Retiro De Equipo (Recall) de Mx8000 IDT Whole Body Computed Tomography Xray system

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Philips Medical Systems (Cleveland) Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    63392
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0786-2013
  • Fecha de inicio del evento
    2012-09-18
  • Fecha de publicación del evento
    2013-02-26
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2015-09-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, x-ray, tomography, computed - Product Code JAK
  • Causa
    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).
  • Acción
    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.

Device

  • Modelo / Serial
    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.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA