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Medium RiskFDA Device

GE OEC Medical Systems, Inc: Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.

Agency Publication Date: July 31, 2023
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Affected Products

Product: OEC Flexiview 8800 Systems with 9-inch Image Intensifier

Serial Numbers: 3228PU4, 6936PU9

Product: OEC 9800 Systems with 9-inch Image Intensifier

UDI-DI: 00840682114349. Serial Numbers: 89-0317, 89-0554, 8S-1293, 8S-0509, 8S-0108, 8S-1029, 8S-2836, 89-3028, 8S-1574, 89-0609-RC, 89-1308, 8S-0394, 89-0979, 8SXXXX03626, 8SXXXX03683, 8SXXXX03681, 8S-1894, 8S-0175, 8S-2988, 89-2459, 89-2101, 89-3245, 89-1623, 89-0296, 8S-0200, 8S-0748, 89-1590, 89-1713, 8S-0124, 89-0282, 8S-2580, 89-3132, 8S-3039, 89-3451, 89-0223, 89-1155, 8SXXXX03680, 8S-3278, 8S-2426, 89-2913, 8S-1167, 89-1278, 89-1854, 8S-0233-C, 8S-1926, 8SXXXX03682, 89-2167, 8S-1109, 8SXXXX03679, 8S-0410, 89-1579-N, 89-1920, 89-3102, 8S-2046-C, 89-2340, 89-0461, 89-3809, 89-3810

Product: OEC 9900 Systems with 9-inch Image Intensifier

UDI-DI: 00840682114301 Serial Numbers: ES-2700, ESXXXL00081, ESXXXL00104, ES-2873, ESXXXX04525, ESXXXX04526, ESXXXX04527, E9-2573, E9XXXX03024, ESXXXX04467, ES-2768, ESXXXX03911, ESXXXX04425, E9-2510, E9-2646, ES-3208, ES-3209, ES-2934, ES-2940, ESXXXX04391, ES-0662, ES-3216, ES-3217, E9-1266, E9-2330, ESXXXX04441, E9XXXX03364, ES-1631, ES-2835, ES-2846, ES-2987, ES-3179, ESXXXX04377, ES-2692, ES-2693, ES-2847, ES-2679, E9-1695, E9-1716, E9-1719, E9-2183, E9-2186, E9-2327, E9-2328, E9-2451, E9-2517, ES-3110, ESXXXX04365, ESXXXX04369, E9-2286, E9-2571, ESXXXX04472, ES-2647, ESXXXX04436, E9-2189, ES-2755, ESXXXX04475, E9-2645, ESXXXX04449, ES-2667, ESXXXX04435, E9XXXX03408, E9-2187, ES-2868, ESXXXX04394, ES-2981, ES-2942, ES-2965, ESXXXX04505, E9-2246, ES-2988, E9XXXX03336, ES-1548, ES-2948, ESXXXX04462, E9-0975, ES-3080, ESXXXX04061, ESXXXX04497, ESXXXX04465, ESXXXX04468, ESXXXX04489, E9-2562, ES-2953, ESXXXX04464, ESXXXX04488, ESXXXX04484, ES-2808, ES-2689, ES-2848, ES-2995, ESXXXL00057, ES-2849, ES-3090, ES-2836, E9XXXX03484, ESXXXX04447, ES-2978, ESXXXL00083, ESXXXX04530, ES-2640, ES-2865, ESXXXX04457, ES-2894, ES-3091, ES-3076, ES-2788, ESXXXX04460, ESXXXX04406, E9-2282, E9-2586, E9-2841, E9-2842, ESXXXX04376, E9-2498, E9-2305, E9XXXX03371, ES-2634, E9-2641, E9-0259, E9XXXX03456