Class 2 Device Recall DRX Revolution Mobile XRay System

• Date Initiated by Firm: October 02, 2023
• Date Posted: December 01, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0437-2024
• Recall Event ID: 93241
• 510(K)Number: K191025
• Product Classification: System, x-ray, mobile - Product Code IZL
• Product: DRX Revolution Mobile X-Ray System
• Code Information: Catalog No. 1019397, 1023423, 1030717, 1030725, 1044726, 1060177, 8608754, 1023415, 8610180, 8618894; UDI-DI (01)60889971019394(21)2185, (01)60889971019394(21)2186, (01)60889971019394(21)2187, (01)60889971019394(21)2193, (01)60889971019394(21)2194, (01)60889971019394(21)2195, (01)60889971019394(21)2196, (01)60889971019394(21)2200, (01)60889971019394(21)2203, (01)60889971019394(21)2204, (01)60889971019394(21)2205, (01)60889971019394(21)2206, (01)60889971019394(21)2207, (01)60889971019394(21)2208, (01)60889971019394(21)2209, (01)60889971019394(21)2210, (01)60889971019394(21)2213, (01)60889971019394(21)2217, (01)60889971019394(21)2218, (01)60889971019394(21)2221, (01)60889971019394(21)2227, (01)60889971019394(21)2232, (01)60889971019394(21)2233, (01)60889971019394(21)2235, (01)60889971019394(21)2236, (01)60889971019394(21)2237, (01)60889971019394(21)2240, (01)60889971019394(21)2243, (01)60889971019394(21)2247, (01)60889971019394(21)2248, (01)60889971019394(21)2249, (01)60889971019394(21)2250, (01)60889971019394(21)2251, (01)60889971019394(21)2252, (01)60889971019394(21)2253, (01)60889971019394(21)2259, (01)60889971019394(21)2264, (01)60889971019394(21)2265, (01)60889971019394(21)2266, (01)60889971019394(21)2267, (01)60889971019394(21)2270, (01)60889971019394(21)2271, (01)60889971019394(21)2272, (01)60889971019394(21)2273, (01)60889971019394(21)2274, (01)60889971019394(21)2275, (01)60889971019394(21)2276, (01)60889971019394(21)2277, (01)60889971019394(21)2278, (01)60889971019394(21)2279, (01)60889971019394(21)2280, (01)60889971019394(21)2281, (01)60889971019394(21)2282, (01)60889971019394(21)2283, (01)60889971019394(21)2284, (01)60889971019394(21)2285, (01)60889971019394(21)2286, (01)60889971019394(21)2287, (01)60889971019394(21)2289, (01)60889971019394(21)2290, (01)60889971019394(21)2291, (01)60889971019394(21)2292, (01)60889971019394(21)2293, (01)60889971019394(21)2294, (01)60889971019394(21)2295, (01)60889971019394(21)2299, (01)60889971019394(21)2300, (01)60889971019394(21)2302, (01)60889971019394(21)2303, (01)60889971019394(21)2305, (01)60889971019394(21)2306, (01)60889971019394(21)2307, (01)60889971019394(21)2308, (01)60889971019394(21)2309, (01)60889971019394(21)2310, (01)60889971019394(21)2311, (01)60889971019394(21)2312, (01)60889971019394(21)2314, (01)60889971019394(21)2316, (01)60889971019394(21)2317, (01)60889971019394(21)2318, (01)60889971019394(21)2319, (01)60889971019394(21)2320, (01)60889971019394(21)2321, (01)60889971019394(21)2322, (01)60889971019394(21)2323, (01)60889971019394(21)2324, (01)60889971019394(21)2325, (01)60889971019394(21)2326, (01)60889971019394(21)2327, (01)60889971019394(21)2335, (01)60889971019394(21)2355, (01)60889971019394(21)2356, (01)60889971019394(21)2357, (01)60889971019394(21)2358, (01)60889971019394(21)2359, (01)60889971019394(21)2367, (01)60889971019394(21)2368, (01)60889971019394(21)2369, (01)60889971019394(21)2370, (01)60889971019394(21)2371, (01)60889971019394(21)2372, (01)60889971019394(21)2373, (01)60889971019394(21)2374, (01)60889971019394(21)2375, (01)60889971019394(21)2376, (01)60889971019394(21)2378, (01)60889971019394(21)2379, (01)60889971019394(21)2380, (01)60889971019394(21)2381, (01)60889971019394(21)2382, (01)60889971019394(21)2383, (01)60889971019394(21)2388, (01)60889971019394(21)2389, (01)60889971019394(21)2392, (01)60889971019394(21)2394, (01)60889971019394(21)2395, (01)60889971019394(21)2396, (01)60889971019394(21)2397, (01)60889971019394(21)2398, (01)60889971019394(21)2399, (01)60889971019394(21)2400, (01)60889971019394(21)2401, (01)60889971019394(21)2402, (01)60889971019394(21)2403, (01)60889971019394(21)2404, (01)60889971019394(21)2405, (01)60889971019394(21)2406, (01)60889971019394(21)2408, (01)60889971019394(21)2409, (01)60889971019394(21)2410, (01)60889971019394(21)2411, (01)60889971019394(21)2412, (01)60889971019394(21)2413, (01)60889971019394(21)2414, (01)60889971019394(21