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    平成23年 2月25日作成
    

    医療機器改修の概要

    (クラスII)

  1. 一般名及び販売名

  2.   一般的名称: 全身用X線CT診断装置
      販売名  : (1)東芝スキャナ Aquilion TSX-101A
            (2)東芝スキャナ Aquilion TSX-201A
            (3)東芝スキャナ Aquilion ONE TSX-301A
            (4)東芝スキャナ Activion16 TSX-031A
            (5)東芝スキャナ Aquilion PRIME TSX-302A
            (6)東芝スキャナ Aquilion TSX-301B
            (7)東芝スキャナ Alexion TSX-032A
    
    
  3. 対象ロット、数量及び出荷時期

  4.   (1)型式名 :TSX-101A
       Ser.No :1532137  ,1532189  ,1582253  ,1592262  ,1592264  ,1622313  ,2522003
            2522266  ,2582022  ,2622010  ,2622012  ,2622013  ,2622014  ,2622019
            3512035  ,3512057  ,3512059  ,3522064  ,3522066  ,3522069  ,3522077
            3522082  ,3522083  ,3532101  ,3532102  ,3532109  ,3532110  ,3532114
            3532115  ,3532117  ,3532119  ,3532123  ,3542136  ,3542137  ,3562012
            3572144  ,3572193  ,3572196  ,3572203  ,3582001  ,3582002  ,3582008
            3592009  ,3592010  ,3592015  ,3592016  ,3602021  ,3602023  ,3612028
            3612030  ,3612032  ,3622037  ,3622048  ,3622049  ,3622274  ,4512053
            4512055  ,4512059  ,4522064  ,4522071  ,4522072  ,4522073  ,4522078
            4522079  ,4522346  ,4532080  ,4542014  ,4552084  ,4562067  ,4562071
            4562074  ,4562076  ,4562078  ,4572029  ,4572044  ,4572083  ,4572091
            4582008  ,4582012  ,4582013  ,4582089  ,4582100  ,4582114  ,4582116
            4592010  ,4592017  ,4592127  ,4592128  ,4592129  ,4592134  ,4592144
            4592145  ,4592146  ,4592147  ,4592148  ,4602004  ,4602153  ,4602164
            4612007  ,4612009  ,4612012  ,4612012  ,4612013  ,4612180  ,4612182
            4612188  ,4612189  ,4622014  ,4622016  ,4622017  ,4622018  ,4622024
            4622030  ,4622033  ,4622038  ,4622039  ,4622041  ,4622042  ,4622198
            4622201  ,4622204  ,4622206  ,4622210  ,4622212  ,4622213  ,4622215
            4622217  ,4622219  ,4622220  ,5512052  ,5512222  ,5512225  ,5512233
            5512238  ,5512239  ,5512244  ,5522022  ,5522078  ,5522096  ,5522098
            5522248  ,5522255  ,5522262  ,5522263  ,5522270  ,5522273  ,5522277
            5522278  ,5522279  ,5522280  ,5532001  ,5532002  ,5532003  ,5532004
            5532005  ,5532006  ,5532007  ,5532008  ,5532009  ,5532010  ,5532011
            5532012  ,5532013  ,5532099  ,5532102  ,5532112  ,5532292  ,5532293
            5532298  ,5532300  ,5532301  ,5532304  ,5532306  ,5532307  ,5532308
            5532309  ,5532310  ,5532311  ,5532312  ,6AA0312045,6AA3572194,6BA0342138
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            NAA1072195,NAA1072197,NAA1082200,NAA1082201,NAA1082204,NAA1082207,NAA1082208
            NAA1082209,NAA1082210,NAA1082211,NAA1082213,NAA1082214,NAA1092215,NAA1092216
            NAA1092217,NAA1092218,NAA1092219,NAA1092220,NAA1092221,NAA1092222,NAA1092226
            NAA1092227,NBA0942004,NBA0942006,NBA0952014,NBA0972033,NBA0992056,NBA0992059
            NBA0992063,NBA0992071,NBA0992073,NBA09Z2101,NBA09Z2107,NBA09Z2109,NBA1012113
            NBA1022117,NBA1022124,NBA1022133,NBA1032152,NBA1042170,NBA1042173,NBA1042174
            NBA1042176,NBA1052177,NBA1082202,NBA1092224,NBA1092228,PBA1072001
    