, E9-2655, E9-2663, E9XXXX03347, ESXXXL00067, ES-2786, ES-2947, ES-2973, ESXXXL00066, E9-2561, ES-1782, E9-0409, E9-2666, E9-2490, E9-2577, ES-3207, ES-3642, ESXXXL00080, ESXXXX04498, ESXXXX04502, E9-2584, E9-2644, ES-3086, ESXXXL00090, ESXXXX04495, E9-2402, E9XXXX03412, ES-3078, ES-2646, E9XXXX03366, ESXXXL00105, ESXXXL00093, ES-2669, ES-3182, E9-2662, ES-2950, ES-2966, ESXXXL00078, ES-2653, ES-2903, E9-2515, ESXXXX04402, ESXXXX04466, E9-2389, E9-2391, E9-2409, ES-3084, ESXXXL00084, ESXXXL00092, ESXXXL00100, ES-2864, ES-3210, ESXXXX04421, ES-2960, ESXXXX04440, E9XXXX03424, ES-2949-CH, ES-2699, ES-2633, E9XXXX03435, ESXXXX04511, E9-0950, E9-2196, E9-2839, ESXXXL00137, E9-2324, E9-2405, E9-2657, ES-2767, ES-2968, ES-2681, ES-3140, ES-2695, ESXXXX04483, ES-2837, E9-2559, ESXXXX04446, ES-2764, E9-2578, ESXXXX04418, ESXXXL00097, E9XXXX03414, E9XXXX03420, ES-2902, E9-2596, E9-2503, ES-2910, E9-1519, ES-3299, ES-2789, ES-3138, ES-3195, ES-2642, ES-2770, ES-2904, ESXXXX03863, ES-2961, ES-2639, ES-3082, ES-2982, E9-2650, ESXXXX04431, ESXXXX04474, ES-2807, ES-3064, ES-2993, ESXXXX04423, ES-3066, E9XXXX03430, E9XXXX03431, ES-3342, ES-2853, ES-2684, E9-2207, E9-2303, E9-2493, E9XXXX03403, E9XXXX03427, ES-2708, ES-3344, ESXXXX04368, ESXXXX04419, ES-2854, ES-3092, ES-2992, ES-3065, ESXXXX04478, ESXXXX04479, ES-0613, ES-3296, ES-3343, ES-2983, ES-2628, E9-2280, ESXXXX04379, ESXXXX04417, ES-2690, ES-3196, ES-3401, ESXXXX04444, ES-0306, ES-2939, E9-2659, ESXXXX04434, ESXXXX04378, E9-2660, E9XXXX03409, E9XXXX03418, E9XXXX03025, ES-2935, E9-2587, E9-2184, ES-2676, ES-2809, ES-2943, ES-2959, ES-2661, ESXXXX04422, ES-2958, E9-2347, ES-2678, ES-3131, ES-2980, E9-2502, E9-2522, ES-2916, E9XXXX03350, E9XXXX03354, ES-3077, E9-2593, ESXXXX04429, ES-2951, ESXXXL00058, ESXXXX04438, ESXXXX04531, E9-2653, ES-2664, ES-3111, ES-2855, ES-2874, ES-3166, ES-3192, ESXXXX04473, ES-2908, ES-2971, ESXXXX04506, E9-2325, E9XXXX03353, E9XXXX03370, ES-3189, E9-2311, ES-3062, E9-2197, E9-2834, E9-2836, ESXXXX04459, E9-2667, E9-0731, E9-2778, ES-2763, ESXXXX04529, E9-2678, ESXXXL00103, E9-2411, ES-2941, ES-3132, ES-2957, ESXXXX04517, ESXXXX04450, E9-2182, E9-2410, ES-2906, ES-2975, ES-2663, ESXXXX04437, E9-2665, ES-2641, ES-2688, ES-2745, ES-3211, ESXXXX04499, ESXXXX04367, ES-2790, E9-2837, ESCHXX90026, ESXXXX04426, E9-2452, E9-2453, ES-2762, ES-2944, ES-2945, ES-3187, ESXXXX04430, E9-0056, E9XXXX03496, ES-2771, ES-2662, ES-2677, ESXXXX04507, E9XXXX03163, ESXXXX04452, ES-2602, ES-2413, ES-2933, ES-3290, E9-2209, ES-2765, ESXXXL00071, ESXXXX04455, ESXXXL00059, ESXXXL00098, E9XXXX03348, ES-3073, E9-2585, E9XXXX03413, ES-1067, ES-2769, ESXXXX04445, E9-2591, E9-2656, ES-2824, ES-2905, ESXXXL00091, ESXXXX04469, ESXXXL00079, E9-2509, ESXXXX04403, ESXXXX04480, ESXXXL00102, E9-2664, ES-2986, ESXXXX04405, ES-3240, ES-2656, ES-2671, ESXXXL00074, ESXXXX04513, ES-3165, ES-2670, ES-3099, ESXXXX04461, ESXXXL00099, ESXXXL00070, ES-2850, ESXXXL00072, ES-3169, ESXXXL00060, ESXXXL00086, ESXXXL00088, ESXXXL00077, E9-2495, ES-2346, ESXXXL00082, ESXXXL00094, E9-2518, ES-3224, E9-0935, E9-2575, E9-2832, E9-2337, E9-2534, ESXXXL00106, E9-2535, ES-2654, ES-2851, ES-3133, ES-3298, E9-2581, ESXXXX04049, ES-7227-CMH, E9XXXX03001, ESXXXX04428, ES-2645, ESXXXX04404, E9-2519, E9-2661, E9-2385, E9-2564, ES-2956, ES-2731, ES-2472, ES-2976, E9XXXX03477, ESXXXX04392, ESXXXX04504, ESXXXX04512, ES-2955, ES-3538, ESXXXX04477, ES-3139, E9-2563, E9XXXX03352, E9-2497, E9XXXX03356, E9-0231, E9-2195, ES-3089, ES-3183, ESXXXX04496, ES-2962, ES-2963, ESXXXX04442, ESXXXX04424, ESXXXX04393, E9-2583, ES-2969, E9XXXX03349, ESXXXX04491, ESXXXX04493, ESXXXX04494, ESXXXX04519, ES-1598, ES-3190, ESXXXX04486, ESXXXX04487, E9-2256, E9-2582, ESXXXL00085, ESXXXX04508, E9-2579, ES-2996, E9-2594, ES-2683, ES-2858, E9-2899, ES-2756, ES-2774, ES-2937, ES-2761, ES-2867, ES-2694, ES-2655, ES-3063, ES-2964, ESXXXL00056, ES-2892, ES-2680, ES-3058, ES-3297, E9-2516, E9-2520, ES-2890, ES-2629, ESXXXX04514, ES-3152, ES-3153, ESXXXX04407, ESXXXX04427, ES-2649, ES-2773, ES-2776, ES-3255, ESXXXX04458, ESXXXX04470, E9-2190, ES-2668, ES-3745, E9-2285, E9-2566, ESXXXX04338, E9-2206, E9XXXX03425, ES-2659, E9-2565, ES-2866, ES-2869, E9-2201, E9-2202, E9-2499, E9XXXX03433, E9-2580, ESXXXL00069, E9-2203, E9-2204, ES-2686, ESXXXL00073, ES-2946, E9-2390, E9-2643, E9-2556, E9-2395, E9-2572, ES-3079, ES-3081, E9-2638, ESXXXX04485, E9-2679, ES-3300, ESXXXX04366, E9-2211, E9-2284, E9-2304, E9-2346, E9-2407, E9-2511, E9-2512, E9-2569, E9XXXX03485, ES-0080, ES-2652, ES-2954, ES-2997, ES-3598, ES-2775, E9-2831, ESXXXX04451, ES-2666, ES-2915, ES-3341, ES-3056, ES-1052, E9-2404, ES-2650, ES-3112, ES-3301, ESXXXX04453, ES-2665, E9-2398, E9-2399, E9-2318, E9-2392, ES-2691, ES-3204, ESXXXL00075, ESXXXL00076