Events

Rappel de Device Recall TSXIOIA: Aquilion 32/64 ONE; System, XRay, Tomography, Computed

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Toshiba American Medical Systems Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    66527
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1113-2014
  • Date de mise en oeuvre de l'événement
    2013-10-01
  • Date de publication de l'événement
    2014-03-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122559
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, x-ray, tomography, computed - Product Code JAK
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    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
  • Adresse du fabricant
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92780-7047
  • Société-mère du fabricant (2017)
    Canon Inc
  • Source
    USFDA