Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2013 - (Recall #: Z-0786-2013)

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.

Class II

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).

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.

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.

Voluntary: Firm initiated