, ESXXXX04439, E9-2532, ES-2635, ES-3180, ES-2914, ES-2952, ESXXXX04509, ES-2787, ESXXXL00061, E9-2298, E9-2200, E9-2557, E9-2889, ES-2825, ES-2907, ES-3135, ES-3136, ES-3137, ESXXXX04501, E9-2245, E9-2297, ES-2754, E9-2296, E9-2523, ESXXXX04521, ES-3134, ES-2660, ESXXXX04448, ES-2994, ESXXXX04482, ESXXXX04443, E9-2329, E9-2397, E9-2401, E9-2640, E9-2642, E9-2652, E9XXXX03419, E9XXXX03493, ES-2648, ES-2687, ES-2772, ES-2834, ES-2909, ES-2972, ES-3074, ES-3215, ES-7307-CMH, ESXXXX04481, ESXXXX04492, ES-2685, ESXXXX04463, E9-2210, E9-2567, ES-3193, ES-3203, ES-3167, ESXXXL00087, ES-2810, E9XXXX03365, ES-2637, ES-2893, ES-3040, E9-2639, ES-2856, E9-2393, E9-2345, ESXXXL00089, E9XXXX03437, ESXXXX04516, ES-2970, E9-2185, E9XXXX03436, E9-2521, ES-2889, ESXXXX04370, ESXXXX04490, E9-2654, E9-2496, ES-2999, ES-3285, E9-2588, ES-2682, ES-2979, ES-2630, ES-2991, E9-2568, E9-2205, ES-3083, E9-2551, E9-2833, E9-2835, ES-3085, ES-3191, ES-3194, E9-2574, ES-2636, E9-2394, ES-2990, ES-3093, E9-2322, ESXXXX04420, ES-2967, ES-2974, ESXXXL00101, E9XXXX03006, ES-2651, ES-3188, ESXXXL00095, ESXXXL00096, ES-2998, E9XXXX03405, E9XXXX03404, ESCHXX90030, ES-7328-CMH, ES-7336-CMH, ESCHXX90051, ESCHXX90025, ESCHXX90049, E9XXXX03351, ES-2823, E9-2295, E9-2277, E9-2283, E9XXXX03460, E9XXXX03467, ESCMHX07474, ESCMHX07475, ESCHXX90035, ESCHXX90037, E9-2494, ESCHXX90034, ESCHXX90029, E9XXXX03372, ESCHXX90043, ESCHXX90042, E9XXXX03373, ESCHXX90033, ESCHXX90036, E9-2403, ES-2936, ES-3164, ESXXXX04515, ES-2698, E9-2208, E9-2514, ESXXXX04433, E9XXXX03407, E9-2491, ES-3163, ES-3213, ES-3214, E9-2293, E9-2492, E9-2648, E9-2651, E9XXXX03377, ES-3168, E9-2263, ES-7322-CMH, ES-7332-CMH, E9XXXX03423, ES-2938-CH, ES-7331-CMH, ES-7330-CMH, E9XXXX03428, ESCMHX07468, E9-2270, E9-2273, ESCMHX07478, ESCMHX07479, E9-2259, E9-2254, E9XXXX03406, ES-7168-CMH, E9-2252, E9-2271, E9-2272, ES-7323-CMH, ES-7335-CMH, E9-2275, E9-2274, E9XXXX03479, ES-7317-CMH, ESCMHX07465, ESCMHX07464, ES-7337-CMH, E9XXXX03495, ESCMHX07467, ESCMHX07462, ES-7326-CMH, ES-7316-CMH, ESCMHX07477, E9XXXX03468, E9XXXX03472, E9XXXX03473, E9XXXX03363, E9XXXX03469, E9XXXX03440, E9XXXX03476, E9XXXX03478, E9-2396, E9-2400, E9-2408, ES-3072-CH, E9-2570, E9-2255, E9-2253, E9-2290, E9-2288, E9-2289, E9-2294, E9-2406, E9-2501, E9-2748, ES-3069, ESXXXX04523, ESXXXX04524, ES-2985, E9-2488, E9-2261, E9-2508, ES-2891, E9-2506, E9-2