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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance CT

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  Class 2 Device Recall Brilliance CT see related information
Date Initiated by Firm March 12, 2013
Date Posted May 20, 2013
Recall Status1 Terminated 3 on June 30, 2015
Recall Number Z-1338-2013
Recall Event ID 64713
510(K)Number K012009  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Customer Care Solutions Center
800-722-9377
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Use error
Action The firm, Philips Healthcare, sent an "Urgent - Medical Device Correction" letter dated March 15, 2013, to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to disregard unusually higher CTDIvol value for Type-3 DICOM tag 0018:9345 in the PACS system, if seen. The firm is implementing software update versions 4.2.2 or 2.2.2 to correct the issue. A Philips Field Service Engineer will contact you to schedule the software installation at your site. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customers Care Solutions Center (1-800-722-9377, Option 5: Enter Site ID or follow the prompts).
Quantity in Commerce 515 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = MARCONI MEDICAL SYSTEMS, INC.
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