Events

Rappel de Device Recall Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Medical Systems (Cleveland) Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    64401
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0945-2013
  • Date de mise en oeuvre de l'événement
    2012-12-20
  • Date de publication de l'événement
    2013-03-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116035
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, x-ray, tomography, computed - Product Code JAK
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA