OEC 9900 Systems with 9-inch Image Intensifier — FDA record Z-2277-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 15, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
OEC 9900 Systems with 9-inch Image Intensifier
Reason
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.
Classification
Class II
Recalling firm
GE OEC Medical Systems, Inc
Quantity
908
Agency-reported status
Ongoing
Source record identifier
Z-2277-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityUDI-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

Match all identifying details in the current notice. A brand name alone is not enough.

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Aug 9, 2023
Recall initiation date
May 15, 2023
Center classification date
Jul 31, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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