—#113677

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.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: 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.

Why it was recalled

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).

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2012-09-18
Posted by FDA: 2013-02-26
Terminated: 2015-09-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #113677. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.