)2415, (01)60889971019394(21)2416, (01)60889971019394(21)2417, (01)60889971019394(21)2418, (01)60889971019394(21)2419, (01)60889971019394(21)2420, (01)60889971019394(21)2422, (01)60889971019394(21)2428, (01)60889971019394(21)2429, (01)60889971019394(21)2430, (01)60889971019394(21)2431, (01)60889971019394(21)2443, (01)60889971019394(21)2444, (01)60889971019394(21)2449, (01)60889971019394(21)2450, (01)60889971019394(21)2452, (01)60889971019394(21)2453, (01)60889971019394(21)2454, (01)60889971019394(21)2456, (01)60889971019394(21)2457, (01)60889971019394(21)2460, (01)60889971019394(21)2461, (01)60889971019394(21)2462, (01)60889971019394(21)2463, (01)60889971019394(21)2464, (01)60889971019394(21)2465, (01)60889971019394(21)2466, (01)60889971019394(21)2467, (01)60889971019394(21)2468, (01)60889971019394(21)2469, (01)60889971019394(21)2470, (01)60889971019394(21)2471, (01)60889971019394(21)2472, (01)60889971019394(21)2473, (01)60889971019394(21)2474, (01)60889971019394(21)2476, (01)60889971019394(21)2477, (01)60889971019394(21)2478, (01)60889971019394(21)2482, (01)60889971019394(21)2483, (01)60889971019394(21)2484, (01)60889971019394(21)2485, (01)60889971019394(21)2486, (01)60889971019394(21)2487, (01)60889971019394(21)2488, (01)60889971019394(21)2489, (01)60889971019394(21)2490, (01)60889971019394(21)2491, (01)60889971019394(21)2492, (01)60889971019394(21)2496, (01)60889971019394(21)2497, (01)60889971019394(21)2498, (01)60889971019394(21)2499, (01)60889971019394(21)2500, (01)60889971019394(21)2501, (01)60889971019394(21)2502, (01)60889971019394(21)2503, (01)60889971019394(21)2504, (01)60889971019394(21)2505, (01)60889971019394(21)2506, (01)60889971019394(21)2507, (01)60889971019394(21)2508, (01)60889971019394(21)2509, (01)60889971019394(21)2510, (01)60889971019394(21)2511, (01)60889971019394(21)2512, (01)60889971019394(21)2513, (01)60889971019394(21)2514, (01)60889971019394(21)2515, (01)60889971019394(21)2516, (01)60889971019394(21)2518, (01)60889971019394(21)2519, (01)60889971019394(21)2521, (01)60889971019394(21)2522, (01)60889971019394(21)2523, (01)60889971019394(21)2524, (01)60889971019394(21)2525, (01)60889971019394(21)2526, (01)60889971019394(21)2527, (01)60889971019394(21)2528, (01)60889971019394(21)2529, (01)60889971019394(21)2530, (01)60889971019394(21)2531, (01)60889971019394(21)2532, (01)60889971019394(21)2533, (01)60889971019394(21)2534, (01)60889971019394(21)2535, (01)60889971019394(21)2536, (01)60889971019394(21)2539, (01)60889971019394(21)2540, (01)60889971019394(21)2541, (01)60889971019394(21)2542, (01)60889971019394(21)2543, (01)60889971019394(21)2544, (01)60889971019394(21)2545, (01)60889971019394(21)2546, (01)60889971019394(21)2547, (01)60889971019394(21)2550, (01)60889971019394(21)2551, (01)60889971019394(21)2552, (01)60889971019394(21)2553, (01)60889971019394(21)2559, (01)60889971019394(21)2560, (01)60889971019394(21)2561, (01)60889971019394(21)2566, (01)60889971019394(21)2567, (01)60889971019394(21)2570, (01)60889971019394(21)2572, (01)60889971019394(21)2573, (01)60889971019394(21)2574, (01)60889971019394(21)2575, (01)60889971019394(21)2576, (01)60889971019394(21)2577, (01)60889971019394(21)2578, (01)60889971019394(21)2579, (01)60889971019394(21)2580, (01)60889971019394(21)2581, (01)60889971019394(21)2582, (01)60889971019394(21)2584, (01)60889971019394(21)2585, (01)60889971019394(21)2586, (01)60889971019394(21)2587, (01)60889971019394(21)2588, (01)60889971019394(21)2592, (01)60889971019394(21)2593, (01)60889971019394(21)2594, (01)60889971019394(21)2595, (01)60889971019394(21)2596, (01)60889971019394(21)2597, (01)60889971019394(21)2598, (01)60889971019394(21)2599, (01)60889971019394(21)2600, (01)60889971019394(21)2601, (01)60889971019394(21)2602, (01)60889971019394(21)2604, (01)60889971019394(21)2605, (01)60889971019394(21)2606, (01)60889971019394(21)2607, (01)60889971019394(21)2608, (01)60889971019394(21)2612, (01)60889971019394(21)2623, (01)60889971019394(21)2624, (01)60889971019394(21)2625, (01)60889971019394(21)2626, (01)60889971019394(21)2627, (01)60889971019394(21)2628, (01)60889971019394(21)2629, (01)60889971019394(21)2631, (01)60889971019394(21)2632, (01)60889971019394(21)2634, (01)60889971019394(21)2635, (01)60889971019394(21)2647, (01)60889971019394(21)2648, (01)60889971019394