500, ES-3075, E9-2507, E9XXXX03434, ES-2984, E9XXXX03426, E9-2589, E9-2838, ES-2852, E9-2560, ES-3450, ES-2870, ESXXXX04503, ES-3038, E9-2258, E9XXXX03005, E9-2262, E9XXXX03474, ESCHXX90039, ESCHXX90040, ESXXXX04380, ESXXXX04454, ESXXXX04476, ESXXXX04518, ESXXXX04520, ES-3070, E9-2533, ES-3068, ESXXXX04528, E9-2531, E9-2590, E9-2747, ES-2911, ES-3071, E9XXXX03475, ESXXXX04471, E9XXXX03359, E9XXXX03368, E9XXXX03491, E9XXXX03471, E9XXXX03415, E9XXXX03439, E9XXXX03357, E9XXXX03429, E9XXXX03470, E9XXXX03488, E9XXXX03490, E9XXXX03492, E9XXXX03494, ESXXXX04500, E9XXXX03487, E9-2317, E9XXXX03367, E9XXXX03416, E9XXXX03438, ES-7346-CMH, E9XXXX03466, E9-2257, ES-3087-CH, ESCHXX90041, E9-2302, ESCHXX90044, ESCHXX90047, ES-7325-CMH, ES-7348-CMH, ES-2977-CH, ES-1717-CH, ES-3088-CH, ESCHXX90045, ESCHXX90048, ESCHXX90046, ESCMHX07476, ESCMHX07466, E9-2279, E9XXXX03421, ESCHXX90053, ESCHXX90028, ESCHXX90052, ESCMHX07473, ESCHXX90032, ESCHXX90027, E9XXXX03459, ES-7324-CMH, E9XXXX03480, E9XXXX03481, ESXXXX04522, E9-2323, E9XXXX03417, ESCMHX07472, E9XXXX03369, E9XXXX03374, E9-2326, E9-2558, E9-2281, E9-2276, E9-2291, E9-2292, E9XXXX03486

Product: OEC Elite Systems with 9-inch Image Intensifier

UDI-DI: 00840682121729 Serial Numbers: FSXXTX00180, FSXXXX00020, F9XXTX00007, F9XXTX00008, F9XXXX00021, FSXXTX00068, FSXXTX00303, FSXXXX00054, FSXXTX00333, FSXXTX00272, F9XXXX00046, FSXXXX00009, FSXXXX00005, FSXXTX00350, F9XXTX00025, FSXXTX00131, FSXXTX00103, FSXXTX00116, FSXXTX00073, FSXXXX00056, FSXXTX00120, FSXXTX00171, FSXXTX00307, FSXXXX00006, FSXXTX00153, FSXXTX00154, FSXXTX00214, FSXXTX00048, FSXXTX00062, FSXXTX00170, FSXXTX00172, FSXXTX00362, FSXXTX00368, FSXXXX00024, F9XXTX00202, FSXXTX00326, FSXXTX00260, FSXXTX00133, FSXXXX00011, FSXXTX00286, F9XXTX00045, FSXXTX00241, FSXXTX00179, FSXXTX00276, FSXXTX00396, FSXXTX00034, FSXXTX00359, FSXXTX00248, FSXXXX00057, FSXXTX00079, FSXXTX00274, FSXXXX00032, FSXXTX00331, FSXXTX00042, FSXXTX00114, FSXXXX00007, FSXXTX00345, FSXXTX00065, FSXXTX00173, FSXXTX00191, FSXXTX00123, FSXXTX00376, F9XXTX00238, FSXXTX00234, FSXXTX00107, FSXXTX00298, F9XXXX00050, FSXXXX00036, FSXXXX00039, FSXXTX00373, FSXXTX00338, FSXXTX00382, FSXXTX00045, FSXXTX00118, F9XXTX00155, F9XXTX00179, FSXXTX00305, F9XXTX00053, FSXXTX00119, FSXXTX00135, FSXXTX00136, FSXXTX00221, FSXXXX00063, FSXXTX00067, FSXXTX00244, FSXXXX00062, FSXXTX00060, F9XXTX00059, FSXXTX00204, F9XXTX00040, FSXXTX00036, FSXXTX00099, F9XXTX00149, F9XXXX00013, F9XXXX00028, F9XXTX00019, FSXXTX00327, F9XXTX00017, F9XXTX00018, FSXXTX00216, FSXXTX00414, FSXXTX00315, FSXXTX00209, F9XXTX00121, F9XXTX00153, FSXXTX00027, FSXXTX00158, FSXXTX00231, FSXXTX00405, FSXXTX00406, FSXXTX00072, F9XXTX00030, FSXXTX00413, F9XXTX00196, F9XXTX00157, F9XXTX00158, F9XXTX00241, F9XXTX00248, FSXXTX00053, FSXXTX00054, FSXXTX00323, FSXXXX00010, FSXXTX00407, FSXXTX00049, FSXXTX00193, FSXXTX00220, FSXXTX00149, FSXXTX00150, FSXXTX00208, FSXXTX00168, FSXXTX00240, FSXXXX00061, FSXXTX00029, FSXXXX00045, FSXXXX00049, F9XXTX00220, F9XXTX00226, F9XXTX00127, FSXXTX00178, FSXXXX00017, FSXXTX00316, FSXXXX00023, FSXXTX00108, FSXXTX00330, FSXXXX00008, FSXXXX00052, FSXXTX00177, FSXXXX00048, FSXXTX00037, FSXXTX00278, FSXXTX00280, FSXXXX00035, F9XXXX00060, F9XXXX00038, F9XXXX00039, FSXXTX00102, FSXXTX00098, F9XXTX00081, FSXXTX00165, FSXXTX00057, FSXXTX00088, FSXXTX00197, FSXXTX00198, FSXXTX00412, FSXXTX00013, FSXXTX00014, FSXXTX00015, FSXXTX00016, FSXXTX00047, FSXXTX00337, FSXXTX00003, FSXXTX00189, FSXXXX00018, FSXXXX00019, FSXXTX00223, FSXXTX00306, FSXXTX00129, F9XXTX00071, FSXXTX00091, FSXXTX00166, FSXXTX00106, FSXXTX00117, FSXXTX00217, F9XXTX00198, FSXXTX00033, FSXXTX00109, FSXXTX00141, FSXXTX00282, FSXXTX00328, FSXXTX00341, FSXXTX00347, FSXXXX00003, FSXXTX00277, F9XXTX00180, F9XXXX00018, F9XXXX00020, F9XXXX00041, F9XXXX00042, F9XXTX00174, FSXXTX00090, F9XXXX00066, FSXXTX00010, FSXXTX00302, FSXXTX00146, FSXXTX00121, F9XXTX00020, F9XXTX00063, F9XXTX00064, FSXXTX00270, FSXXTX00322, F9XXTX00048, FSXXTX00294, FSXXTX00258, FSXXTX00259, FSXXTX00159, F9XXTX00188, FSXXTX00218, FSXXTX00230, F9XXTX00251, FSXXTX00319, F9XXXX00068, FSXXXX00064, FSXXTX00087, F9XXTX00023, F9XXXX00067, FSXXTX00264, FSXXXX00001, FSXXXX00059, FSXXTX00233, FSXXTX00398, FSXXTX00364, FSXXTX00339, FSXXTX00365, FSXXTX00349, F9XXTX00195, FSXXTX00283, FSXXTX00325, F9XXTX00111, F9XXTX00113, F9XXTX00244, F9XXTX00253, FSXXTX00012, FSXXTX00059, F9XXTX00154, FSXXTX00143, FSXXTX00186, FSXXTX00267, FSXXTX00271, FSXXTX00344, FSXXTX00055, FSXXTX00128, F9XXTX00231, FSXXTX00212, FSXXTX00355, F9XXXX00043, FSXXTX00066, FSXXTX00321, FSXXXX00043, F9XXTX00146, F9XXTX00201, F9XXTX00024, F9XXXX00019, FSXXTX00390, FSXXTX00096, FSXXTX00384, FSXXXX00021, FSXXTX00367, FSXXTX00155, FSXXTX00138, FSXXTX00207, FSXXTX00232, FSXXTX