,3478,3479,3480,3481,3482,3483,3484,3485,3486,3487,3488,3489,3490,3491,3492,3493,3494,3495,3496,3497,3498,3499,3500,3501,3502,3503,3504,3505,3506,3507,3508,3509,3510,3511,3512,3513,3514,3515,3516,3517,3518,3519,3520,3521,3522,3523,3524,3525,3526,3527,3528,3529,3530,3531,3532,3533,3534,3535,3536,3537,3538,3539,3540,3541,3542,3543,3544,3545,3546,3547,3548,3549,3550,3551,3552,3553,3554,3555,3556,3557,3558,3559,3560,3561,3562,3563,3564,3565,3566,3567,3568,3569,3570,3571,3572,3573,3574,3575,3576,3577,3578,3579,3580,3581,3582,3583,3584,3585,3586,3587,3588,3589,3590,3591,3592,3593,3594,3595,3596,3597,3598,3599,3600,3601,3602,3603,3604,3605,3606,3607,3608,3609,3610,3611,3612,3613,3614,3615,3616,3617,3618,3619,3620,3621,3622,3623,3624,3625,3626,3627,3628,3629,3630,3631,3632,3633,3634,3635,3636,3637,3638,3639,3640,3641,3642,3643,3644,3645,3646,3647,3648,3649,3650,3651,3652,3653,3654,3655,3656,3657,3658,3659,3660,3661,3663,3664,3665,3666,3667,3668,3669,3670,3671,3672,3673,3674,3675,3676,3677,3678,3679,3680,3681,3682,3683,3684,3685,3686,3687,3688,3689,3690,3691,3692,3693,3694,3695,3696,3697,3698,3699,3700,3701,3702,3703,3704,3705,3706,3707,3708,3709,3710,3711,3712,3713,3714,3715,3716,3717,3718,3719,3720,3721,3722,6039,6040,30003,30004,30006,30007,30008,30009,30012,30013,30015,30016,30021,30026,30028,30029,30030,30031,30036,30037,30038,30039,30046,30047,30050,30053,30054,30057,30060,30062,30065,30066,30072,30073,30075,30078,30079,30082,30083,30089,30090,30094,30100,30101,30103,30105,30109,30110,30111,30117,30118,30120,30122,30124,30125,30126,30128,30129,30130,30131  System Code #728251, Serial #: 3008,3098,4006,4007,4010,4011,4012,4016,4023,4031,4039,4050,4058,4061,4062,4063,4064,4065,4066,4067,40004,40005,40006,40007,40008,40009,40010,40011,40012,40014,40015,40016,40017,40018,40021,40025,40028,40030,40032  System Code #728246, Serial #: 3012,3013,3015,3017,3023,3027,3031,3043,3070,3072,3160,3185,3189,3191,3224,3295,3448,4018,4019,4024,4025,4043,4051,5001,5005,5006,5007,5013,5014,5016,5019,5022,5023,5024,5025,5028,5029,5032,5034,5036,5038,5046,5051,5052,5053,5055,5058,5059,5061,5063,5064,5069,5070,5074,5075,5077,5083,5086,5097,5102,5105,5106,5107,5108,5110,5111,5112,5113,5115,5116,5117,5119,5122,5123,5124,5125,5127,5130,5136,5137,5138,5139,5141,5143,5150,5151,5156,5158,5161,5169,5174,5179,5183,5184,5187,5188,5190,5195,5198,5202,5207,5211,5215,5217,5218,5220,5221,5224,5226,5228,5229,5230,5234,5249,5250,5252,5254,5265,5270,5274,5278,5282,5283,5285,5286,5287,5290,5291,5295,5296,5299,5309,5313,5315,5316,5317,5318,5319,5323,5328,5329,5331,5334,5343,5364,5365,5366,5367,5370,5371,5372,5375,5376,5377,5378,5379,5380,5381,5382,5383,5384,5385,5386,5387,5388,5389,5391,5392,5393,5394,5396,5397,5398,5399,5400,5401,5402,5403,5404,5405,5406,5407,5408,5409,5410,5411,5412,5414,5415,5416,5417,5418,5419,5420,5421,5422,5423,5424,5425,5426,5427,5428,5429,5432,5433,5434,5435,5437,5438,5439,5441,5442,5443,5444,5446,5447,5448,5449,5450,5451,5453,5457,5458,5459,5460,5461,5462,5463,5464,5466,5468,5471,5473,5474,5477,5478,5479,5480,5481,5482,5484,5485,5486,5487,5488,5489,5490,5491,5492,5493,5494,5496,5497,5498,5501,5502,5503,5504,5505,5506,5507,5508,5509,5510,5511,5513,5514,5515,5516,5517,5518,5519,5520,5522,5523,5524,5525,5526,5528,5530,5531,5532,5533,5534