(21)2649, (01)60889971019394(21)2670, (01)60889971019394(21)2671, (01)60889971019394(21)2672, (01)60889971019394(21)2673, (01)60889971019394(21)2676, (01)60889971019394(21)2677, (01)60889971019394(21)2678, (01)60889971019394(21)2680, (01)60889971019394(21)2682, (01)60889971019394(21)2683, (01)60889971019394(21)2684, (01)60889971019394(21)2685, (01)60889971019394(21)2686, (01)60889971019394(21)2691, (01)60889971019394(21)2692, (01)60889971019394(21)2693, (01)60889971019394(21)2695, (01)60889971019394(21)2696, (01)60889971019394(21)2697, (01)60889971019394(21)2698, (01)60889971019394(21)2699, (01)60889971019394(21)2700, (01)60889971019394(21)2701, (01)60889971019394(21)2702, (01)60889971019394(21)2703, (01)60889971019394(21)2705, (01)60889971019394(21)2706, (01)60889971019394(21)2707, (01)60889971019394(21)2708, (01)60889971019394(21)2709, (01)60889971019394(21)2710, (01)60889971019394(21)2714, (01)60889971019394(21)2715, (01)60889971019394(21)2717, (01)60889971019394(21)2718, (01)60889971019394(21)2719, (01)60889971019394(21)2720, (01)60889971019394(21)2721, (01)60889971019394(21)2722, (01)60889971019394(21)2723, (01)60889971019394(21)2724, (01)60889971019394(21)2725, (01)60889971019394(21)2727, (01)60889971019394(21)2728, (01)60889971019394(21)2729, (01)60889971019394(21)2733, (01)60889971019394(21)2734, (01)60889971019394(21)2735, (01)60889971019394(21)2738, (01)60889971019394(21)2740, (01)60889971019394(21)2742, (01)60889971019394(21)2743, (01)60889971019394(21)2744, (01)60889971019394(21)2745, (01)60889971019394(21)2747, (01)60889971019394(21)2749, (01)60889971019394(21)2753, (01)60889971019394(21)2754, (01)60889971019394(21)2755, (01)60889971019394(21)2756, (01)60889971019394(21)2757, (01)60889971019394(21)2760, (01)60889971019394(21)2761, (01)60889971019394(21)2762, (01)60889971019394(21)2763, (01)60889971019394(21)2765, (01)60889971019394(21)2768, (01)60889971019394(21)2771, (01)60889971019394(21)2773, (01)60889971019394(21)2774, (01)60889971019394(21)2776, (01)60889971019394(21)2777, (01)60889971019394(21)2778, (01)60889971019394(21)2779, (01)60889971019394(21)2780, (01)60889971019394(21)2781, (01)60889971019394(21)2782, (01)60889971019394(21)2783, (01)60889971019394(21)2785, (01)60889971019394(21)2791, (01)60889971019394(21)2792, (01)60889971019394(21)2797, (01)60889971019394(21)2799, (01)60889971019394(21)2800, (01)60889971019394(21)2802, (01)60889971019394(21)2803, (01)60889971019394(21)2804, (01)60889971019394(21)2805, (01)60889971019394(21)2806, (01)60889971019394(21)2807, (01)60889971019394(21)2808, (01)60889971019394(21)2813, (01)60889971019394(21)2814, (01)60889971019394(21)2815, (01)60889971019394(21)2816, (01)60889971019394(21)2817, (01)60889971019394(21)2821, (01)60889971019394(21)2822, (01)60889971019394(21)2827, (01)60889971019394(21)2828, (01)60889971019394(21)2829, (01)60889971019394(21)2834, (01)60889971019394(21)2836, (01)60889971019394(21)2837, (01)60889971019394(21)2838, (01)60889971019394(21)2839, (01)60889971019394(21)2840, (01)60889971019394(21)2841, (01)60889971019394(21)2842, (01)60889971019394(21)2844, (01)60889971019394(21)2845, (01)60889971019394(21)2846, (01)60889971019394(21)2847, (01)60889971019394(21)2848, (01)60889971019394(21)2849, (01)60889971019394(21)2850, (01)60889971019394(21)2851, (01)60889971019394(21)2852, (01)60889971019394(21)2853, (01)60889971019394(21)2854, (01)60889971019394(21)2855, (01)60889971019394(21)2856, (01)60889971019394(21)2857, (01)60889971019394(21)2858, (01)60889971019394(21)2859, (01)60889971019394(21)2860, (01)60889971019394(21)2861, (01)60889971019394(21)2862, (01)60889971019394(21)2865, (01)60889971019394(21)2866, (01)60889971019394(21)2867, (01)60889971019394(21)2868, (01)60889971019394(21)2869, (01)60889971019394(21)2870, (01)60889971019394(21)2872, (01)60889971019394(21)2873, (01)60889971019394(21)2874, (01)60889971019394(21)2875, (01)60889971019394(21)2878, (01)60889971019394(21)2879, (01)60889971019394(21)2880, (01)60889971019394(21)2881, (01)60889971019394(21)2882, (01)60889971019394(21)2883, (01)60889971019394(21)2884, (01)60889971019394(21)2886, (01)60889971019394(21)2888, (01)60889971019394(21)2889, (01)60889971019394(21)2890, (01)60889971019394(21)2893, (01)60889971019394(21)2894, (01)60889971019394(21)2895, (01)60889971019