00236, F9XXTX00010, F9XXTX00011, F9XXTX00039, F9XXTX00181, F9XXXX00012, F9XXXX00014, FSXXTX00006, FSXXTX00009, FSXXTX00132, FSXXTX00265, FSXXTX00395, FSXXTX00239, FSXXTX00190, FSXXTX00052, FSXXTX00249, FSXXTX00004, FSXXTX00031, FSXXTX00032, FSXXTX00127, FSXXTX00343, FSXXTX00354, F9XXTX00137, F9XXTX00147, FSXXTX00295, F9XXTX00082, F9XXTX00044, FSXXTX00360, FSXXTX00374, F9XXTX00257, F9XXTX00112, F9XXTX00156, F9XXTX00085, FSXXTX00224, F9XXTX00159, FSXXTX00074, FSXXXX00066, FSXXTX00358, F9XXXX00051, FSXXTX00242, FSXXTX00213, FSXXXX00041, FSXXXX00053, F9XXTX00239, F9XXXX00036, FSXXTX00038, FSXXTX00317, F9XXTX00197, F9XXTX00041, F9XXTX00150, FSXXXX00027, FSXXTX00007, FSXXTX00332, FSXXTX00389, F9XXTX00107, FSXXTX00175, FSXXTX00195, FSXXTX00008, FSXXXX00033, FSXXTX00039, FSXXTX00030, FSXXTX00289, FSXXXX00026, F9XXTX00016, FSXXTX00163, FSXXTX00187, FSXXTX00261, FSXXTX00161, FSXXTX00100, FSXXTX00101, FSXXTX00095, FSXXTX00329, F9XXXX00037, F9XXTX00254, FSXXTX00263, F9XXXX00040, FSXXTX00071, FSXXXX00040, FSXXTX00035, FSXXTX00182, F9XXTX00177, FSXXXX00058, FSXXTX00352, FSXXTX00093, FSXXTX00082, FSXXTX00222, FSXXTX00112, F9XXTX00043, FSXXTX00069, FSXXTX00130, FSXXTX00134, FSXXTX00194, FSXXTX00199, FSXXTX00304, FSXXTX00125, FSXXTX00126, FSXXTX00361, FSXXTX00162, FSXXTX00288, FSXXTX00293, F9XXTX00009, F9XXXX00047, FSXXTX00342, FSXXTX00392, F9XXTX00218, F9XXTX00240, FSXXTX00185, F9XXTX00216, FSXXTX00061, FSXXTX00089, FSXXTX00144, 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FSXXTX00422, FSXXTX00086, FSXXTX00104, FSXXTX00056, F9XXXX00034, FSXXTX00169, F9XXTX00126, FSXXXX00013, FSXXXX00015, FSXXTX00351, FSXXXX00037, FSXXTX00300, FSXXTX00348, FSXXTX00391, FSXXTX00281, FSXXXX00038, FSXXTX00418, FSXXXX00044, FSXXTX00094, FSXXTX00097, F9XXTX00145, F9XXTX00200, F9XXXX00035, F9XXTX00021, F9XXTX00022, FSXXXX00002, FSXXTX00078, FSXXTX00070, FSXXTX00393, FSXXTX00105, FSXXXX00028, FSXXXX00031, F9XXTX00095, F9XXTX00255, FSXXXX00022, F9XXTX00123, F9XXTX00088, F9XXTX00087, FSXXTX00310, F9XXTX00199, F9XXTX00056, F9XXTX00069, FSXXTX00111, FSXXTX00077, F9XXTX00172, F9XXTX00185, F9XXTX00191, F9XXTX00205, F9XXTX00259, FSXXTX00369, F9XXTX00003, F9XXTX00058, F9XXTX00089, F9XXTX00094, F9XXTX00116, F9XXXX00048, FSXXXX00046, F9XXTX00100, F9XXXX00061, F9XXXX00001, F9XXTX00050, F9XXXX00032, F9XXXX00069, F9XXTX00194, F9XXTX00230, F9XXTX00252, F9XXTX00035, F9XXTX00036, F9XXTX00