      (2)型式名 :TSX-201A
       Ser. No :1AB05X2004,1AB0612005,1AB0612006,1AB0612007,1AB0652010,1AB0672013,1AB06Z2024
            1AB06Z2026,1AB0712027,1AB0722028,1AB0722030,1AB0732034,1AB0732035,1AB0742037
            1AB0792048,1AB07X2051,1AB07Y2058,1AB07Z2062,1AB07Z2064,1AB07Z2065,1AB0812068
            1AB0822071,1AB0822072,1AB0822073,1AB0822074,1AB0832075,1AB0832076,1AB0832077
            1AB0842078,1AB0842080,1AB0852081,1AB0862085,1AB0892093,1AB0892094,1AC0912102
            1AC0912106,1AC0922110,1AC0922111,1AC0922115,1AC0922118,1AC0932119,1AC0942124
            1AC0962134,1AC0982138,1AC0982139,1AC0982141,1AC09X2146,1AC09Y2159,1AC09Z2163
            1BB0812069,1IC1012168,1IC1012172,1IC1012173,1ID1022174,1ID1022175,1ID1022176
            1ID1022177,1ID1022178,1ID1022179,1ID1022181,1ID1022183,1ID1032184,1ID1032185
            1ID1032187,1ID1032189,1ID1032190,1ID1032191,1ID1032192,1ID1032193,1ID1082210
            1ID1082214,1ID1092224,1JC1012171
    
      (3)型式名 :TSX-301A
       Ser. No :2AA07X2001,2AA07Y2011,2AA0812013,2AA0822016,2AA0832018,2AA0832019,2AA0832020
            2AA0832021,2AA0882055,2AA0892056,2AA0892057,2AA0892058,2AA08X2059,2AA08X2073
            2AA08Y2074,2AA08Y2078,2AA08Y2081,2AA08Y2082,2AA08Y2083,2AA08Y2084,2AA08Y2085
            2AA08Y2086,2AA08Y2087,2AA08Z2095,2AA0922101,2AA0922103,2AA0922104,2AA0922105
            2AA0942107,2AA0942108,2AA0942110,2AA0952113,2AA0962117,2AA0972121,2AA0982128
            2AA0992135,2AA09X2140,2AA09X2141,2AA09X2144,2AA09Y2145,2AA09Y2147,2AA09Y2153
            2AA1012171,2AA1012172,2AA1012173,2AA1022177,2AA1022178,2AA1022179,2AA1022181
            2AA1022182,2AA1032184,2AA1032186,2AA1042194,2AA1062209,2AB1042189,2AB1072217
            2AB1072218,2AB1082225,2AB1082227,2AB1092228,2AB1092229,2AC1092230,2AC1092231
            2AC1092233,2AC1092236,2BB1082224
    
      (4)型式名 :TSX-031A
       Ser. No :1AA0762003,1AA0762006,1AA0772014,1AA0772019,1AA0772023,1AA0772025,1AA0782030
            1AA0782032,1AA0782033,1AA0782034,1AA0792037,1AA0792038,1AA0792043,1AA0792048
            1AA07X2050,1AA07X2056,1AA07X2061,1AA07Y2073,1AA07Y2075,1AA07Y2076,1AA07Z2083
            1AA07Z2088,1AA07Z2090,1AA0812093,1AA0812098,1AA0812100,1AA0812102,1AA0812104
            1AA0812105,1AA0812109,1AA0812112,1AA0822119,1AA0822124,1AA0822125,1AA0832139
            1AA0832143,1AA0832145,1AA0862180,1AA0862181,1AA0862182,1AA0872202,1AA0872204
            1AA0872212,1AA0882221,1AA0882222,1AA0882226,1AA0892233,1AA08Y2267,1AA08Z2269
            1AA08Z2273,1AA08Z2274,1AA08Z2278,1AA08Z2280,1AA08Z2281,1AA0912298,1AA0912300
            1AA0912302,1AA0912307,1AA0912315,1AA0912322,1AA0922335,1AA0922344,1AA0922347
            1AA0922348,1AA0922349,1AA0922351,1AA0922352,1AA0922353,1AA0922354,1AA0932362
            1AA0932365,1AA0932368,1AA0932374,1AA0932376,1AA0932380,1AA0932383,1AA0932398
            1AA0932399,1AA0952411,1AA0962417,1AA0972438,1AA0972447,1AA0972450,1AA0982455
            1AA0982474,1AC0992479,1AC0992491,1AC0992494,1AC0992496,1AC0992505,1AC09Y2549
            1AC1012627,1AC1012629,1AC1012634,1AC1012635,1AC1022638,1AC1022639,1AC1022644
            1AC1022647,1AC1022656,1AC1022663,1AC1032666,1AC1032669,1AC1032672,1AC1032676
            1AC1032684,1AC1032690,1AC1032692,1AC1042706,1AC1042708,1AC1042714,1AC1052721
            1AC1052730,1AC1052739,1AC1052741,1AC1062743,1AC1062754,1AC1062757,1AC1062759
            1AC1062760,1AC1072792,1AC1072797,1AC1072800,1AC1072803,1AC1072812,1AC1072815
            1AC1072816,1AC1082835,1AC1082837,1AC1082846,1AC1082847,1AC1082849,1AC1082850
            1AC1092869,1AC1092871,1AC1092872,1AC1092874,1AC1092881,1AC1092882,1BA0742002
            1BA0772008,1BA0772009,1BA0772010,1BA0772015,1BA0772016,1BA0772020,1BA0772026
            1BA0782035,1BA0782036,1BA0792039,1BA0792040,1BA0792044,1BA0792046,1BA0792047
            1BA0792049,1BA07X2059,1BA07X2060,1BA07X2062,1BA07Y2070,1BA07Y2071,1BA07Y2072
            1BA07Z2077,1BA0812095,1BA0812099,1BA0812106,1BA0812107,1BA0812108,1BA0812110
            1BA0812111,1BA0822115,1BA0822116,1BA0822118,1BA0822122,1BA0822126,1BA0822127
            1BA0832128,1BA0832140,1BA0832144,1BA0832146,1BA0842149,1BA0842153,1BA0842154
            1BA0842156,1BA0842157,1BA0842159,1BA0852161,1BA0852165,1BA0852167,1BA0852168
            1BA0852171,1BA0852172,1BA0852173,1BA0852174,1BA0852175,1BA0852176,1BA0852177
            1BA0862178,1BA0862185,1BA0862186,1BA0872197,1BA0872198,1BA0872199,1BA0872200
            1BA0872201,1BA0872203,1BA0872205,1BA0872206,1BA0872207,1BA0872208,1BA0872209
            1BA0872213,1BA0882220,1BA0882223,1BA0882224,1BA0882227,1BA0892230,1BA0892236
            1BA0892237,1BA08X2241,1BA08X2242,1BA08X2245,1BA08X2246,1BA08X2248,1BA08Y2250
            1BA08Y2251,1BA08Y2253,1BA08Y2256,1BA08Y2257,1BA08Y2258,1BA08Y2260,1BA08Y2265
            1BA08Z2271,1BA08Z2276,1BA08Z2279,1BA08Z2282,1BA08Z2284,1BA08Z2285,1BA08Z2286
            1BA08Z2295,1BA08Z2296,1BA0912305,1BA0912313,1BA0912316,1BA0912317,1BA0912319
            1BA0912326,1BA0912328,1BA0912329,1BA0912330,1BA0922336,1BA0922337,1BA0922340
            1BA0922341,1BA0922342,1BA0922345,1BA0922355,1BA0922358,1BA0932360,1BA0932361
            1BA0932363,1BA0932364,1BA0932366,1BA0932367,1BA0932369,1BA0932370,1BA0932372
            1BA0932373,1BA0932375,1BA0932377,1BA0932378,1BA0932381,1BA0932384,1BA0932385
            1BA0932387,1BA0932388,1BA0932389,1BA0932390,1BA0932391,1BA0932392,1BA0932393
            1BA0932394,1BA0932395,1BA0972440,1BA0972449,1BA0972452,1BA0982467,1BA0982475
            1BA0982476,1BC0992477,1BC0992478,1BC0992480,1BC0992482,1BC0992483,1BC0992484
            1BC0992490,1BC0992495,1BC0992497,1BC0992498,1BC0992502,1BC0992503,1BC0992506
            1BC0992508,1BC09Y2538,1BC09Z2595,1BC1012606,1BC1012608,1BC1012609,1BC1012612
            1BC1012614,1BC1012616,1BC1012628,1BC1012630,1BC1012632,1BC1012633,1BC1022640
            1BC1022642,1BC1022643,1BC1022645,1BC1022646,1BC1022648,1BC1022649,1BC1022651
            1BC1022653,1BC1022655,1BC1022661,1BC1032667,1BC1032668,1BC1032670,1BC1032673
            1BC1032674,1BC1032675,1BC1032678,1BC1032679,1BC1032680,1BC1032681,1BC1032682
            1BC1032683,1BC1032685,1BC1032686,1BC1032687,1BC1032689,1BC1042694,1BC1042697
            1BC1042699,1BC1042701,1BC1042703,1BC1042705,1BC1042709,1BC1042710,1BC1042711
            1BC1042715,1BC1052718,1BC1052719,1BC1052722,1BC1052731,1BC1052732,1BC1052733
            1BC1052734,1BC1052736,1BC1052737,1BC1052738,1BC1052740,1BC1062744,1BC1062745
            1BC1062752,1BC1062780,1BC1062781,1BC1062783,1BC1062786,1BC1062788,1BC1072789
            1BC1072793,1BC1072796,1BC1072798,1BC1072801,1BC1072804,1BC1072805,1BC1072809
            1BC1072813,1BC1072814,1BC1072817,1BC1072818,1BC1072819,1BC1072820,1BC1072822
            1BC1072823,1BC1072824,1BC1072826,1BC1072827,1BC1072828,1BC1082838,1BC1082839
            1BC1082842,1BC1082843,1BC1082844,1BC1082851,1BC1082853,1BC1082854,1BC1082855
            1BC1082856,1BC1082857,1BC1082858,1BC1082859,1BC1082860,1BC1082861,1BC1092885
            1BC1092886,1IA0972439,1IA0972441,1IA0972451,1IA0982459,1IA0982470,1IC0992486
            1IC0992489,1IC0992493,1IC0992501,1IC09X2534,1IC09Z2590,1IC09Z2598,1JA0972444
            1JA0972446,1JA0982466,1JA0982471,1JA0982473,1JC0992507,1JC09X2513,1JC09X2516
            1JC09X2521,1JC09X2527,1JC09Y2542,1JC09Y2550,1JC09Y2556,1JC09Y2560,1JC09Y2562
            1JC09Z2569,1JC09Z2572,1JC09Z2581
    