394(21)2896, (01)60889971019394(21)2897, (01)60889971019394(21)2898, (01)60889971019394(21)2899, (01)60889971019394(21)2905, (01)60889971019394(21)2908, (01)60889971019394(21)2911, (01)60889971019394(21)2912, (01)60889971019394(21)2916, (01)60889971019394(21)2918, (01)60889971019394(21)2919, (01)60889971019394(21)2920, (01)60889971019394(21)2921, (01)60889971019394(21)2925, (01)60889971019394(21)2926, (01)60889971019394(21)2927, (01)60889971019394(21)2929, (01)60889971019394(21)2930, (01)60889971019394(21)2931, (01)60889971019394(21)2932, (01)60889971019394(21)2933, (01)60889971019394(21)2935, (01)60889971019394(21)2937, (01)60889971019394(21)2938, (01)60889971019394(21)2939, (01)60889971019394(21)2940, (01)60889971019394(21)2941, (01)60889971019394(21)2944, (01)60889971019394(21)2945, (01)60889971019394(21)2946, (01)60889971019394(21)2949, (01)60889971019394(21)2950, (01)60889971019394(21)2951, (01)60889971019394(21)2952, (01)60889971019394(21)2963, (01)60889971019394(21)2966, (01)60889971019394(21)2967, (01)60889971019394(21)2968, (01)60889971019394(21)2969, (01)60889971019394(21)2973, (01)60889971019394(21)2974, (01)60889971019394(21)2975, (01)60889971019394(21)2977, (01)60889971019394(21)2978, (01)60889971019394(21)2979, (01)60889971019394(21)2980, (01)60889971019394(21)2981, (01)60889971019394(21)2982, (01)60889971019394(21)2983, (01)60889971019394(21)2984, (01)60889971019394(21)2986, (01)60889971019394(21)2987, (01)60889971019394(21)2988, (01)60889971019394(21)2989, (01)60889971019394(21)2990, (01)60889971019394(21)2991, (01)60889971019394(21)2992, (01)60889971019394(21)2993, (01)60889971019394(21)2994, (01)60889971019394(21)2995, (01)60889971019394(21)2996, (01)60889971019394(21)2997, (01)60889971019394(21)3000, (01)60889971019394(21)3002, (01)60889971019394(21)3003, (01)60889971019394(21)3004, (01)60889971019394(21)3005, (01)60889971019394(21)3006, (01)60889971019394(21)3007, (01)60889971019394(21)3008, (01)60889971019394(21)3009, (01)60889971019394(21)3010, (01)60889971019394(21)3011, (01)60889971019394(21)3020, (01)60889971019394(21)3021, (01)60889971019394(21)3025, (01)60889971019394(21)3030, (01)60889971019394(21)3031, (01)60889971019394(21)3032, (01)60889971019394(21)3033, (01)60889971019394(21)3034, (01)60889971019394(21)3036, (01)60889971019394(21)3037, (01)60889971019394(21)3038, (01)60889971019394(21)3040, (01)60889971019394(21)3041, (01)60889971019394(21)3042, (01)60889971019394(21)3043, (01)60889971019394(21)3044, (01)60889971019394(21)3045, (01)60889971019394(21)3049, (01)60889971019394(21)3050, (01)60889971019394(21)3052, (01)60889971019394(21)3053, (01)60889971019394(21)3054, (01)60889971019394(21)3055, (01)60889971019394(21)3056, (01)60889971019394(21)3057, (01)60889971019394(21)3058, (01)60889971019394(21)3059, (01)60889971019394(21)3063, (01)60889971019394(21)3064, (01)60889971019394(21)3065, (01)60889971019394(21)3066, (01)60889971019394(21)3067, (01)60889971019394(21)3068, (01)60889971019394(21)3070, (01)60889971019394(21)3071, (01)60889971019394(21)3074, (01)60889971019394(21)3075, (01)60889971019394(21)3076, (01)60889971019394(21)3077, (01)60889971019394(21)3078, (01)60889971019394(21)3079, (01)60889971019394(21)3080, (01)60889971019394(21)3081, (01)60889971019394(21)3082, (01)60889971019394(21)3083, (01)60889971019394(21)3084, (01)60889971019394(21)3085, (01)60889971019394(21)3086, (01)60889971019394(21)3087, (01)60889971019394(21)3088, (01)60889971019394(21)3089, (01)60889971019394(21)3092, (01)60889971019394(21)3093, (01)60889971019394(21)3095, (01)60889971019394(21)3096, (01)60889971019394(21)3097, (01)60889971019394(21)3098, (01)60889971019394(21)3099, (01)60889971019394(21)3100, (01)60889971019394(21)3102, (01)60889971019394(21)3103, (01)60889971019394(21)3106, (01)60889971019394(21)3107, (01)60889971019394(21)3108, (01)60889971019394(21)3109, (01)60889971019394(21)3110, (01)60889971019394(21)3111, (01)60889971019394(21)3112, (01)60889971019394(21)3113, (01)60889971019394(21)3114, (01)60889971019394(21)3119, (01)60889971019394(21)3130, (01)60889971019394(21)3132, (01)60889971019394(21)3133, (01)60889971019394(21)3135, (01)60889971019394(21)3136, (01)60889971019394(21)3137, (01)60889971019394(21)3138, (01)60889971019394(21)3139, (01)60889971019394(21)3140, (01)60889971