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U.S. Department of Health and Human Services

Class 2 Device Recall Mx8000 IDT Whole Body Computed Tomography Xray system

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 Class 2 Recall
Mx8000 IDT Whole Body Computed Tomography Xray system
see related information
Date Posted February 26, 2013
Recall Status1 Open
Recall Number Z-0786-2013
Recall Event ID 63392
Premarket Notification
510(K) Number
K012009 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Code Information 1. Brilliance CT 16 slice (water): System Code #, 728245, Serial #s:2506, 2518, 2555, 2558, 2559, 2561, 2561, 2562, 2564, 2567, 2573, 2576, 2578, 2582, 2583, 2584, 2585, 2586, 2587, 2589, 2590, 2592, 2594, 2596, 2597, 3014, 3051, 3090, 3091, 3105, 3151, 3217, 3235, 3272, 3287, 3303, 3312, 3335, 3338, 3339, 3340, 3341, 3342, 3343, 3344, 3345, 3346, 3347, 3348, 3349, 3350, 3351, 3352, 3353, 3354, 3355, 3356, 3357, 3358, 3359, 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, 3401, 3402, 3403, 3404, 3405, 3406, 3407, 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, 3435, 3436, 3437, 3438, 3439, 3440, 3441, 3442, 3443, 3444, 3445, 3446, 3447, 3448, 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, 5010, 5077, 5119, 6095, 9701, 9708, 9715, 9716, 9718, 9719, 9724, 9728, 9729, 9732, 9741, 9743, 9745, 9746, 9749, 9750, 9754, 9760, 9764, 9771, 9776, 9778, 9780, 9785, 9787, 9788, 9789, 9790, 9794, 9797, 9800, 9801, 9806, 9808, 9810, 9999 & 111111. 2. Brilliance CT 10 slice (water): System Code #, 728250, Serial #s: 2554, 2555, 2556, 2557, 2558, 2559, 2560, 2561, 2562, 2563, 2564, 2565, 2566, 2567, 2568, 2569, 2570, 2571, 2572, 2573, 2574, 2575, 2576, 2577, 2578, 2579, 2580, 2581, 2582, 2583, 2585, 2586, 2587, 2588, 2589, 2590, 2591, 2592, 2593, 2594, 2595, 2596, 2597, 2598, 9704, 9708, 9738 & 9741. 3. Brilliance CT 6 slice (water): System Code #, 728255, Serial #s: 2565, 9701, 9702, 9703, 9704, 9705, 9706, 9707, 9708, 9709, 9710, 9711, 9712, 9713, 9714, 9715, 9716, 9717, 9718, 9719, 9720, 9721, 9722, 9723, 9724, 9725, 9726, 9727, 9728, 9729, 9730, 9731, 9732, 9733, 9734, 9735, 9736, 9737, 9738, 9739, 9740, 9741, 9742, 9743, 9744, 9745, 9746, 9747, 9748, 9749, 9750, 9751, 9752, 9753, 9754, 9755, 9756, 9757, 9758, 9759, 9760, 9761, 9762, 9763, 9764, 9765, 9766, 9767, 9768, 9769, 9770, 9771, 9772, 9773, 9774, 9775, 9776, 9777, 9778, 9779, 9780, 9781, 9782, 9783, 9784, 9785, 9786, 9787, 9788, 9789, 9790, 9791, 9792, 9793, 9794, 9795, 9796, 9797, 9798, 9799, 9800, 9801, 9802, 9803, 9804, 9805, 9806, 9807, 9808, 9810 & 111111. 