OEC 9900 Systems with 9-inch Image Intensifier recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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 9900 Systems with 9-inch Image Intensifier

Recalling firm

GE OEC Medical Systems, Inc

Quantity

908

Distribution

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina Faso, Canada, Chile, Colombia, Czechia, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, France, Georgia, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, KOREA, Malaysia, Mauritius, Mexico, Mongolia, Morocco, Nepal, New Caledonia, New Zealand, Nigeria, Paraguay, Peru, Poland, Portugal, Romania, Russia, Singapore, Spain, Switzerland, Taiwan, Tanzania, Thailand, Trinidad and Tobago, United Arab Emirates, United Kingdom, Uruguay, Vietnam.

Recall date

August 9, 2023

Classification

Class II

Status

Ongoing

Agency

FDA (device)