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.

Recall details

Manufacturer

Philips Medical Systems (Cleveland) Inc

Distributor

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.

Lot

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,

Risk classification

Class II

Area (FDA)

device

Country

United States