,5535,5536,5537,5538,5539,5540,5541,5542,5543,5544,5545,5546,5547,5548,5549,5550,5551,5552,5553,5554,5555,5556,5557,5558,5559,5560,5561,5562,5563,5564,5565,5566,5567,5568,5569,5570,5571,5572,5573,5574,5575,5576,5577,5578,5579,5580,5581,5582,5583,5584,5585,5586,5587,5588,5589,5590,5591,5592,5593,5594,5595,5596,5597,5598,5599,5600,5601,5602,5603,5604,5605,5606,5607,5608,5609,5610,5611,5612,5613,5614,5615,5616,5617,5618,5619,5620,5621,5622,5623,5624,5625,5626,5627,5628,5629,5630,5631,5632,5633,5634,5635,5636,5637,5638,5639,5640,5641,5642,5643,5644,5645,5646,5647,5648,5649,5650,5651,5653,5654,5655,5656,5657,5658,5659,5660,5661,5662,5663,5664,5665, 5666,5667,5668,5669,5670,5671,5672,5673,5674,5675,5676,5677,5678,5679,5680,5681,5682,5683,5684,5685,5686,5687,5688,5689,5690,5691,5692,5693,5694,5695,5696,5697,5698,5699,5700,5701,5702,5703,5704,5705,5706,5707,5708,5709,5710,5711,5712,5713,5714,5715,5716,5717,5718,5719,5720,5721,5722,5723,5724,5727,5728,5729,5730,5731,5732,5733,5734,5735,5736,5737,5738,5739,5740,5741,5742,5743,5744,5745,5746,5747,5748,5749,5750,5751,5752,5753,5754,5755,5756,5757,5758,5759,5760,5761,5762,5763,5764,5765,5766,5767,5768,5769,5770,5771,5772,5773,5774,5775,5776,5777,5778,5779,5780,5781,5782,5783,5784,5785,5786,5787,5788,5789,5790,5791,5792,5793,5794,5795,5796,5797,5798,5799,5800,5801,5802,5803,5804,5805,5806,5807,5808,5809,5810,5811,5812,5813,5814,5815,5816,5817,5818,5819,5820,5821,5822,5823,5824,5825,5826,5827,5828,5829,5830,5831,5832,5833,5834,5835,5836,5837,5838,5839,5840,5841,5842,5843,5844,5845,5846,5847,5848,5849,5850,5851,5852,5853,5854,5855,5856,5857,5858,5859,5860,5861,5862,5863,5864,5865,5866,5867,5868,5869,5870,5871,5872,5873,5874,5875,5876,5877,5878,5879,5880,5881,5882,5883,5884,5885,5886,5887,5888,5889,5890,5891,5892,5893,5894,5895,5896,5897,5898,5899,5900,5901,5902,5903,5904,5905,5906,5908,5909,5910,5911,5912,5913,5914,5915,5916,5917,5918,5919,5920,5921,5922,5923,5924,5925,5926,5927,5928,5929,5930,5931,5932,5933,5934,5935,5936,5937,5938,5939,5940,5941,5942,5943,5944,5945,5946,5947,5948,5949,5950,5951,5952,5953,5954,5955,5956,5957,5958,5959,5960,5961,5962,5963,5964,5965,5966,5967,5968,5969,5970,5971,5972,5973,5974,5975,5976,5977,5978,5979,5980,5981,5982,5983,5984,5985,5986,5987,5988,5989,5990,5991,5992,5993,5994,5995,5996,5997,5998,5999,6000,6001,6002,6003,6004,6005,6006,6008,6009,6010,6011,6012,6013,6014,6015,6016,6017,6018,6020,6021,6022,6023,6024,6025,6026,6027,6028,6029,6030,6031,6032,6033,6034,6035,6036,6037,6038,6039,6040,6041,6042,6043,6044,6045,6046,6047,6048,6049,6050,6051,6052,6053,6054,6055,6056,6057,6058,6059,6060,6061,6062,6063,6064,6065,6066,6067,6068,6069,6070,6071,6072,6073,6074,6075,6076,6077,6078,6079,6080,6081,6082,6083,6084, 6085,6086,6087,6088,6089,6090,6091,6092,6093,6094,6095,6096,6097,6098,6099,6100,6101,6102,6103,6104,6105,6106,6107,6108,6109,6110,6111,6112,6113,6114,6115,6116,6117,6118,6119,6120,6121,6122,6123,6124,6125,6126,6127,6128,6129,6130,6131,6132,6133,6134,6135,6136,6137,6138,6139,6140,6141,6142,6143,6144,6145,6146,6147,6148,6149,6150,6151,6152,6153,6154,6155,6156,6157,6158,6159,6160,6162,6163,6165,6166,6167,6168,6169,6170,6171,6172,6173,6174,6175,6176,6177,6178,6179,6180,6181,6182,6183,6184,6185,6186,6187,6188,6189,6190,6191,6192,6193,6194,6195,6196,