OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

Recall details

Manufacturer

GE OEC Medical Systems, Inc

Distributor

Worldwide distribution.

Lot

8S-1663 , 8S-2887 , 89-3119 , 89-0098 , 8S-0152-C , 89-0540 , 82-1252, 82-1519, 89-2326 , 89-1204 , 89-3272, 89-3273 , 8S-0258 , 82-0678, 82-1884 , 8S-2321 , 82-2042 , 82-3210 , 8S-0533 , 8S-1077 , 89-0910 , 82-0139, 82-3871, 89-1757 , 89-3298 , 89-3026 , 8S-2299, 8S-2857 , 89-2043 , 89-2533 , 89-2463 , 82-0356-RC , 8S-2120 , 89-1896 , 8S-7152-MH , 8S-7190-MH , 8S-3246 , 8S-0289 , 89-1626 , 8S-0625 , 8S-1301 , 8S-1920 , 89-1025 , 8S-1838 , 8S-1367 , 8S-1627 , 89-1112 , 8S-0076-RC , 8S-0508, 8S-1946 , 8S-3073, 8S-3105 , 8S-2324-C , 8S-0073 , 8S-0180 , 8S-2237 , 82-0126, 82-3040, 82-3710 , 8S-2647 , 89-2319 , 89-3105 , 82-2560, 89-0285, 8S-1310 , 8S-2124 , 8S-1626 , 89-1486 , 82-3426 , 82-0875 , 8S-2566 , 89-0955 , 82-1801 , 82-1568 , 82-3682 , 89-0073, 89-1118, 89-1147 , 8S-0706 , 8S-0622, 8S-0772 , 8S-1139 , 8S-2182, 8S-2183 , 8S-2184 , 8S-0567 , 8S-1974 , 89-0454, 82-1606, 82-1870, 82-2533, 82-7080-MH, 89-0039, 89-1607, 89-2108, 8S-1457 , 8S-7120-MH , 82-0956, 89-3006 , 89-3007 , 8S-7127-MH , 89-2585 , 82-0134, 82-3452, 82-3538, 89-0127 , 89-2725 , 82-0153, 82-0166, 82-1277, 82-2189, 89-0086, 8S-2413 , 89-1149 , 89-0738 , 82-2659, 82-3809 , 8S-1825 , 82-2934 , 89-0510 , 89-1087 , 82-2700, 8S-0832 , 8S-1736 , 82-2731, 82-3463 , 8S-1089, 8S-3099 , 82-0902 , 8S-2095 , 89-2575, 8S-1932-N , 8S-2856 , 8S-0663 , 82-2832 , 89-3337 , 8S-1682 , 82-2113, 89-0315 , 82-2828, 89-0865, 8S-1334 , 8S-2281, 8S-2630, 8S-2638 , 89-2064 , 8S-0658, 8S-1540 , 8S-2144, 8S-2894 , 8S-1005, 82-2782, 8S-2363 , 82-3010 , 82-2471 , 8S-0125 , 89-0096 , 89-0591 , 89-2813 , 82-7179-MH , 89-1000 , 82-0827 , 89-0493 , 82-3078, 82-3676 , 89-2081 , 82-1001, 82-1014, 89-0862 , 82-0711, 82-7109-MH, 8S-3254 , 89-2389 , 8S-0410 , 8S-3011 , 8S-2639 , 82-1474, 82-2779 , 89-0110 , 89-0873 , 89-2234, 8S-0317 , 8S-3049 , 89-3520 , 8S-0021-C , 8S-0883 , 8S-3096 , 89-0103 , 82-3810 , 8S-2525 , 8S-0274 , 82-0507 , 82-1098 , 82-1733 , 82-1972 , 82-2566 , 82-2730, 82-3027 , 82-3307 , 82-3315 , 82-3360 , 82-3470, 82-3509 , 82-3510 , 82-3577 , 82-3131 , 82-0894-RC , 82-1399 , 8S-2949 , 82-1663 , 8S-2938-C , 89-1153 , 82-2094 , 8S-1340 , 8S-2271 , 82-2626, 82-2630 , 8S-2484 , 82-0071 , 8S-3152 , 89-1563 , 82-1063 , 89-1194 , 82-0097, 82-0515 , 8S-7095-CMH , 82-2967, 89-2513 , 8S-2895 , 89-1800, 89-2589 , 8S-1525 , 89-0735 , 8S-0544 , 89-1239 , 82-0094 , 8S-0022-C , 89-3506 , 8S-0285, 8S-3176 , 8S-3147 , 89-3024, 8S-1530 , 8S-2931 , 82-1551 , 82-2844 , 82-0896-RC, 82-1002 , 8S-2688 , 8S-2312 , 8S-2309 , 82-0164, 82-0276, 82-2241, 82-3312 , 8S-2104 , 8S-2684 , 8S-1464 , 8S-1029, 8S-1034, 8S-1050 , 8S-1855 , 89-1709, 89-3269, 8S-0254 , 89-1841 , 8S-1083 , 8S-1511 , 82-2952, 89-3307 , 8S-7094-CMH , 89-0895-RC , 8S-2206 , 89-3163 , 82-7043-MH, 8S-0031 , 8S-0235-C , 82-2057 , 8S-2265 , 8S-0776 , 82-1957, 8S-0189 , 8S-2535 , 89-0448 , 89-0949 , 89-3372 , 89-0784 , 8S-2432 , 8S-1369 , 82-3872 , 82-2621, 89-2294 , 8S-1967 , 89-0297 , 89-2675 , 82-2633, 82-3564 , 82-7155-MH , 89-2615 , 8S-0413-C , 82-1178, 82-3351 , 89-0980 , 82-3175 , 82-3049 , 82-3473 , 8S-0110 , 8S-2075 , 82-2701 , 89-1465 , 89-2541 , 8S-2297 , 89-0987 , 8S-0807 , 82-1367 , 8S-1130 , 82-1013, 82-3072, 82-7174-MH , 8S-0157, 8S-1556 , 8S-3146 , 89-1550 , 89-1556 , 8S-1723 , 82-0493, 82-3089, 89-0599 89-2877, 89-2987 , 8S-1665 , 82-2403 , 89-2306 , 89-0626 , 8S-2238 , 82-1924 , 82-2975 , 89-0150 , 82-2227, 89-0444, 89-1904 , 82-0345, 82-3536 , 8S-1194-RC , 89-0556, 8S-1309 , 8S-1308 , 8S-2175 , 8S-2596 , 8S-1099 , 8S-2888 , 8S-0153 , 82-0437 , 89-2663 , 82-0317, 82-1037, 82-2331, 82-2699, 82-3643, 89-0878, 89-3226 , 89-2705, 89-2706 , 8S-2993 , 8S-2209 , 89-2628 , 89-1103, 89-3314 , 82-2800, 89-0389 , 8S-1921-RC , 82-0699, 82-1946, 82-3818, 8S-3046 , 82-1461, 89-0317, 89-0490 , 82-0997,

Risk classification

Class I

Area (FDA)

device

Country

United States