4. Mx8000 IDT 16 slice System Code #, 728120, Serial #, Serial #s: 1225, 2059, 2345, 2501, 2502, 2506, 2510, 2511, 2513, 2516, 2517, 2518, 2520, 2525, 2528, 2531, 2533, 2535, 2537, 2539, 2546, 2550, 3002, 3006, 3007, 3008, 3012, 3013, 3014, 3017, 3019, 3020, 3021, 3022, 3023, 3024, 3025, 3026, 3027, 3028, 3029, 3030, 3031, 3032, 3034, 3035, 3036, 3037, 3038, 3039, 3040, 3041, 3042, 3043, 3044, 3045, 3046, 3047, 3048, 3049, 3050, 3051, 3052, 3053, 3054, 3055, 3056, 3057, 3058, 3059, 3060, 3061, 3062, 3063, 3064, 3065, 3066, 3067, 3068, 3069, 3070, 3071, 3072, 3073, 3074, 3075, 3076, 3077, 3078, 3079, 3082, 3083, 3084, 3085, 3086, 3087, 3088, 3089, 3090, 3091, 3092, 3093, 3094, 3095, 3096, 3097, 3098, 3099, 3100, 3101, 3102, 3103, 3104, 3105, 3106, 3107, 3108, 3109, 3110, 3111, 3112, 3113, 3114, 3115, 3116, 3117, 3118, 3119, 3120, 3121, 3122, 3123, 3124, 3125, 3126, 3127, 3128, 3129, 3130, 3131, 3132, 3133, 3134, 3135, 3136, 3137, 3138, 3139, 3140, 3141, 3143, 3144, 3145, 3146, 3147, 3148, 3149, 3150, 3151, 3152, 3153, 3154, 3155, 3156, 3157, 3158, 3159, 3160, 3161, 3162, 3163, 3164, 3165, 3167, 3168, 3169, 3170, 3171, 3172, 3173, 3174, 3175, 3176, 3177, 3178, 3179, 3180, 3181, 3182, 3183, 3184, 3185, 3186, 3187, 3188, 3189, 3190, 3191, 3192, 3193, 3194, 3195, 3196, 3197, 3198, 3199, 3200, 3201, 3202, 3203, 3204, 3205, 3206, 3207, 3208, 3209, 3210, 3211, 3212, 3213, 3214, 3215, 3216, 3217, 3218, 3219, 3220, 3221, 3222, 3223, 3224, 3225, 3226, 3227, 3228, 3229, 3230, 3231, 3232, 3233, 3234, 3235, 3236, 3237, 3238, 3239, 3240, 3241, 3242, 3243, 3244, 3245, 3246, 3247, 3248, 3249, 3250, 3251, 3252, 3253, 3254, 3255, 3256, 3257, 3258, 3259, 3260, 3261, 3262, 3263, 3264, 3265, 3266, 3267, 3268, 3269, 3270, 3271, 3272, 3273, 3274, 3275, 3276, 3277, 3278, 3279, 3280, 3281, 3282, 3283, 3284, 3285, 3286, 3287, 3288, 3289, 3290, 3291, 3292, 3293, 3294, 3295, 3296, 3297, 3298, 3299, 3300, 3301, 3302, 3303, 3304, 3305, 3306, 3307, 3308, 3309, 3310, 3311, 3312, 3313, 3314, 3315, 3316, 3317, 3318, 3319, 3320, 3321, 3322, 3323, 3324, 3325, 3326, 3327, 3328, 3329, 3330, 3333, 3336, 3367, 3420, 3480, 4111, 4112, 4114, 4115, 4116, 4117, 4444, 4445, 4446, 4447, 4567, 4799, 5005, 5006, 5007, 5008, 5009, 5011, 5012, 5013, 5014, 5555, 5678, 8888, 9760, 9789, 9900, 9991, 9995, 9997, 9999, 11111, 80159 & 111111. 5. Mx8000 IDT 10 slice: System Code #, 728125, Serial #s: 1225, 1234, 2501, 2502, 2503, 2504, 2505, 2506, 2507, 2508, 2509, 2510, 2511, 2512, 2513, 2514, 2515, 2516, 2517, 2518, 2519, 2520, 2521, 2522, 2523, 2524, 2525, 2526, 2527, 2528, 2529, 2530, 2531, 2532, 2533, 2534, 2535, 2536, 2537, 2538, 2539, 2540, 2541, 2542, 2543, 2544, 2546, 2547, 2548, 2549, 2550, 2551, 2552, 3018, 9999 & 111111. 6. Mx8000 Quad: System Code #, 728200, Serial #s: 2008, 2009, 2011, 2014, 2017, 2022, 2023, 2025, 2027, 2029, 2030, 2031, 2032, 2034, 2035, 2037, 2038, 2041, 2042, 2044, 2045, 2046, 2047, 2048, 2050, 2051, 2055, 2056, 2058, 2059, 2061, 2062, 2063, 2064, 2065, 2068, 2073, 2074, 2075, 2080, 2081, 2084, 2085, 2086, 2089, 2092, 2093, 2095, 2096, 2099, 2100, 2101, 2102, 2103, 2104, 2105, 2109, 2116, 2123, 2125, 2126, 2127, 2128, 2129, 2131, 2132, 2134, 2135, 2136, 2137, 2138, 2139, 2140, 2141, 2142, 2150, 2151, 2152, 2155, 2156, 2158, 2159, 2161, 8118, 9124, 204935 & 2020-1. 