Events

Retiro De Equipo (Recall) de Device Recall TSXIOIA: Aquilion 32/64 ONE; System, XRay, Tomography, Computed

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Toshiba American Medical Systems Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    66527
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1113-2014
  • Fecha de inicio del evento
    2013-10-01
  • Fecha de publicación del evento
    2014-03-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122559
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, x-ray, tomography, computed - Product Code JAK
  • Causa
    Toshiba intitiated this recall because their investigation revealed that due to a problem of the x-ray output control software, the x-ray output conditions may not be set correctly. as a result, x-ray exposure under the scan conditions used for contrast study may not start.
  • Acción
    Toshiba sent an Urgent Medical Device Correction letter on October 1, 2013, via USPS return receipt mail and accompanied by a response form. The recall notification letter provided the Device Model, serial number, SID, problem, corrective action, request to customers, and contact information (800) 421-1968 or (800) 521-1968. Toshiba designed and test an upgraded ROM for the SC2 PWB to prevent recurrence of the fault. Service technicians will replace the ROM on site at no cost to the system owners. All repairs are expected to be completed by April 2014 and progress reports will be provided on the effectiveness of the plan. For questions regarding this recall call 714-730-5000.

Device

Device Recall TSXIOIA: Aquilion 32/64 ONE; System, XRay, Tomography, Computed
  • Modelo / Serial
    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, 1DC1342059, 1GC1262047, 1GC1272049, 1DA1222096, 1DA1222097, 1DA1232099, 1DA1232100, 1DA1232103, 1DA1252124, 1DA1252131, 2DA1252001, 2DA1262003, 2DA1272004, 2DA1272005, 2DA1272006, 2DA1282007, 2DA1292008, 2DA12X2009, 2DA12X2010, 2DA12X2012, 2DA12X2013, 2DA12Y2014, 2DA12Y2015, 2DA12Y2016, 2DA12Z2017, 2DA12Z2018, 2DA1312019, 2DA1312020, 2DA1312021, 2DA1312022, 2GA1262002, 2GA12X2011, 2DA1072211, 2DA08X2063, 2DC11Y2368.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    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.
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Dirección del fabricante
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92780-7047
  • Empresa matriz del fabricante (2017)
    Canon Inc
  • Source
    USFDA