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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Philips Medical Systems (Cleveland) Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1338-2013
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