Use caution Medical device recall · FDA · Published May 15, 2023

GE OEC OEC Flexiv: 9-inch Image Intensifier May Detach and Cause Injury

GE OEC recalls OEC Flexiview 8800 systems with 9-inch image intensifiers that may detach during movement, risking fractures and bruising. Affected units have specific serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2275-2023Medical device GE OEC ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmGE OEC Medical Systems, Inc384 N Wright Brothers Dr · Salt Lake City, UT 84116-2862

✎ GovInfoNow plain-language explainer

GE OEC is recalling OEC Flexiview 8800 systems with 9-inch image intensifiers because they can detach if the system is moved hard, potentially causing injuries like fractures or bruising. This is a safety risk for medical staff using the equipment. Read more at govinfonow.com/recall/58267-ge-oec-oec-flexiv-9-inch-image-intensifier-may-detach.

Source Summary by GovInfoNow · govinfonow.com/recall/58267-ge-oec-oec-flexiv-9-inch-image-intensifier-may-detach · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2275-2023

Cite this page

“GE OEC OEC Flexiv: 9-inch Image Intensifier May Detach and Cause Injury.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/58267-ge-oec-oec-flexiv-9-inch-image-intensifier-may-detach. Based on FDA recall #Z-2275-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2275-2023%22&limit=1).

GE OEC Medical Systems, Inc. recalled OEC Flexiview 8800 Systems with 9-inch Image Intensifiers on May 15, 2023, according to the FDA. The image intensifiers may detach upon impact and fall, potentially causing injuries. Two units were distributed worldwide.

How to tell if you have it

Brand: GE OEC
Product: OEC Flexiview 8800 Systems with 9-inch Image Intensifier
Serial Numbers: 3228PU4, 6936PU9

The hazard

The image intensifiers on the systems can become detached if the units encounter a large impact force when moved. This may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, or pain.

Context

GovInfoNow's records show GE OEC Medical Systems, Inc. has issued two other recalls since June 10, 2021. On Nov. 21, 2024, the company recalled the GE OEC 3D REF Mobile Fluoroscopy System due to a potential oil leak risk. Other recent recalls of similar products include the GE Maxxus Nuclear Medicine Systems Recall (Dec. 10, 2025) and the GE Optima XR200amx Mobile Radiography System Recall (June 5, 2026).

How to tell if you have this one

Check if your OEC Flexiview 8800 system has a 9-inch image intensifier. Affected units include specific serial numbers: 3228PU4 and 6936PU9.

Brand
GE OEC
Category
Medical device

FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
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 number	Product, codes & lots	Quantity
Z-2275-2023	OEC Flexiview 8800 Systems with 9-inch Image Intensifier; Serial Numbers: 3228PU4, 6936PU9	2
Z-2276-2023	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	58
Z-2277-2023	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	908
Z-2278-2023	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, 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F9XXTX00175, F9XXTX00178, F9XXTX00190, FSXXTX00203, FSXXTX00357, FSXXXX00055, F9XXTX00037, F9XXXX00023, F9XXXX00027, F9XXTX00098, F9XXTX00105, F9XXXX00049, FSXXTX00279, FSXXTX00290, FSXXTX00028, FSXXTX00219, FSXXTX00266, FSXXXX00025, F9XXXX00045, FSXXXX00050, FSXXTX00200, FSXXTX00371, FSXXTX00318, FSXXTX00385, FSXXXX00016, FSXXTX00245, FSXXTX00246, FSXXTX00292, FSXXTX00409, FSXXTX00419, FSXXTX00309, FSXXTX00334, F9XXTX00125, F9XXTX00097, F9XXTX00228, F9XXTX00038, FSXXTX00297, FSXXTX00408, FSXXTX00383, FSXXTX00247, FSXXTX00356, FSXXTX00399, FSXXTX00115, F9XXXX00065, FSXXXX00042, F9XXTX00078, F9XXTX00148, F9XXTX00221, F9XXTX00235, F9XXTX00236, FSXXTX00051, FSXXTX00058, FSXXTX00377, FSXXTX00387, FSXXTX00410, FSXXTX00417, FSXXTX00196, FSXXTX00275, FSXXXX00051, FSXXTX00301, FSXXTX00262, FSXXTX00397, FSXXTX00285, FSXXTX00353, FSXXTX00363, FSXXTX00366, F9XXTX00046, F9XXTX00160, F9XXTX00176, FSXXTX00340, FSXXTX00346, F9XXTX00122, F9XXTX00068, FSXXTX00268, FSXXTX00041, FSXXTX00142, FSXXTX00386, 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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, F9XXTX00128, F9XXTX00129, F9XXTX00062, F9XXTX00067, F9XXTX00114, F9XXTX00162, F9XXTX00192, F9XXTX00133, F9XXTX00066, F9XXTX00115, F9XXTX00134, F9XXTX00164, F9XXTX00212, FSXXTX00140, F9XXTX00117, F9XXTX00227, FSXXTX00044, FSXXTX00040, F9XXTZ00001, F9XXTX00072, FSXXTX00026, F9XXXX00057, F9XXXX00058, F9XXXX00059, F9XXXX00004, F9XXTX00042, F9XXTX00005, F9XXTX00012, F9XXTX00013, F9XXXX00024, FSXXTX00226, FSXXTX00227, FSXXTX00250, FSXXTX00253, FSXXTX00254, FSXXXX00067, FSXXTX00228, FSXXTX00184, FSXXTX00287, FSXXTX00370, FSXXTX00379, FSXXXX00068, F9XXTX00006, FSXXTX00324, F9XXTX00233, F9XXTX00237, FSXXTX00313, FSXXTX00017, F9XXTX00165, F9XXTX00096, F9XXTX00234, FSXXTX00314, F9XXTX00077, F9XXTX00258, FSXXTX00110, F9XXTX00136, F9XXTX00141, F9XXTX00070, F9XXTX00214, FSXXTX00124, FSXXTX00188, F9XXTX00093, F9XXXX00054, F9XXTX00140, F9XXTX00186, F9XXTX00079, F9XXTX00223, F9XXTX00187, F9XXTX00086, F9XXXX00070, F9XXTX00225, F9XXTX00184, F9XXTX00206, F9XXTX00207, F9XXTX00256, F9XXTX00080, F9XXTX00103, 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	812
Z-2279-2023	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	16

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Look for serial numbers 3228PU4 or 6936PU9 on the system.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 49 states.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 3 months after the firm started it.

May 15, 2023Firm started the recall
Jul 31, 2023FDA classified it Class II
Aug 9, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/58267-ge-oec-oec-flexiv-9-inch-image-intensifier-may-detach">GE OEC OEC Flexiv: 9-inch Image Intensifier May Detach and Cause Injury (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2275-2023 (May 15, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2275-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.