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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2038-2012

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.

Publicado el 1 de agosto de 2012 · Inicio del retiro: 22 de febrero de 2008

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The vertical lift column power supply in the mainframe C-arm of the device is defective and subject to early life failure.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
GE OEC Medical Systems, Inc
Distribuidor
Worldwide distribution.
Lote
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,
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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