7. Mx8000 Dual: System Code #, 728201, Serial #s: 4288, 9000, 9005, 9006, 9008, 9010, 9011, 9012, 9015, 9018, 9020, 9021, 9025, 9027, 9035, 9036, 9037, 9038, 9039, 9042, 9049, 9050, 9055, 9056, 9058, 9059, 9061, 9062, 9063, 9068, 9072, 9076, 9077, 9080, 9084, 9085, 9089, 9090, 9091, 9093, 9094, 9096, 9098, 9103, 9105, 9106, 9108, 9109, 9110, 9120, 9121, 9125, 9131, 9133, 9135, 9136, 9137, 9138, 9139, 9143, 9144, 9146, 9148, 9151, 9155, 9160, 9163, 9169, 9173, 9174, 9175, 9179, 9182, 9184, 9187, 9188, 9194, 9195, 9196, 9197, 9198, 9199, 9200, 9201, 9202, 9205, 9208, 9210, 9211, 9212, 9219, 9220, 9222, 9228, 9231, 9232, 9239, 9240, 9241, 9242, 9249, 9250, 9254, 9257, 9258, 9259, 9260, 9261, 9262, 9266, 9267, 9269, 9270, 9271, 9272, 9273, 9274, 9278, 9279, 9280, 9281, 9284, 9285, 9288, 9290, 9292, 9294, 9295, 9296, 9297, 9299, 9300, 9301, 9307, 9308, 9317, 9320, 9324, 9327, 9328, 9331, 9332, 9334, 9336, 9339, 9351, 9352, 9354, 9357, 9361, 9362, 9363, 9364, 9365, 9367, 9368, 9369, 9370, 9372, 9376, 9377, 9378, 9380, 9384, 9387, 9396, 9397, 9405, 9407, 9411, 9412, 9417, 9423, 9426, 9427, 9428, 9429, 9431, 9433, 9445, 9446, 9447, 9465, 9466, 9467, 9469, 9471, 9472, 9473, 9474, 9476, 9477, 9482, 9483, 9484, 9487, 9488, 9489, 9490, 9493, 9496, 9497, 9500, 9509, 9510, 9515, 9521, 9522, 9529, 9530, 9532, 9537, 9538, 9539, 9540, 9541, 9542, 9543, 9544, 9549, 9551, 9552, 9553, 9555, 9561, 9563, 9574, 9576, 9577, 9584, 9585, 9588, 9592, 9593, 9598, 9599, 9600, 9601, 9603, 9606, 225637, 226925, 235225, 238067, 999030, 9122A, 9347A, 9361-1 & 9586-1. 8. Mx8000 Dual exp: System Code #, 728130, Serial #, Serial #s: 2110, 3291, 6005, 8008, 8010, 8014, 8016, 8018, 8021, 8023, 8025, 8034, 8035, 8039, 8040, 8041, 8043, 8046, 8048, 8053, 8054, 8055, 8056, 8057, 8058, 8061, 8064, 8065, 8066, 8067, 8068, 8070, 8073, 8074, 8075, 8076, 8077, 8078, 8079, 8080, 8081, 8082, 8083, 8084, 8085, 8086, 8091, 8092, 8095, 8096, 8097, 8098, 8102, 8103, 8104, 8105, 8106, 8107, 8108, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, 8119, 8120, 8122, 8123, 8124, 8125, 8126, 8127, 8128, 8129, 8130, 8131, 8132, 8134, 8135, 8136, 8137, 8138, 8139, 8140, 8142, 8143, 8144, 8145, 8146, 8147, 8149, 8150, 8151, 8152, 8153, 8154, 8155, 8156, 8157, 8158, 8159, 8160, 8162, 8163, 8164, 8165, 8166, 8167, 8168, 8169, 8171, 8172, 8173, 8174, 8175, 8176, 8177, 8178, 8180, 8181, 8183, 8184, 8185, 8186, 8187, 8188, 8190, 8191, 8192, 8193, 8194, 8195, 8196, 8197, 8198, 8199, 8200, 8201, 8202, 8203, 8204, 8205, 8206, 8207, 8208, 8210, 8211, 8212, 8213, 8215, 8216, 8217, 8218, 8219, 8220, 8221, 8222, 8223, 8224, 8225, 8226, 8227, 8228, 8229, 8230, 8232, 8233, 8234, 8235, 8236, 8237, 8238, 8239, 8240, 8242, 8243, 8244, 8245, 8246, 8247, 8248, 8249, 8250, 8253, 8254, 8255, 8256, 8257, 8258, 8259, 