049, F9XXTX00142, F9XXTX00222, F9XXTX00232, F9XXXX00016, FSXXTX00021, FSXXTX00023, FSXXTX00024, FSXXTX00400, FSXXTX00022, FSXXTX00083, FSXXTX00160, F9XXXX00062, F9XXXX00063, FSXXTX00225, FSXXTX00257, FSXXTX00388, FSXXTX00176, FSXXTX00256, FSXXTX00380, FSXXTX00050, FSXXTX00205, FSXXTX00025, F9XXTX00171, FSXXTX00147, FSXXTX00403, F9XXTX00014, F9XXTX00029, F9XXTX00108, F9XXTX00130, F9XXTX00131, F9XXXX00064, F9XXTX00073, F9XXTX00074, F9XXTX00075, F9XXTX00028, F9XXTX00167, F9XXTX00135, F9XXTX00204, F9XXTX00152, F9XXXX00003, F9XXXX00007, FSXXXX00030, F9XXTX00057, FSXXTX00075, FSXXTX00018, F9XXTX00246, F9XXTX00213, F9XXTX00076, F9XXTX00224, F9XXTX00245, F9XXXX00044, F9XXXX00029, F9XXXX00022, F9XXXX00011, F9XXXX00008, FSXXTX00020, F9XXXX00025, F9XXTX00170, FSXXTX00152, F9XXTX00106, F9XXTX00139, FSXXTX00312, FSXXTX00252, FSXXXX00012, FSXXTX00081, FSXXTX00145, FSXXTX00151, FSXXXX00060, F9XXTX00203, FSXXTX00311, FSXXTX00378, FSXXTX00401, FSXXTX00402, FSXXTX00421, FSXXTX00076, F9XXTX00083, FSXXTX00206, FSXXTX00080, FSXXTX00229, F9XXTX00209, F9XXTX00208, F9XXTX00054, F9XXTX00065, F9XXTX00173, F9XXTX00193, 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F9XXTX00104, F9XXXX00015, F9XXXX00017, F9XXTX00061, F9XXTX00166, F9XXTX00052, F9XXTX00026, F9XXTX00183, FSXXTX00251, F9XXTX00060, F9XXTX00189, F9XXTX00211, F9XXXX00006, F9XXXX00031, F9XXTX00034, F9XXTX00055, F9XXTX00249, F9XXTX00101, F9XXTX00102, F9XXTX00110, F9XXTX00119, F9XXTX00090, F9XXTX00091, F9XXTX00092, F9XXTX00210, F9XXXX00009, F9XXXX00010, F9XXTX00169, F9XXTX00051, F9XXTX00118, F9XXTX00120, FSXXTX00291, F9XXTX00247, F9XXTX00032, FSXXTX00255, F9XXTX00182, F9XXXX00030, F9XXTX00033, F9XXTX00047, F9XXTX00124, F9XXTX00168, F9XXTX00250, F9XXXX00026, F9XXTX00229, F9XXTX00163

Product: Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems

P/N/Sales Order Number: 5451208/80165102, 80171955, 80173514, 80162453, 80183950, 80151733, 80163547, 80171532, 80156410, 80176650, 10530514, 105449333, 80167595; 5485304/10557644, 118687327; 5761613/10283014, 10152211, 105108003, 105114645. OEC 9800, UDI-DI: 00840682114349; OEC 9900 Systems, UDI-DI: 00840682114301

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92504
Status: Active
Manufacturer: GE OEC Medical Systems, Inc
Manufactured In: United States
Units Affected: 5 products (2; 58; 908; 812; 16)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.