019394(21)3141, (01)60889971019394(21)3142, (01)60889971019394(21)3144, (01)60889971019394(21)3145, (01)60889971019394(21)3147, (01)60889971019394(21)3148, (01)60889971019394(21)3149, (01)60889971019394(21)3150, (01)60889971019394(21)3151, (01)60889971019394(21)3152, (01)60889971019394(21)3153, (01)60889971019394(21)3154, (01)60889971019394(21)3155, (01)60889971019394(21)3156, (01)60889971019394(21)3158, (01)60889971019394(21)3159, (01)60889971019394(21)3160, (01)60889971019394(21)3161, (01)60889971019394(21)3162, (01)60889971019394(21)3163, (01)60889971019394(21)3164, (01)60889971019394(21)3165, (01)60889971019394(21)3166, (01)60889971019394(21)3167, (01)60889971019394(21)3168, (01)60889971019394(21)3169, (01)60889971019394(21)3171, (01)60889971019394(21)3172, (01)60889971019394(21)3174, (01)60889971019394(21)3181, (01)60889971019394(21)3182, (01)60889971019394(21)3184, (01)60889971019394(21)3185, (01)60889971019394(21)3188, (01)60889971019394(21)3189, (01)60889971019394(21)3190, (01)60889971019394(21)3191, (01)60889971019394(21)3192, (01)60889971019394(21)3193, (01)60889971019394(21)3194, (01)60889971019394(21)3196, (01)60889971019394(21)3197, (01)60889971019394(21)3198, (01)60889971019394(21)3199, (01)60889971019394(21)3200, (01)60889971019394(21)3201, (01)60889971019394(21)3202, (01)60889971019394(21)3203, (01)60889971019394(21)3205, (01)60889971019394(21)3206, (01)60889971019394(21)3207, (01)60889971019394(21)3209, (01)60889971019394(21)3210, (01)60889971019394(21)3211, (01)60889971019394(21)3212, (01)60889971019394(21)3213, (01)60889971019394(21)3214, (01)60889971019394(21)3215, (01)60889971019394(21)3216, (01)60889971019394(21)3217, (01)60889971019394(21)3218, (01)60889971019394(21)3219, (01)60889971019394(21)3220, (01)60889971019394(21)3221, (01)60889971019394(21)3222, (01)60889971019394(21)3223, (01)60889971019394(21)3224, (01)60889971019394(21)3225, (01)60889971019394(21)3226, (01)60889971019394(21)3227, (01)60889971019394(21)3230, (01)60889971019394(21)3329, (01)60889971019394(21)3332, (01)60889971019394(21)3336, (01)60889971019394(21)3337, (01)60889971019394(21)3338, (01)60889971019394(21)3339, (01)60889971019394(21)3342, (01)60889971019394(21)3343, (01)60889971019394(21)3344, (01)60889971019394(21)3345, (01)60889971019394(21)3346, (01)60889971019394(21)3347, (01)60889971019394(21)3349, (01)60889971019394(21)3350, (01)60889971019394(21)3355, (01)60889971019394(21)3356, (01)60889971019394(21)3357, (01)60889971019394(21)3359, (01)60889971019394(21)3360, (01)60889971019394(21)3364, (01)60889971019394(21)3365, (01)60889971019394(21)3366, (01)60889971019394(21)3368, (01)60889971019394(21)3369, (01)60889971019394(21)3370, (01)60889971019394(21)3371, (01)60889971019394(21)3372, (01)60889971019394(21)3378, (01)60889971019394(21)3383, (01)60889971019394(21)3384, (01)60889971019394(21)3385, (01)60889971019394(21)3386, (01)60889971019394(21)3387, (01)60889971019394(21)3390, (01)60889971019394(21)3393, (01)60889971019394(21)3396, (01)60889971019394(21)3397, (01)60889971019394(21)3398, (01)60889971019394(21)3399, (01)60889971019394(21)3400, (01)60889971019394(21)3401, (01)60889971019394(21)3403, (01)60889971019394(21)3408, (01)60889971019394(21)3409, (01)60889971019394(21)3410, (01)60889971019394(21)3417, (01)60889971019394(21)3418, (01)60889971019394(21)3419, (01)60889971019394(21)3423, (01)60889971019394(21)3424, (01)60889971019394(21)3427, (01)60889971019394(21)3428, (01)60889971019394(21)3429, (01)60889971019394(21)3432, (01)60889971019394(21)3434, (01)60889971019394(21)3435, (01)60889971019394(21)3437, (01)60889971019394(21)3438, (01)60889971019394(21)3439, (01)60889971019394(21)3440, (01)60889971019394(21)3441, (01)60889971019394(21)3442, (01)60889971019394(21)3443, (01)60889971019394(21)3444, (01)60889971019394(21)3445, (01)60889971019394(21)3446, (01)60889971019394(21)3447, (01)60889971019394(21)3448, (01)60889971019394(21)3449, (01)60889971019394(21)3450, (01)60889971019394(21)3451, (01)60889971019394(21)3452, (01)60889971019394(21)3453, (01)60889971019394(21)3454, (01)60889971019394(21)3455, (01)60889971019394(21)3456, (01)60889971019394(21)3457, (01)60889971019394(21)3458, (01)60889971019394(21)3461, (01)60889971019394(21)3462, (01)60889971019394(21)3507, (01)60889971019394(21)3508, (01)60889971019394(21)3520, (01)60889971019394(21)3540, (01)60889971019394(21)3541, (01)60889971019394(21)3542, (01)60889971019394(21)3609, (01)60889971019394(21)4731, (01)60889971019394(21)4732, (01)60889971019394(21)4733, (01)60889971019394(21)4734, ;Serial