8260, 8261, 8262, 8263, 8264, 8265, 8266, 8267, 8268, 8269, 8270, 8271, 8272, 8273, 8274, 8275, 8276, 8277, 8278, 8279, 8280, 8281, 8282, 8283, 8284, 8285, 8286, 8287, 8288, 8289, 8290, 8291, 8292, 8293, 8294, 8295, 8296, 8297, 8298, 8299, 8300, 8301, 8302, 8303, 8304, 8305, 8306, 8307, 8308, 8309, 8310, 8311, 8312, 8313, 8314, 8315, 8316, 8317, 8318, 8319, 8320, 8321, 8322, 8323, 8324, 8325, 8326, 8327, 8328, 8329, 8330, 8331, 8332, 8333, 8334, 8335, 8336, 8337, 8338, 8339, 8340, 8341, 8342, 8343, 8344, 8345, 8346, 8347, 8349, 8350, 8351, 8352, 8353, 8354, 8355, 8356, 8357, 8358, 8359, 8360, 8361, 8362, 8363, 8364, 8365, 8366, 8367, 8368, 8369, 8370, 8371, 8372, 8373, 8374, 8375, 8376, 8377, 8378, 8379, 8380, 8381, 8382, 8383, 8384, 8385, 8386, 8387, 8388, 8389, 8390, 8391, 8392, 8393, 8394, 8395, 8396, 8398, 8400, 8401, 8402, 8403, 8404, 8405, 8406, 8407, 8409, 8410, 8411, 8412, 8413, 8442, 9528, 80002, 80003, 80004, 80005, 80007, 80009, 80010, 80011, 80012, 80013, 80014, 80015, 80016, 80017, 80018, 80019, 80021 & 80022.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland, Ohio 44143-2131
Consumer Instructions No consumer action necessary
For Additional Information Contact Kumudini J. Carter
440-483-3932
Manufacturer Reason
for Recall
The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents the customers from doing the Daily Image Quality Checks as defined in the current Instructions for Use (IfU).
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
Action Philips sent a Urgent Medical Device Recall Notice letter dated September 19, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken. This issue does not effect the performance of the Scanner. The Customer Information is intended to inform you about: 1. What the problem is and under what circumstances it can occur. 2. The action you as a customer can take to minimize the effect of this problem. 3 The action planned by Philips to correct this problem. If you need any further information or support concerning this issue please contact your local Philips Representative. In the US and Canada please contact the Philip's Healthcare customer care solutions at 1-800-722-9377, and follow the recorded menu options to reach a Customer Solutions Engineer. In all other countries please contact your local Philips Healthcare office.
Quantity in Commerce 1,474 Units
Distribution Worldwide Distribution - USA ( nationwide) including the states of AK, AL, AR, AZ, CA, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, VA, WA, WV and WY, and the countries of Albania, Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Canada, China, Colombia, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Ghana, Gibraltar, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Venezuela, Viet Nam & Yemen.
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.
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