6197,6198,6199,6200,6201,6202,6203,6204,6205,6206,6207,6208,6209,6210,6211,6212,6213,6214,6215,6216,6217,6218,6219,6220,6221,6222,6223,6224,6225,6226,6227,6228,6229,6230,6231,6232,6233,6234,6235,6236,6237,6238,6239,6240,6241,6242,6243,6244,6245,6246,6247,6248,6249,6250,6251,6252,6253,6254,6255,6256,6257,6258,6259,6260,6261,6263,6264,6265,6266,6267,6270,6271,6272,6273,6274,6275,6276,6277,6278,6279,6280,6281,6282,6283,6284,6285,6286,6287,6288,6289,6290,6291,6292,6293,6294,6295,6296,6297,6298,6299,6300,6301,6302,6303,6304,6305,6306,6307,6308,6309,6310,6311,6312,6313,6314,6315,6316,6317,6318,6319,6320,6321,6322,6323,6324,6325,6326,6327,6328,6329,6330,6331,6332,6333,6334,6335,6336,6337,6338,6340,6341,6342,6343,6344,6345,6346,6347,6348,6349,6350,6351,6352,6353,6354,6355,6356,6357,6358,6359,6360,6361,6362,6363,6364,6365,6366,6367,6368,6369,6370,6371,6372,6373,6374,6375,6376,6377,6378,6379,6380,6382,6383,6384,6385,6386,6387,6388,6389,6392,6393,6394,6395,6397,6398,6399,6400,6401,6402,6403,6404,6405,6406,6407,6408,6409,6410,6411,6412,6413,6414,6415,6416,6417,6418,6419,6420,6421,6422,6423,6424,6425,6426,6427,6428,6429,6430,6431,6432,6433,6434,6435,6436,6437,6438,6439,6440,6441,6442,6443,6444,6445,6446,6447,6448,6449,6450,6451,6452,6453,6454,6455,6456,6457,6458,6459,6460,6461,6462,6463,6464,6465,6466,6467,6468,6469,6470,6471,6472,6473,6474,6475,6476,6477,6478,6479,6480,6481,6482,6483,6484,6485,6486,6487,6488,6489,6490,6491,6492,6493,6494,6495,6496,6497,6498,6499,6500,6501,6502,6503,6504,6505,6506,6507,6508, 6509,30019,30041,30044,30067,30069,30070,30071,30097,30119,40002,40022,40027,40035,50002,50003,50004,50009,50010,50011,50013,50014,50015,50018,50022,50023,50029,50031,50032,50033,50035,50036,50041,50042,50044,50045,50046,50049,50050,50051,50052,50055,50058,50059,50061,50062,50063,50064,50065,50066,50068,50069,50070,50073,50074,50078,50080,50081,50082,50083,50084,50086,50087,50089,50090,50091,50092,50093,50094,50095,50097,50098,50099,50101,50102,50103,50106,50109,50110,50114,50122,50124,50125,50126,50128,50129,50131,50132,50133,50134,50135,50136,50137,50138,50140,50141,50142,50153,50154,50155,50156,50157,50158,50159,50160,50161,50162,50163,50164,50165,50166,50167,50168,50169,50170,50171,50172,50173,50175,50176,50177,50178,50179,50180,50181,50182,50183,60015,60020  System Code #728240, Serial #: 5003,5043,5175,5251,5284,5373,5374,5390,5395,5413,5430,5431,5436,5440,5445,5454,5455,5456,5465,5467,5469,5470,5472,5475,5476,5483,5495,5499,5500,5512,5521,5527,5822,6006,6009,6010,6011,6013,6021,6024,6026,6027,6028,6029,6030,6031,6032,6033,6034,6035,6036,6041,6045,6046,6047,6048,6049,6054,6055,6057,6058,6059,6060,6064,6066,6067,6069,6070,6071,6072,6075,6080,6081,6082,6083,6085,6089,6090,6095,6096,6099,6100,6101,6102,6103,6104,6105,6106,6112,6113,6115,6117,6119,6121,6123,6127,6129,6130,6131,6133,6134,6136,6137,6138,6139,6141,6144,6146,6148,6150,6154,6155,6156,6157,6159,6160,60002,60005,60009,60011,60012,60014,60018,60021,60022,60025,60027,60029  System Code #728235, Serial #: 