No. 101, 111, 114, 119, 121, 122, 123, 124, 125, 126, 134, 151, 152, 153, 154, 155, 161, 162, 164, 165, 166, 167, 168, 169, 173, 174, 176, 177, 178, 180, 182, 183, 188, 190, 191, 192, 196, 198, 199, 200, 201, 202, 203, 205, 206, 207, 208, 211, 222, 223, 224, 225, 226, 227, 228, 230, 231, 235, 236, 237, 238, 239, 240, 241, 242, 243, 245, 246, 247, 248, 249, 254, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 275, 276, 279, 280, 281, 282, 283, 284, 285, 286, 305, 312, 316, 317, 318, 319, 320, 321, 322, 323, 324, 325, 326, 330, 332, 333, 334, 339, 340, 341, 342, 343, 344, 345, 346, 347, 348, 349, 353, 355, 357, 358, 359, 360, 361, 362, 364, 365, 375, 376, 379, 380, 381, 382, 383, 384, 385, 386, 387, 388, 394, 395, 396, 397, 398, 399, 400, 401, 403, 404, 405, 411, 412, 413, 414, 415, 417, 420, 421, 423, 431, 432, 433, 434, 435, 441, 442, 443, 444, 451, 455, 456, 457, 458, 459, 460, 461, 464, 466, 467, 487, 488, 489, 490, 495, 498, 506, 510, 511, 512, 514, 515, 516, 517, 518, 519, 522, 524, 530, 538, 540, 541, 542, 543, 544, 545, 546, 547, 548, 549, 555, 557, 560, 561, 562, 563, 564, 581, 583, 584, 590, 591, 592, 593, 594, 595, 596, 597, 598, 599, 600, 601, 602, 603, 609, 610, 612, 613, 616, 619, 620, 621, 626, 627, 628, 629, 631, 632, 633, 634, 635, 636, 637, 639, 644, 645, 649, 650, 651, 657, 658, 659, 660, 662, 663, 664, 665, 676, 677, 678, 679, 680, 681, 682, 685, 686, 687, 688, 689, 690, 691, 692, 693, 694, 695, 696, 697, 699, 700, 701, 702, 703, 704, 705, 706, 707, 708, 709, 710, 711, 712, 713, 714, 715, 718, 721, 723, 724, 725, 727, 728, 729, 730, 731, 732, 733, 734, 735, 736, 740, 741, 745, 746, 747, 748, 749, 750, 751, 752, 753, 754, 760, 761, 762, 764, 765, 766, 767, 768, 773, 774, 777, 790, 791, 792, 796, 797, 798, 801, 802, 803, 806, 807, 808, 809, 810, 815, 816, 819, 821, 822, 823, 826, 827, 833, 834, 840, 841, 842, 844, 849, 850, 851, 852, 854, 863, 864, 865, 867, 868, 869, 870, 871, 872, 873, 874, 875, 876, 878, 879, 880, 890, 894, 895, 896, 897, 899, 900, 901, 903, 904, 905, 907, 913, 914, 915, 919, 920, 921, 922, 927, 928, 930, 931, 932, 935, 939, 940, 941, 942, 943, 944, 945, 956, 957, 958, 959, 961, 962, 963, 966, 967, 969, 975, 976, 977, 978, 979, 980, 982, 983, 984, 985, 986, 988, 990, 991, 992, 993, 994, 995, 996, 997, 998, 999, 1000, 1002, 1009, 1027, 1030, 1033, 1035, 1036, 1037, 1038, 1039, 1040, 1041, 1042, 1043, 1044, 1045, 1046, 1047, 1048, 1049, 1050, 1051, 1054, 1057, 1058, 1059, 1060, 1064, 1065, 1066, 1067, 1068, 1069, 1074, 1081, 1083, 1085, 1096, 1097, 1098, 1100, 1101, 1102, 1104, 1106, 1107, 1108, 1109, 1110, 1111, 1112, 1118, 1119, 1124, 1125, 1126, 1127, 1128, 1129, 1130, 1131, 1132, 1133, 1134, 1135, 1136, 1137, 1139, 1140, 1141, 1142, 1143, 1144, 1145, 1146, 1147, 1148, 1149, 1150, 1151, 1152, 1153, 1154, 1159, 1160, 1161, 1162, 1163, 1164, 1168, 1171, 1172, 1173, 1175, 1176, 1177, 1178, 1179, 1180, 1182, 1183, 1184, 1185, 1186, 1195, 1196, 1198, 1201, 1202, 1203, 1204, 1205, 1206, 1207, 1208, 1210, 1211, 1222, 1223, 1224, 1225, 1226, 1227, 1228, 1229, 1230, 1231, 1232, 1233, 1234, 1235, 1236, 1237, 1238, 1239, 1240, 1241, 1245, 1246, 1254, 1255, 1256, 1257, 1258, 1259, 1260, 1261, 1264, 1265, 1266, 1280, 1285, 1286, 1290, 1291, 1292, 1293, 1294, 1295, 1296, 1297, 1298, 1300, 1301, 1302, 1303, 1304, 1305, 1306, 1308, 1309, 1315, 1316, 1334, 1335, 1336, 1337, 1338, 1339, 1340, 1341, 1343, 1345, 1348, 1349, 1356, 1357, 1358, 1359, 1360, 1361, 1362, 1363, 1364, 1378, 1379, 1380, 1386, 1388, 1389, 1390, 1391, 1394, 1395, 1396, 1401, 1403, 1404, 1405, 1406, 1407, 1408, 1409, 1415, 1416, 1417, 1418, 1419, 1420, 1421, 1422, 1427, 1428, 1429, 1430, 1436, 1437, 1439, 1458, 1459, 1460, 1461, 1462, 1463, 1466, 1467, 1468, 1469, 1470, 1473, 1474, 1475, 1476, 1477, 1478, 1479, 1480, 1482, 1483, 1484, 1485, 1486, 1487, 1488, 1490, 1491, 1494, 1495, 1496, 1497, 1498, 1499, 1500, 1503, 1504, 1505, 1506, 1507, 1510, 1511, 1512, 1514, 1524, 1529, 1530, 1537, 1538, 1539, 1540, 1542, 1544, 1545, 1546, 1549, 1550, 1551, 1552, 1553, 