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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92504

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 15, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
GE OEC Medical Systems, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

OEC Flexiview 8800 Systems with 9-inch Image Intensifier

Z-2275-2023
Recall number
Z-2275-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Serial Numbers: 3228PU4, 6936PU9

Distribution pattern

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.

device · product 2 of 5

OEC 9800 Systems with 9-inch Image Intensifier

Z-2276-2023
Recall number
Z-2276-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
58

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

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.

device · product 3 of 5

OEC 9900 Systems with 9-inch Image Intensifier

Z-2277-2023
Recall number
Z-2277-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
908

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

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.

device · product 4 of 5

OEC Elite Systems with 9-inch Image Intensifier

Z-2278-2023
Recall number
Z-2278-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
812

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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, FSXXTX00381, F9XXTX00243, FSXXTX00174, F9XXTX00242, FSXXTX00063, FSXXTX00064, FSXXTX00420, F9XXTX00031, FSXXTX00011, FSXXTX00164, FSXXTX00415, FSXXTX00416, FSXXTX00148, FSXXTX00375, F9XXTX00084, FSXXTX00046, FSXXTX00201, FSXXXX00065, F9XXXX00052, F9XXXX00053, FSXXXX00014, F9XXTX00138, FSXXTX00019, FSXXTX00084, FSXXTX00085, FSXXTX00269, FSXXTX00211, FSXXXX00029, FSXXTX00273, FSXXTX00372, FSXXTX00210, FSXXTX00092, FSXXTX00139, FSXXTX00243, F9XXTX00015, FSXXTX00238, FSXXTX00167, FSXXTX00157, FSXXTX00320, FSXXTX00394, F9XXTX00004, FSXXTX00005, FSXXTX00122, FSXXTX00237, FSXXTX00335, FSXXTX00137, FSXXTX00156, FSXXTX00215, FSXXTX00404, F9XXTX00217, F9XXTX00219, FSXXTX00113, FSXXTX00235, F9XXTX00027, F9XXTX00132, FSXXXX00034, FSXXTX00183, FSXXTX00043, FSXXTX00192, FSXXTX00336, F9XXTX00109, FSXXTX00299, F9XXTX00215, F9XXXX00033, F9XXXX00055, F9XXXX00056, FSXXTX00296, F9XXTX00099, F9XXTX00143, F9XXTX00144, F9XXTX00151, F9XXTX00161, 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, FSXXTX00284, FSXXTX00308, FSXXTX00202, FSXXTX00181, FSXXXX00047, 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, 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

Distribution pattern

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.

device · product 5 of 5

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

Z-2279-2023
Recall number
Z-2279-2023
Initiated
May 15, 2023
Classification
Class II
Status
Ongoing
Quantity
16

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

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.