9031,9036,9039,9061,9085,9088,9094,9097,9103,9104,9114,9116,9125,9129,9130,9132,9144,9146,9147,9149,9152,9153,9156,9157,9164,9167,9168,9169,9170,9174,9178,9181,9183,9186,9188,9189,9190,9191,9200,9203,9211,9212,9220,9233,9260,9265,9272,29008,29010,29011,29012,29015,29017,29019,29020,29023,29024,29028,29030,29033,29042,29043,29046,29048,29051,29055,29059,29060,29061,29062,29065,29067,29070,29071,29072,29075,29077,29078,29080,29084,29085,29086,29087,29088,29089,29090,29091,29092,29093,29094,29095,29096,29097,29098,29099,29100,29101,29102,29103,29104,29105,29106,29107,29108,29109,29111,29112,29113,29114,29116,29117,29118,29119,29120,29121,29122,29123,29124,29125,29126,29127,29128,29129,29130,29131,29132,29134,29135,29136,29137,29138,29139,29140,29141,29142,29143,29144,29145,29146,29147,29148,29149,29150,29151,29152,29153,90034,90043,90046,90048,90051,90053,90056,90058,90059,90064,90065,90069,90071,90075,90076,90083,90095,90101,90103,90108,90110,90111,90121,90122,90125,90126,90128,90130,90134,90144,90145,90146,90148,90149,90153,90155,90164,90166,90171,90172,90173,90176,90178,90179,90181,90184,90186,90187,90189,90191,90192,90195,90196,90197,90200,90204,90206,90213,90214,90221,90223,90224,90225,90226,90227,90228,90229,90230,90231,90232,90233,90234,90235,90236,90237  System Code #728231, Serial #: 4001,4003,4016,4021,9009,9037,9038,9041,9044,9045,9048,9049,9052,9056,9059,9062,9066,9069,9074,9075,9077,9080,9087,9089,9092,9105,9108,9118,9120,9137,9142,9143,9160,9162,9166,9175,9195,9197,9201,9202,9205,9206,9208,9214,9216,9217,9501,9502,9503,9514,9522,9526,9533,9538,9540,9541,9543,9544,9547,9552,9553,9554,9556,9561,9564,9566,9568,9569,9570,9575,9577,9578,9580,9584,9585,9586,9588,9590,9592,9596,9599,9607,9612,9615,9617,9620,9625,9627,9628,9630,9640,9641,9650,9654,9659,9663,9664,9670,9672,9675,9676,9678,9684,9688,9690,9694,9695,9696,9697,9703,9706,9709,9712,9713,9714,9718,9729,9731,9735,9736,9737,9738,9740,9747,9750,9751,9758,9761,9765,9766,9767,9772,9774,9777,9780,9782,9787,9788,9792,9794,9795,9797,9805,9807,9808,9811,9812,9813,9818,9820,9822,9824,9828,9830,9833,9834,9835,9837,9838,9840,9841,9843,9846,9848,9857,9866,9870,9871,9873,9874,9877,9882,9883,9902,9909,9916,9924,9933,9939,9956,9957,9958,9959,9960,9961,9962,9963,9964,9965,9966,9967,9968,9969,9970,9971,9972,9973,9974,9975,9976,9977,9978,9979,9980,9981,9982,9983,9984,9985,9986,9987,9988,9989,9990,9991,9992,9993,9994,9995,9996,9997,9998,9999,10000,10001,10002,10003,10004,10005,10006,10007,10008,10009,10010,10011,10012,10013,10014,10015,10016,10017,10018,10019,10020,10021,10022,10023,10024,10025,10026,10027,10028,10029,10030,10031,10032,10033,10034,10035,10036,10037,10038,10039,10040,10041,10042,10043,10044,10045,10046,10047,10048,10049,10050,10051,10052,10053,10054,10056,10057,10058,10059,10060,10061,10062,10063,10064,10065,10066,10067,10068,10069,10070,10071,10072,10073,10074,10075,10076,10077,10078,10079,10080,10081,10082,10083,10084,10085,10086,10087,10088,10089,10090,10091,10092,10093,10094,10095,10096,10097,10098,10099,10100,10101,10102,10103,10104,10105,10106,10107,10108,10109,10110,10111,10112,10113,10114,10115,10116,10117,10118,10119,10120,10121,10122,10123,10124,10125,10126,10127,10128,10129,10130,10131,10132,10133,10134,10135,10136,10137,10138,10139,10140,10141,10142,10143,10144,10145,10146,10147,10148,10149,10150,10151,10152,10153,10154,10155,10156,10157,10158,10159,10160,10161,10162,10163,10164,10165,10166,10167,10168,10169,10170,10171,10172,10173,10174,10175,10176,10177,10178,10179,10180,10181,10182,10183,10184,10185,10186