FDAFDA · Food and drugs·Recall number Z-1338-2013

Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT 6-Slice Water, System Code: 728255; MX8000 IDT 16, System Code: 728120 & MX8000 IDT 10, System Code: 728125 Computed Tomography X-ray systems. Distributed by Philips Medical Systems (Cleveland), Inc., 595 Miner Road, Cleveland, OH 44143 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

Published May 29, 2013 · Recall initiated: March 12, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Philips Healthcare received a report from the field stating when they viewed the CTDIVol information from the PACS system, the calculations were too high. Instead of storing the CTDIVol value for each slice in the DICOM tag, the system took the sum of all CTDIVol values from all the images in the dataset and stored this value in the DICOM tag, resulting in incorrect information.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: Philips Medical Systems (Cleveland) Inc
Distributor: Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, 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, TN, TX, VA, VT, WA, WI, WV and WY; countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Denmark, France, Germany, Gibraltar, India, Iraq, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Philippines, Poland, Portugal, Singapore, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom and Venezuela.
Lot: System Code #728255, Serial #: 9702, 9703, 9704, 9705, 9706, 9707, 9709, 9710, 9713, 9714, 9717, 9718, 9719, 9721, 9722, 9723, 9724, 9725, 9727, 9730, 9731, 9732, 9733, 9734, 9735, 9738, 9739, 9740, 9741, 9742, 9743, 9746, 9747, 9749, 9752, 9753, 9756, 9758, 9759, 9760, 9761, 9762, 9765, 9766, 9768, 9769, 9770, 9772, 9774, 9778, 9780, 9781, 9783, 9784, 9786, 9787, 9790, 9791, 9792, 9793, 9796, 9797, 9801, 9805, 9807, 9808 & 9810. System Code #728250, Serial #: 2556, 2557, 2560, 2562, 2563, 2565, 2567, 2568, 2569, 2570, 2571, 2574, 2576, 2577, 2579, 2580, 2581, 2584, 2585, 2587, 2588, 2590, 2591, 2592, 2593, 2594, 2595, 2597, 9738 & 9741. System Code #728245, Serial #: 2562, 2564, 2567, 2573, 2576, 2582, 2584, 2585, 2586, 2587, 2589, 2590, 2594, 2596, 2597, 3014, 3091, 3105, 3151, 3217, 3235, 3287, 3303, 3312, 3339, 3340, 3341, 3342, 3343, 3344, 3346, 3348, 3351, 3353, 3355, 3356, 3357, 3358, 3359, 3360, 3363, 3364, 3366, 3369, 3371, 3373, 3374, 3377, 3378, 3379, 3380, 3381, 3382, 3383, 3385, 3388, 3392, 3393, 3394, 3397, 3400, 3404, 3406, 3407, 3408, 3410, 3413, 3414, 3415, 3416, 3419, 3423, 3425, 3427, 3429, 3431, 3432, 3433, 3435, 3436, 3437, 3438, 3439, 3440, 3441, 3443, 3445, 3446, 3448, 3449, 3451, 3452, 3453, 3454, 3455, 3458, 3459, 3461, 3462, 3464, 3468, 3469, 3470, 3471, 3473, 3474, 3475, 3477, 3478, 3479, 3481, 3482, 3483, 3484, 3485, 3486, 3488, 3489, 3491, 3492, 3493, 3495, 3496, 3497, 3498, 3499, 3500, 3501, 3502, 3503, 3504, 3505, 3508, 3509, 3510, 3511, 3512, 3513, 3514, 3515, 3517, 9716, 9718, 9719, 9724, 9732, 9741, 9743, 9746, 9749, 9778, 9780, 9787, 9790, 9797, 9801, 9808 & 9810. System Code #728120, Serial #: 2502, 2510, 2513, 2516, 2517, 2518, 2525, 2528, 2531, 2533, 2535, 2539, 2546, 3006, 3008, 3013, 3014, 3021, 3025, 3026, 3027, 3028, 3029, 3030, 3035, 3037, 3039, 3040, 3043, 3044, 3047, 3049, 3050, 3051, 3053, 3054, 3056, 3059, 3061, 3062, 3063, 3064, 3068, 3069, 3070, 3072, 3073, 3075, 3076, 3077, 3078, 3079, 3081, 3082, 3084, 3085, 3087, 3088, 3089, 3091, 3093, 3094, 3095, 3097, 3099, 3100, 3103, 3104, 3105, 3106, 3107, 3108, 3110, 3111, 3112, 3113, 3114, 3116, 3117, 3118, 3119, 3120, 3121, 3122, 3124, 3125, 3126, 3127, 3129, 3130, 3131, 3132, 3135, 3136, 3137, 3138, 3141, 3143, 3144, 3146, 3148, 3149, 3150, 3151, 3152, 3153, 3154, 3155, 3156, 3157, 3159, 3160, 3161, 3162, 3163, 3164, 3165, 3167, 3168, 3169, 3171, 3172, 3174, 3176, 3177, 3178, 3179, 3180, 3182, 3183, 3185, 3187, 3188, 3189, 3190, 3192, 3194, 3195, 3196, 3198, 3199, 3202, 3203, 3204, 3205, 3206, 3207, 3208, 3209, 3211, 3212, 3213, 3214, 3216, 3217, 3218, 3219, 3220, 3221, 3222, 3223, 3224, 3225, 3229, 3230, 3232, 3233, 3234, 3235, 3236, 3237, 3238, 3239, 3240, 3245, 3246, 3247, 3248, 3250, 3251, 3252, 3253, 3254, 3255, 3258, 3261, 3262, 3264, 3265, 3266, 3268, 3269, 3270, 3271, 3273, 3274, 3277, 3279, 3280, 3281, 3283, 3284, 3285, 3287, 3289, 3290, 3293, 3294, 3295, 3296, 3297, 3298, 3299, 3300, 3302, 3303, 3304, 3305, 3307, 3308, 3310, 3311, 3312, 3315, 3316, 3318, 3319, 3320, 3321, 3322, 3324, 3328, 3329, 3330, 3367 & 9760. System Code #728125, Serial #: 2501, 2505, 2508, 2509, 2513, 2515, 2516, 2522, 2523, 2524, 2525, 2526, 2529, 2530, 2531, 2533, 2534, 2535, 2539, 2540, 2542, 2543, 2548 & 2549.
Risk classification: Class II
Area (FDA): device
Country: United States

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