1555, 1556, 1557, 1558, 1559, 1561, 1568, 1569, 1570, 1571, 1573, 1574, 1575, 1591, 1592, 1593, 1595, 1596, 1597, 1604, 1605, 1606, 1607, 1608, 1610, 1611, 1612, 1613, 1614, 1615, 1616, 1617, 1618, 1619, 1620, 1621, 1622, 1623, 1624, 1625, 1637, 1638, 1642, 1643, 1644, 1645, 1646, 1647, 1649, 1650, 1652, 1653, 1656, 1657, 1660, 1661, 1662, 1663, 1664, 1665, 1666, 1667, 1668, 1669, 1674, 1675, 1677, 1678, 1679, 1680, 1681, 1682, 1683, 1686, 1687, 1688, 1689, 1694, 1697, 1701, 1702, 1703, 1704, 1705, 1706, 1709, 1710, 1711, 1712, 1713, 1714, 1715, 1716, 1721, 1723, 1724, 1725, 1726, 1727, 1732, 1733, 1734, 1735, 1738, 1742, 1743, 1746, 1747, 1748, 1749, 1750, 1751, 1752, 1753, 1754, 1756, 1757, 1758, 1759, 1760, 1761, 1773, 1774, 1775, 1776, 1777, 1778, 1779, 1780, 1781, 1782, 1784, 1785, 1788, 1789, 1802, 1803, 1804, 1806, 1807, 1808, 1811, 1812, 1815, 1816, 1833, 1837, 1838, 1839, 1841, 1842, 1843, 1844, 1845, 1846, 1847, 1848, 1849, 1850, 1851, 1854, 1855, 1856, 1857, 1858, 1859, 1860, 1861, 1862, 1863, 1864, 1866, 1873, 1874, 1875, 1876, 1877, 1881, 1882, 1883, 1884, 1885, 1886, 1889, 1891, 1896, 1897, 1898, 1899, 1900, 1901, 1902, 1903, 1904, 1905, 1906, 1907, 1908, 1909, 1912, 1915, 1916, 1917, 1918, 1919, 1920, 1921, 1922, 1926, 1927, 1928, 1929, 1933, 1934, 1935, 1936, 1937, 1938, 1939, 1940, 1941, 1943, 1945, 1946, 1947, 1949, 1950, 1954, 1956, 1957, 1959, 1960, 1964, 1966, 1968, 1969, 1970, 1971, 1981, 1982, 1983, 1984, 1985, 1986, 1988, 1989, 1990, 1996, 1998, 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2011, 2012, 2014, 2015, 2016, 2017, 2020, 2021, 2022, 2024, 2026, 2027, 2028, 2043, 2044, 2045, 2046, 2048, 2051, 2052, 2058, 2059, 2060, 2061, 2062, 2063, 2072, 2073, 2075, 2076, 2077, 2078, 2079, 2081, 2082, 2083, 2084, 2085, 2086, 2087, 2089, 2090, 2091, 2093, 2094, 2097, 2098, 2102, 2103, 2104, 2105, 2106, 2107, 2108, 2110, 2111, 2113, 2114, 2115, 2118, 2119, 2120, 2121, 2122, 2123, 2124, 2125, 2126, 2127, 2129, 2132, 2133, 2134, 2136, 2137, 2138, 2143, 2144, 2145, 2149, 2150, 2151, 2152, 2153, 2154, 2155, 2156, 2157, 2158, 2159, 2160, 2162, 2163, 2164, 2165, 2168, 2169, 2173, 2174, 2175, 2176, 2177, 2178, 2179, 2180, 2181, 2182, 2183, 2185, 2186, 2187, 2193, 2194, 2195, 2196, 2200, 2203, 2204, 2205, 2206, 2207, 2208, 2209, 2210, 2213, 2217, 2218, 2221, 2227, 2232, 2233, 2235, 2236, 2237, 2240, 2243, 2247, 2248, 2249, 2250, 2251, 2252, 2253, 2259, 2264, 2265, 2266, 2267, 2270, 2271, 2272, 2273, 2274, 2275, 2276, 2277, 2278, 2279, 2280, 2281, 2282, 2283, 2284, 2285, 2286, 2287, 2289, 2290, 2291, 2292, 2293, 2294, 2295, 2299, 2300, 2302, 2303, 2305, 2306, 2307, 2308, 2309, 2310, 2311, 2312, 2314, 2316, 2317, 2318, 2319, 2320, 2321, 2322, 2323, 2324, 2325, 2326, 2327, 2335, 2355, 2356, 2357, 2358, 2359, 2367, 2368, 2369, 2370, 2371, 2372, 2373, 2374, 2375, 2376, 2378, 2379, 2380, 2381, 2382, 2383, 2388, 2389, 2392, 2394, 2395, 2396, 2397, 2398, 2399, 2400, 2401, 2402, 2403, 2404, 2405, 2406, 2408, 2409, 2410, 2411, 2412, 2413, 2414, 2415, 2416, 2417, 2418, 2419, 2420, 2422, 2428, 2429, 2430, 2431, 2443, 2444, 2449, 2450, 2452, 2453, 2454, 2456, 2457, 2460, 2461, 2462, 2463, 2464, 2465, 2466, 2467, 2468, 2469, 2470, 2471, 2472, 2473, 2474, 2476, 2477, 2478, 2482, 2483, 2484, 2485, 2486, 2487, 2488, 2489, 2490, 2491, 2492, 2496, 2497, 2498, 2499, 2500, 2501, 2502, 2503, 2504, 2505, 2506, 2507, 2508, 2509, 2510, 2511, 2512, 2513, 2514, 2515, 2516, 2518, 2519, 2521, 2522, 2523, 2524, 2525, 2526, 2527, 2528, 2529, 2530, 2531, 2532, 2533, 2534, 2535, 2536, 2539, 2540, 2541, 2542, 2543, 2544, 2545, 2546, 2547, 2550, 2551, 2552, 2553, 2559, 2560, 2561, 2566, 2567, 2570, 2572, 2573, 2574, 2575, 2576, 2577, 2578, 2579, 2580, 2581, 2582, 2584, 2585, 2586, 2587, 2588, 2592, 2593, 2594, 2595, 2596, 2597, 2598, 2599, 2600, 2601, 2602, 2604, 2605, 2606, 2607, 2608, 2612, 2623, 2624, 2625, 2626, 2627, 2628, 2629, 2631, 2632, 2634, 2635, 2647, 2648, 2649, 2670, 2671, 2672, 2673, 2676, 2677, 2678, 2680, 2682, 2683, 2684, 2685, 2686, 2691, 2692, 2693, 2695, 2696, 2697, 2698, 2699, 2700, 2701, 2702, 2703, 2705, 2706, 2707, 2708, 2709, 2710, 2714, 2715, 2717, 2718, 2719, 2720, 2721, 2722, 2723, 2724, 2725, 2727, 2728, 2729, 2733, 2734, 2735, 2738, 2740, 2742, 2743, 2744, 2745, 2747, 2749, 2753, 2754, 2755, 2756, 2757, 2760, 2761, 2762, 2763, 2765, 2768, 2771, 2773, 2774, 2776, 2777, 2778, 2779, 2780, 2781, 2782, 2783, 2785, 2791, 2792, 2797, 2799, 2800, 2802, 2803, 2804, 2805, 2806, 2807, 2808, 2813, 2814, 2815, 2816, 2817, 2821, 2822, 2827, 2828, 2829, 2834, 2836, 2837, 2838, 2839, 2840, 2841, 2842, 2844, 2845, 2846, 2847, 2848, 2849, 2850, 2851, 2852, 2853, 2854, 2855, 2856, 2857, 2858, 2859, 2860, 2861, 2862, 2865, 2866, 2867, 2868, 2869, 2870, 2872, 2873, 2874, 2875, 2878, 2879, 2880, 2881, 2882, 2883, 2884, 2886, 2888, 2889, 2890, 2893, 2894, 2895, 2896, 2897, 2898, 2899, 2905, 2908, 2911, 2912, 2916, 2918, 2919, 2920, 2921, 2925, 2926, 2927, 2929, 2930, 2931, 2932, 2933, 2935, 2937, 2938, 2939, 2940, 2941, 2944, 2945, 2946, 2949, 2950, 2951, 2952, 2963, 2966, 2967, 2968, 2969, 2973, 2974, 2975, 2977, 2978, 2979, 2980, 2981, 2982, 2983, 2984, 2986, 2987, 2988, 2989, 2990, 2991, 2992, 2993, 2994, 2995, 2996, 2997, 3000, 3002, 3003, 3004, 3005, 3006, 3007, 3008, 3009, 3010, 3011, 3020, 3021, 3025, 3030, 3031, 3032, 3033, 3034, 3036, 3037, 3038, 3040, 3041, 3042, 3043, 3044, 3045, 3049, 3050, 3052, 3053, 3054, 3055, 3056, 3057, 3058, 3059, 3063, 3064, 3065, 3066, 3067, 3068, 3070, 3071, 3074, 3075, 3076, 3077, 3078, 3079, 3080, 3081, 3082, 3083, 3084, 3085, 3086, 3087, 3088, 3089, 3092, 3093, 3095, 3096, 3097, 3098, 3099, 3100, 3102, 3103, 3106, 3107, 3108, 3109, 3110, 3111, 3112, 3113, 3114, 3119, 3130, 3132, 3133, 3135, 3136, 3137, 3138, 3139, 3140, 3141, 3142, 3144, 3145, 3147, 3148, 3149, 3150, 3151, 3152, 3153, 3154, 3155, 3156, 3158, 3159, 3160, 3161, 3162, 3163, 3164, 3165, 3166, 3167, 3168, 3169, 3171, 3172, 3174, 3181, 3182, 3184, 3185, 3188, 3189, 3190, 3191, 3192, 3193, 3194, 3196, 3197, 3198, 3199, 3200, 3201, 3202, 3203, 3205, 3206, 3207, 3209, 3210, 3211, 3212, 3213, 3214, 3215, 3216, 3217, 3218, 3219, 3220, 3221, 3222, 3223, 3224, 3225, 3226, 3227, 3230, 3329, 3332, 3336, 3337, 3338, 3339, 3342, 3343, 3344, 3345, 3346, 3347, 3349, 3350, 3355, 3356, 3357, 3359, 3360, 3364, 3365, 3366, 3368, 3369, 3370, 3371, 3372, 3378, 3383, 3384, 3385, 3386, 3387, 3390, 3393, 3396, 3397, 3398, 3399, 3400, 3401, 3403, 3408, 3409, 3410, 3417, 3418, 3419, 3423, 3424, 3427, 3428, 3429, 3432, 3434, 3435, 3437, 3438, 3439, 3440, 3441, 3442, 3443, 3444, 3445, 3446, 3447, 3448, 3449, 3450, 3451, 3452, 3453, 3454, 3455, 3456, 3457, 3458, 3461, 3462, 3507, 3508, 3520, 3540, 3541, 3542, 3609, 4731, 4732, 4733, 4734.
• Recalling Firm/ Manufacturer: Carestream Health, Inc.; 1049 W Ridge Rd; Rochester NY 14615-2731
• For Additional Information Contact: Customer Care Center; 1-800-328-2910
• Manufacturer Reason for Recall: Unexpected failure of electrical components within the CPI generator.
• FDA Determined Cause: Component design/selection
• Action: Consignees were sent a "MEDICAL DEVICE FIELD CORRECTIVE ACTION" on 10/02/2023. This notice requested that consignees inform all personnel that utilize the affected devices of the recall notice and to return the provided Consignee Notification Acknowledgement form completed. If a failure similar to the one associated with this recall event were to occur, users should move the system away from patients and staff, the system should be identified as inoperable, and a call should be made to Carestream Customer Care at 1-800-328-2910, your local service support number, or your Carestream Health Authorized Representative to schedule a service call. Customers with any questions are to call the Carestream Customer Care Center. If you have any questions or concerns please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24-hour basis. Outside of the U.S., please call your local Carestream Service support number.
• Quantity in Commerce: 3,961 units
• Distribution: Worldwide Distribution: US (Nationwide Distribution); and OUS (Foreign): Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Dominican Rep., Finland, France, Germany, Ghana, Great Britain, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Macau, Malaysia, Maldives, Mexico, Monaco, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Republic of Korea, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, & Vietnam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = IZL and Original Applicant = Carestream Health Inc.