,10187,10188,10189,10190,10191,10192,10193,10194,10195,10196,10197,10198,10199,10200,10201,10202,10203,10204,10205,10206,10207,10208,10209,10210,10211,10212,10213,10214,10215,10216,10217,10218,10219,10220,10221,10222,10223,10224,10225,10226,10227,10228,10229,10230,10231,10232,10233,10234,10235,10236,10237,10238,10239,10241,10242,10243,10244,10245,10247,10248,10249,10250,10251,10252,10253,10254,10255,10256,10257,10258,10259,10260,10261,10262,10263,10264,10265,10266,10267,10268,10269,10270,10271,10272,10273,10274,10275,10276,10277,10278,10279,10280,10281,10282,10283,10284,10285,10286,10287,10288,10289,10290,10291,10292,10293,10294,10295,10296,10297,10298,10299,10300,10301,10302,10303,10304,10305,10306,10307,10308,10309,10310,10311,10312,10313,10314,10315,10316,10317,10318,10319,10320,10321,10322,10323,10324,10325,10326,10327,10328,10330,10331,10332,10333,10334,10335,10336,10337,10338,10339,10340,10341,10342,10343,10344,10345,10346,10347,10348,10349,10350,10351,10352,10353,10354,10355,10356,10357,10358,10359,10360,10361,10362,10363,10364,10365,10366,10367,10368,10369,10370,10371,10372,10373,10374,10375,10376,10377,10378,10379,10380,10381,10382,10383,10384,10385,10386,10387,10388,10389,10390,10391,10392,10393,10394,10395,10396,10397,10398,10399,10400,10401,10402,10403,10404,10405,10406,10407,10408,10409,10410,10411,10412,10413,10414,10415,10416,10417,10418,10419,10420,10421,10422,10423,10424,10425,10426,10427,10428,10429,10430,10431,10432,10433,10434,10435,10436,10437,10438,10439,10440,10441,10442,10443,10444,10445,10446,10447,10448,10449,10450,10451,10452,10453,10454,10455,10456,10458,10459,10460,10461,10462,10463,10464,10465,10466,10467,10468,10469,10470,10471,10472,10473,10474,10475,10476,10477,10478,10479,10480,10481,10482,10483,10484,10485,10486,10487,10488,10489,10490,10491,10492,10493,10494,10495,10496,10497,10498,10499,10500,10501,10502,10503,10504,10505,10506,10507,10508,10510,10511,10513,10514,10515,10516,10517,10518,10519,10520,10521,10522,10523,10524,10525,10526,10527,10528,10529,10530,10531,10532,10533,10534,10535,10536,10537,10538,10539,10540,10541,10542,10543,10544,10545,10546,10547,10548,10549,10550,10551,10552,10553,10554,10555,10556,10557,10558,10559,10560,10561,10562,10563,10564,10565,10566,10567,10568,10569,10570,10571,10572,10573,10574,10575,10576,10577,10578,10579,10581,10582,10583,10584,10585,10586,10587,10588,10589,10590,10591,10592,10593,10594,10595,10596,10597,10598,10599,10600,10601,10602,10603,10604,10605,10606,10607,10608,10609,10610,10611,10612,10613,10614,10615,10616,10617,10618,10619,10620,10621,10622,10623,10624,10625,10626,10627,10628,10629,10630,10631,10632,10633,10634,10635,10636,10637,10638,10639,29016,29027,29035,29037,29044,29045,29049,29057,29066,64015,64045,64051,90029,90036,90037,90041,90045,90070,90072,90077,90080,90081,90082,90085,90086,90089,90091,90097,90099,90106,90107,90117,90120,90123,90124,90132,90135,90136,90137,90141,90151,90152,90154,90156,90161,90162,90167,90168,90169,90170,90177,90182,90185,95009,95011,95013,95016,95020,95021,95022,95023,95025,95026,95030,95033,95034,95035,95036,95038,95043,95044,95045,95050,95052,95054,95055,95056,95058,95060,95062,95065,95067,95068,95069,95071,95073,95074,95075,95078,95079,95081,95084,95087,95088,95090,95092,95093,95095,95096,95