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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP

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 Class 2 Recall
Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP
see related information
Date Posted March 13, 2013
Recall Status1 Terminated on April 17, 2014
Recall Number Z-0945-2013
Recall Event ID 64401
Premarket Notification
510(K) Numbers
K010817  K012009  K033326  K033357  K060937 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product 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.
Code Information 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
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland, Ohio 44143-2131
For Additional Information Contact Michael McAndrew
800-722-9377 Ext. 5
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
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.
Quantity in Commerce 4797 Units
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = MARCONI MEDICAL SYSTEMS, INC.
510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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