TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography X-Ray System. This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion RXL has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

Detalles del retiro

Fabricante

Toshiba American Medical Systems Inc

Distribuidor

Nationwide Distribution.

Lote

SERIAL NUMBER JDA1062176, JDA1062177, JDA1072183, JDA1072184, JDA1072186, JDA1072187, JDA1082188, JDA1082189, JDA1082190, JDA10X2191, JDA10X2192, JDA10X2193, JDA10X2194, JDA10X2195, JDA10X2196, JDA10X2197, JDA10X2198, JDA10Y2199, JDA10Y2200, JDA10Y2201, JDA10Y2202, JDA10Y2203, JDA10Y2204, JDA10Y2205, JDA10Z2206, JDA10Z2207, JDA10Z2209, JDA10Z2210, JDA10Z2211, JDA10Z2212, JDA10Z2213, JDA10Z2214, JDA10Z2215, JDA1112216, JDA1112217, JDA1112218, JDA1112219, JDA1112221, JDA1112222, JDA1112224, JDA1112225, JDA1112226, JDA1112227, JDA1122231, JDA1122234, JDA1142236, JDA1162237, JDA1162238, JDA1162239, JDA1182240, JDA1182241, JDA1182242, JDA1182243, JDA1182244, JDA11X2245, JDA11X2246, JDA11X2247, JDA11Z2249, JDA11Z2250, JDA11Z2252, JDA11Z2253, JDA11Z2254, JDA11Z2255, JDA1222257, JDA1222258, JDA1222259, JDA1222260, JDA1222261, JDA1242264, JDA1252265, JDA1252266, JDA1252267, JDA12Z2271, JDA1312272, JGA1062178, JGA1062181, JGA1062182, JGA1112220, JGA1112228, JGA11Z2256, JGA1222262, JGA12X2269, JLA1062179, JLA1062180, JLA1072185, JLA10Z2208, JLA1122232, JLA1122233, JLA1132235, JLA11Y2248, JLA11Z2251, JLA1232263, JLA1262268, JLA12Y2270, KDA1062080, KDA1072081, KDA1072082, KDA1072083, KDA1072085, KDA1072086, KDA1072088, KDA1082090, KDA1082091, KDA1082092, KDA1092093, KDA10X2094, KDA10X2095, KDA10X2096, KDA10X2097, KDA10X2098, KDA10X2099, KDA10Y2100, KDA10Y2101, KDA10Y2102, KDA10Z2104, KDA1112107, KDA1122110, KDA1122111, KDA1132113, KDA1142114, KDA1152115, KDA1152116, KDA1152117, KDA1152118, KDA1162119, KDA1162120, KDA1162121, KDA1162122, KDA1162123, KDA1162124, KDA1172125, KDA1182126, KDA1182127, KDA1182128, KDA1182129, KDA1192130, KDA1192131, KDA11X2132, KDA11X2133, KDA11Y2134, KDA11Z2136, KDA11Z2137, KDA11Z2138, KDA11Z2139, KDA11Z2140, KDA1222141, KDA1222142, KDA1222143, KDA1232144, KDA1242145, KDA1242146, KDA1252147, KDA1272148, KDA1282149, KDA1292151, KDA12X2152, KDA12Y2153, KDA12Z2154, KDA1322155, KGA1082089, KGA10Z2103, KGA10Z2105, KGA1112106, KGA1112108, KGA1122109, KGA1122112, KGA11Z2135, KLA1072084, KLA1072087, KLA1292150, RDA1292019, RDA12X2023, RDA12X2024, RDB12Y2029, RDB12Z2032, RDB1312037, RDB1312038, RGA12X2025, RGB12Y2028, RGB1312034, 2DA0792002, 2DA0792004, 2DA07X2005, 2DA07X2008, 2DA07Y2010, 2DA0842023, 2DA0842026, 2DA0862034, 2DA0862036, 2DA0872038, 2DA0882048, 2DA0882049, 2DA0882051, 2DA0882052, 2DA0882053, 2DA08X2061, 2DA08X2067, 2DA08X2070, 2DA08X2071, 2DA08X2072, 2DA08Y2077, 2DA08Y2080, 2DA08Z2092, 2DA0952115, 2DA0962116, 2DA0972123, 2DA0982131, 2DA0982133, 2DA09X2139, 2DA09X2143, 2DA09Y2148, 2DA09Y2151, 2DA09Z2158, 2DA09Z2161, 2DA09Z2162, 2DA1012165, 2DA1012167, 2DA1012168, 2DA1012169, 2DA1012170, 2DA1012174, 2DA1062208, 2DA1072212, 2DB1082219, 2DB1082220, 2DB1082222, 2DB10X2241, 2DB10Y2253, 2DB10Y2257, 2DB10Z2265, 2DB1112275, 2DB1112283, 2DB1122284, 2DB1122291, 2DB1122294, 2DC1142308, 2DC1142311, 2DC1152316, 2DC1162324, 2DC1172328, 2DC1172332, 2DC1172333, 2DC11X2352, 2DC11Y2365, 2DC11Y2367, 2DC11Z2372, 2DC11Z2374, 2DC1212377, 2DC1212383, 2DC1232392, 2DC1232393, 2DC1232396, 2DC1232397, 2DC1232398, 2DC1242407, 2DC1242409, 2DC1252410, 2DC1262412, 2DC1272417, 2DC1272421, 2DC1282423, 2DC12X2427, 2DC12Y2430, 2DC12Y2431, 2DC12Z2433, 2DC1312435, 2DC1312436, 2DC1322437, 1DA0962006, 1DA0972007, 1DA0972008, 1DA0992011, 1DA09Y2014, 1DA1062015, 1DB1072016, 1DB1082017, 1DB1082018, 1DB1082019, 1DB10Y2020, 1DB10Y2021, 1DB10Y2022, 1DB1112025, 1DB1122027, 1DC1142030, 1DC1152031, 1DC1162032, 1DC1162033, 1DC1172035, 1DC11Y2037, 1DC11Y2038, 1DC11Z2040, 1DC1222042, 1DC1232043, 1DC1232044, 1DC1252045, 1DC1252046, 1DC1262048, 1DC1272050, 1DC1282051, 1DC1292052, 1DC12X2053, 1DC12Y2054, 1DC12Y2055, 1DC12Z2056, 1DC1312057, 1DC1312058, 1DC1342

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States