097,95098,95100,95103,95104,95105,95106,95107,95108,95114,95116,95118,95120,95123,95125,95126,95130,95132,95133,95134,95136,95137,95138,95139,95140,95144,95145,95146,95150,95151,95153,95156,95158,95159,95160,95163,95164,95165,95166,95176,95178,95191,95193,95198,95199,95203,95206,95207,95208,95212,95216,95219,95221,95223,95224,95225,95226,95232,95237,95238,95239,95240,95241,95242,95244,95246,95249,95251,95252,95254,95256,95259,95261,95262,95263,95265,95266,95268,95270,95271,95273,95274,95275,95276,95277,95278,95281,95285,95287,95288,95291,95293,95295,95299,95300,95302,95303,95310,95311,95312,95313,95314,95315,95316,95317,95318,95319,95320,95321,95322,95323,95324,95325,95326,95327,95328,95329,95330,95331,95332,95333,95334,95335,95336,95337,95338,95339,95340,95341,95342,95343,95344,95346,95347,95348,95349,95350,95351,95352,95353,95354,95355,95356,95357,95358,95359,95360,95361,95362,95363,95364,95365,95366,95367,95368,95369,95370,95371,95372,95373,95374,95375,95376,95377,95378,95379,95380,95381,95382,95383,95384,95385,95386,95387,95388,95389,95390,95391,95392,95393,95394,95395,95396,95397,95398,95399,95400,95401,95402,95403,95404,95405,95406,95407,95408,95409,95410,95411,95412,95413,95414,95415,95416,95417,95418,95419,95420,95421,95422,95423,95424,95425,95426,95427,95428,95429,95430,95431,95432,95433,95434,95435,95436,95437,95438,95439,95440,95441,95442,95443,95444,95445,95446,95447,95448,95449,95450,95451,95452,95453,95454,95455,95456,95457,95458,95459,95460,95461,95462,95463,95464,95465,95466,95467,95468,95469,95470,95471,95472,95473,95474,95475,95476,95477,95478,95479,95480,95481,95482,95483,95484,95485,95486,95487,95488,95489,95490,95491,95492,95493,95494,95495,95496,95497,95498,95499,95500,95501,95502,95503,95504,95505,95506,95507,95508,95509,95510,95511,95512,95513,95514,95515,95516,95517,95518,95519,95520,95521,95522,95523,95524,95525,95526,95527,95528,95529,95530,95531,95532,95533,95534,95535,95536,95537,95538,95539,95540,95541,95542,95543,95544,95545,95546,95547,95548,95549,95550,95551,95552,95553,95554,95556,95557,95559,95560,95561,95562,95563,95564,95565,95566,95567,95569,95571,95572,95573,95574,95576,95577,95578,95579,95580,95581,95582,95583,95584,95585,95586,95587,95588,95589,95590,95591,95592,95593,95594,95595,95596,95597,95598,95599,95600,95601,95603,95604,95605,95606,95607,95608,95609,95610,95611,95612,95613,95614,95615,95616,95617,95618,95619,95620,95621,95622,95623,95625,95626,95627,95628,95629,95631,95632,95633,95634,95635,95636,95637,95638,95639,95640,95641,95642,95643,95644,95645,95646,95647,95648,95649,95650,95651,95652,95653,95654,95655,95656,95657,95659,95660,95661,95662,95663,95666,95667,95668,95669,95670,95671,95672,95673,95674,95675,95676,95678,95679,95680,95681,95682,95683,95684,95685,95686,95687,95688,95689,95690,95691,95692,95693,95694,95695,95696,95697,95698,95699,95700,95701,95702,95703,95704,95705,95706,95707,95708,95709,95710,95711,95712,95713,95714,95715,95716,95717,95718,95719,95721,95722,95723,95724,95725,95726,95727,95728,95729,95730,95731,95732,95733,96494  System Code # 728243, Serial #: 7006,7008,7014,7016,7019,7025,7026,7027,7029,7030,7031,7033,7039,7042,7043,7047,7049,7050,7054,7071,7073,7076,7078,7081,7084,7086,7087,7088,7093,7095,7098,7099,7101,7102,7103,7110,7113,7114,7115,7117,7122,7124,7125,7127,7128,7130,7132,7133,7134,7136,7138,7140,7141,7142,7144,7147,7150,7151,7152,7153,7154,7156,7157,7158,7159,7160,7161,7162,7163,7164,7165,7166,7167,7168,7169,7170,7171,7173,7174,7175,7177,7178,7179,7181,7183,7184,7185,7186,7187,7188,7189,7191,7192,7193,7194,7195,7196,7197,7198,7199,7201,7202,7203,7204,7205,7206,7207,7208,7209,7210,7211,7212,7213,7214,7215,7216,7217,7218,7219,7220,7221,7222,7223,7224,7225,7226,7227,7228,7229,7230,7231,7232,7233,7234,7235,7236,7237,7238,7239,7240,7241,7242,7243,7245,7246,7247,7248,7249,7250,7251,7253,7254,7255,7256,7257,7258,7259,7260,7261,7262,7263,7264,7265,7266,7267,7269,7270,7272,7273,7274,7275,7276,7277,7278,7279,7280,7281,7282,7283,7284,7285,7286,7287,7288,7289,7290,7291,7292,7293,7294,7295,7296,7297,7299,7300,7302,7303,7304,7305,7306,7307,7308,7309,7310,7311,7312,7313,7314,7315,7316,7319,7320,7321,7322,7323,7324,7325,7326,7327,7328,7329,7330,7331,7332,7333,7334,7335,7336,7337,7338,7339,7340,7341,7342,7343,7344,7345,7346,7347,7348,7349,7350,7351,7352,7353,7354,7355,7356,7357,7358,7359,7360,7361,7362,7363,7364,7365,7366,7367,7368,7369,7370,7371,7372,7373,7374,7376,7377,7378,7379,7381,7382,7385,7387,7388,7389,7391,7392,7393,7394,7395,7397,7398,7399,7400,7401,7403,7404,7405,7406,7409,7410,7411,7412,7413,7414,7415,7416,7417,7418,7419,7420,7421,7422,7423,7424,7425,7426,7428,7429,7431,7432,7433,7434,7435,7436,7437,7438,7440,7441,7442,7443,7444,7445,7446,7447,7448,7449,7450,7451,7454,7455,7456,7457,7459,7460,7461,7462,7463,7464,7465,7466,7467,7468,7469,7470,7471,7472,7473,7474,7475,7476,7477,7478,7479,7480,7481,7482,7483,7484,7485,7487,7488,7489,7490,7491,7492,7493,7494,7495,7496,7497,7498,7499,7500,7501,7502,7503,7504,7505,7506,7507,7508,7509,7511,7512,7513,7515,7516,7517,7518,7519,7521,7522,7523,7524,7525,7526,7527,7528,7529,7530,7531,7532,7533,7534,7535,7536,7537,7538,7539,7540,7541,7542, 7544,7545,7546,7547,7548,7549,7550,7551,7552,7553,7554,7555,7556,7557,7558,7559,7560,7561,7562,7563,7564,7565,7566,7567,7568,7569,7570,7572,7573,7574,7575,7576,7577,7578,7579,7580,7581,7582,7583,7584,7585,7586,7587,7588,7589,7590,7591,7592,7593,7595,7596,7597,7598,7599,7601,7602,7603,7604,7605,7606,7607,7608,7609,7610,7611,7612,7613,7614,7615,7616,7617,7618,7620,7622,7623,7624,7625,7626,7627,7628,7629,7630,7631,7632,7633,7634,7635,7637,7638,7639,7640,7641,7642,7643,7644,7645,7646,7647,7648,7649,7650,7652,7655,7656,7657,7658,7659,7661,7662,7663,7665,7666,7667,7671,7672,7673,7674,7675,7677,7678,7679,7680,7681,7682,7684,7685,7686,7687,7689,7690,7691,7692,7693,7695,7696,7698,7699,7700,7701,7702,7703,7704,7705,7706,7707,7709  System Code #728244, Serial #: 7052,7155,7172,7176,7180,7182,7190,7200,7244,7252,7268,7271,7301,7318,7375,7380,7383,7384,7386,7390,7396,7402,7407,7408,7427,7430,7439,7452,7453,7458,7486,7510,7514,7520,7543,7571,7600,7619,7621,7636,7651,7653,7654,7660,7664,7668,7669,7670,7676,7683,7688,7694,7697,7708,7710  System Code #728244, Serial #: 7052,7155,7172,7176,7180,7182,7190,7200,7244,7252,7268,7271,7301,7318,7375,7380,7383,7384,7386,7390,7396,7402,7407,7408,7427,7430,7439,7452,7453,7458,7486,7510,7514,7520,7543,7571,7600,7619,7621,7636,7651,7653,7654,7660,7664,7668,7669,7670,7676,7683,7688,7694,7697,7708,7710  System Code # 728306, Serial #: 