      (5)型式名 :TSX-302A
       Ser. No :1AA10Z2006,1AA10Z2009
    
      (6)型式名 :TSX-301B
       Ser. No :1AC10Z2023
    
      (7)型式名 :TSX-032A
       Ser. No :1BA1112011,1BA1112016,1BA1112017,1BA1112018,1BA1112021,1BA1112024,1BA1122026
            1BA1122029,1JA10Z2002,1JA10Z2003,1JA10Z2004,1JA10Z2006,1JA10Z2008,1JA1112015
            1JA1112019,1JA1122028
    
      数量     :1896 台
      出荷時期   :平成 13年 3月〜平成 23年 2月
    
    
  5. 製造販売業者等名称

  6.   製造販売業者の名称 : 東芝メディカルシステムズ株式会社
      製造販売業者の所在地: 栃木県大田原市下石上1385番地
      許可の種類     : 第一種医療機器製造販売業
      許可番号      : 09B1X00003
      製造所の名称    : 東芝メディカルシステムズ株式会社
      製造所の住所    : 栃木県大田原市下石上1385番地
      薬事の業態     : 医療機器製造業
      製造業許可番号   : 09BZ006008
    
    
  7. 改修理由

  8.   当該装置には、造影剤を使用したCT検査対応の為、組合わせ可能な造影剤注入装置の作動タイミングとCTス
      キャンタイミングを連動させる機能(インジェクタ同期スキャンシステム)が搭載されております。しかしな
      がら、特定の時期に出荷された装置において、本機能の取扱説明が装置の取扱説明書に記載されていないこ
      とが判明いたしました。
      なお、装置据付時には、弊社アプリケーションスペシャリスト、またはカスタマーエンジニアにより、イン
      ジェクタ同期スキャンシステムの取扱説明を実施させていただいております。さらに、造影剤注入装置本体
      の取扱説明は製造メーカにより実施されております。また、取扱説明書も提供されております。
      お客様におかれましては、これらの取扱説明に従って適切な操作を実施いただいていると考えております。
      なお、これまでに本機能の操作に関する問い合わせは受けておりません。
      弊社といたしましては、本機能の取扱説明書をお客様に提供する対応を改修として実施することにいたしま
      した。
    
    
  9. 危惧される具体的な健康被害

  10.   CT装置と造影剤注入装置の動作については同期制御が可能となっているが、動作条件等が設定されないまま使
      用された場合、造影剤が注入されずにCTスキャンだけが行われる事象(不要被曝)、または造影剤が注入されて
      いるにも関わらずCTスキャンが行われない事象(無駄な造影剤投与)が発生する可能性があると考えておりま
      すが、本事象が発生した場合でも、患者に重篤な健康被害のおそれはまず考えられない状況です。
      なお、これまでに本問題による健康被害発生の報告は受けておりません。
    
    
  11. 改修開始年月日

  12.   平成23年2月25日
    
    
    
  13. 効能・効果又は用途等

  14.   CT装置はX線管と検出器を対向に配置して、被検者の周りを回転走査させることによって、頭部を含めた全身
      の横断断層像を得る装置で、医師もしくは診療放射線技師等の有資格者が使用します。
    
    
  15. その他

  16.   納入しました医療機関は全て特定しており、全対象装置への対応を改修として実施いたします。
    
    
  17. 担当者及び連絡先

  18.   担当者 : 熊埜御堂 靖志、中原 朋哉
      連絡先 : 東芝メディカルシステムズ株式会社
           栃木県大田原市下石上1385番地
      電話番号: 0287-26-6211
      FAX番号 : 0287-26-6050