100019,100020,100021,100022,100023,100024,100025,100028,100031,100032,100037,100038,100039,100040,100042,100043,100044,100045,100046,100047,100048,100049,100050,100051,100052,100053,100054,100055,100056,100057,100058,100059,100060,100061,100062,100063,100064,100065,100066,100067,100068,100069,100070,100071,100072,100073,100074,100077,100078,100079,100081,100082,100083,100084,100085,100086,100087,100088,100089,100090,100091,100092,100093,100094,100095,100096,100097,100098,100099,100100,100101,100102,100103,100104,100105,100106,100107,100108,100109,100110,100111,100112,100113,100114,100115,100116,100117,100118,100119,100120,100121,100122,100123,100124,100125,100126,100127,100128,100129,100130,100131,100132,100133,100134,100135,100136,100137,100138,100139,100140,100141,100142,100143,100144,100145,100146,100147,100148,100149,100150,100151,100152,100153,100154,100155,100157,100158,100159,100160,100161,100162,100163,100164,100165,100166,100167,100168,100169,100170,100171,100172,100173,100174,100175,100176,100177,100178,100179,100180,100181,100182,100183,100184,100185,100186,100187,100188,100189,100190,100191,100192,100193,100194,100195,100196,100197,100198,100199,100200,100201,100202,100203,100204,100205,100206,100207,100208,100209,100210,100211,100212,100213,100214,100215,100216,100217,100218,100219,100220,100221,100222,100223,100224,100225,100226,100227,100228,100229,100230,100231,100232,100233,100234,100235,100236,100238,100240,100241,100242,100243,100244,100245,100246,100247,100248,100249,100250,100251,100252,100253,100254,100255,100256,100257,100258,100259,100260,100261,100262,100263,100264,100265,100266,100267,100268,100269,100270,100271,100272,100273,100274,100275,100276,100277,100278,100279,100280,100281,100282,100283,100284,100285,100286,100287,100288,100289,100290,100291,100292,100293,100294,100295,100296,100297,100298,100299,100300,100301,100302,100303,100304,100305,100306,100307,100308,100309  System Code #728311, Serial #: 200003,200004,200005,200006,200007,200008,200009,200010,200012,200013,200014,200015,200016,200017,200018,200019,200020,200021,200022,200023,200024,200025,200026,200027,200028,200029,200030,200031,200032,200033,200034,200035,200036,200037,200038,200039,200040,200041,200042,200043,200044,200045,200046,200047,200048,200049,200050,200051,200052,200053,200054,200055,200056,200057,200058,200059,200060,200061,200062,200063,200064,200065,200066,200067,200068,200069,200070,200071,200073,200074,200075,200076,200077,200078,200079,200080,200081,200082,200083,200084,200085,200086,200087,200088,200089,200090,200091,200092,200093  System Code #728231, Serial #: 310001, 310002, 310003  System Code #728130, Serial #: 8020,8022,8039,8060,8065,8067,8079,8089,8100,8105,8121,8144,8153,8169,8189,8205,8209,8211,8214,8249,8251,8252,8253,8397,8399,20302,80001,80007,80011,80015,80020
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - 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, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.
  • Descripción del producto
    Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems. || These devices are 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. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Dirección del fabricante
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA