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    平成29年 5月10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: (1)〜(9) 汎用超音波画像診断装置
           (10) 超音波装置ワークステーション
    販売名  : (1)超音波診断装置 Aplio i900 TUS-AI900
           (2)超音波診断装置 Aplio i800 TUS-AI800
           (3)超音波診断装置 Aplio i700 TUS-AI700
           (4)超音波診断装置 APLIO 500 TUS-A500
           (5)超音波診断装置 APLIO 400 TUS-A400
           (6)超音波診断装置 APLIO 300 TUS-A300
           (7)超音波診断装置 XARIO 200 TUS-X200
           (8)超音波診断装置 XARIO 200 TUS-X200S
           (9)超音波診断装置 XARIO 100 TUS-X100
           (10)超音波ワークステーションパッケージ UltraExtend FX TUW-U001
    
    
  3. 対象ロット、数量及び出荷時期

  4. (1) 形式名 :TUS-AI900
      Ser.No. :99A1632001,99A1632002,99A1632003,99A1632004,99A1642014,99A1642015,99A1642016
           99A1642017,99A1642018,99A1642019,99A1642020,99A1642021,99A1642022,99A1642023
           99B1672061,99B1672063,99B1692045,99B1692075,99B1692079,99B1692083,99B1692084
           99B16X2085,99B16X2093,99C16Z2095,99D1722096,99D1722097,99D1732098
    
      数量   : 27台
      出荷時期 : 平成 28年 5月〜平成 29年 3月
    
    
    (2) 形式名 :TUS-AI800
      Ser.No. :99B1672001,99B1672002,99B1672003,99B1672004,99B1672005,99B1672006,99B1672007
           99B1672008,99B1672009,99B1672010,99B1672012,99B1672013,99B1672014,99B1672015
           99B1672016,99B1672017,99B1672018,99B1672019,99B1672020,99B1672021,99B1682023
           99B1682027,99B1692029,99B1692032,99B1692033,99B1692034,99B1692035,99B1692036
           99B1692037,99B1692038,99B1692039,99B1692040,99B16X2041,99B16Y2042,99B16Y2045
           99C16Z2046,99C16Z2048,99C16Z2049,99C16Z2050,99C16Z2051,99C16Z2052,99C16Z2053
           99C16Z2054,99C16Z2055,99C16Z2057,99C1712058,99C1712059,99C1712060,99C1712061
           99C1712062,99C1712063,99D1722064,99D1722065,99D1722066,99D1722067,99D1722068
           99D1722069,99D1722070,99D1722071,99D1722072,99D1722073,99D1722074,99D1722075
           99D1722076,99D1722077,99D1722078,99D1732079,99D1732080,99D1732081,99D1732082
           99D1732088,99D1732089,99D1732095,99D1732099,99D1732100,99D1732101,99D1732102
           99D1732103,99D1732104,99D1732105,99D1732106,99D1732107,99D1742108,99D1742109
    
      数量   : 84台
      出荷時期 : 平成 28年 5月〜平成 29年 3月
    
    (3) 形式名 :TUS-AI700
      Ser.No. :99B1672001,99B1672002,99B1672003,99B1672004,99B1672005,99B1672006,99B1672007
           99B1672008,99B1672009,99B1672010,99B1672011,99B1672012,99B1672013,99B1672014
           99B1672015,99C16Z2017,99C16Z2018,99C16Z2019,99D1722020,99D1722021,99D1722022
           99D1722023,99D1722024,99D1722025,99D1722026,99D1722027,99D1732028,99D1732029
           99D1732030,99D1732031,99D1732032,99D1732037,99D1732038,99D1732039
    
      数量   : 34台
      出荷時期 : 平成 28年 5月〜平成 29年 3月
    
    (4) 形式名 :TUS-A500
      Ser.No. :JAA1542002,JAA1552021,JAA1562032,JAB15X2067,JAB15Y2084,JAB15Z2124,JAB1622169
           JAB1622184,JAB1632193,JAB1632197,JAB1632199,JAB1632200,JAB1632201,JAC1642206
           JAC1642207,JAC1642208,JAC1642209,JAC1642210,JAC1652212,JAC1652213,JAC1652215
           JAC1652216,JAC1652217,JAC1652218,JAC1652219,JAC1652220,JAC1652221,JAC1652222
           JAC1652223,JAC1652224,JAC1652225,JAC1652226,JAC1652227,JAC1652228,JAC1652229
           JAC1652230,JAC1652231,JAC1672232,JAC1672233,JAC1672234,JAC1672235,JAC1672236
           JAC1672237,JAC1672238,JAC1672239,JAC1672240,JAC1672241,JAC1682242,JAC1682243
           JAC1682244,JAC1682245,JAC1682246,JAC1682247,JAC1682248,JAC1682249,JAC1682250
           JAC1682252,JAC1682253,JAC1682254,JAC1692255,JAC1692256,JAC1692257,JAC1692258
           JAC16X2259,JAC16X2260,JAC16X2261,JAC16X2262,JAC16Y2263,JAC16Y2264,JAC16Y2265
           JAC16Y2266,JAC16Y2267,JAC16Y2268,JAC16Y2269,JAC16Y2271,JAC16Y2272,JAD16Z2273
           JAD16Z2274,JAD16Z2275,JAD16Z2276,JAD16Z2277,JAD16Z2278,JAD16Z2279,JAE1712281
           JAE1712282,JAE1712283,JAE1712284,JAE1712285,JAE1712286,JAE1712287,JAE1712289
           JAE1712290,JAE1712291,JAE1712292,JAE1712293,JAE1712294,JAF1722295,JAF1722296
           JAF1722297,JAF1722298,JAF1722299,JAF1722300,JAF1722301,JAF1722302,JAF1722304
           JAF1722305,JAF1722306,JAF1722307,JAF1722308,JAF1722310,JAF1722312,W1B1182108
           W1C1222427,W1C1222432,W1D1252714,W1D1262811,W1D1272863,W1D1282923,W1E1333861
           W1E1333878,W1E1344073,W1E1364182,W1E13Z4839,W1E13Z4886,W1F1414993,W1F1425125
           W1F1465366,W5A1492014,W5A14Y2168,W5A1512269,W5A1512351,W5B1532461,W5B1532487
    
      数量   : 133台
      出荷時期 : 平成 28年 4月〜平成 29年 3月
    
    (5) 形式名 :TUS-A400
      Ser.No. :JAA1592082,JAB15X2089,JAB15X2096,JAB15Z2132,JAB1622199,JAB1632216,JAB1632230
           JAC1642240,JAC1642241,JAC1642242,JAC1642243,JAC1642244,JAC1642245,JAC1642246
           JAC1642247,JAC1642248,JAC1642249,JAC1642250,JAC1642251,JAC1642252,JAC1642253
           JAC1642254,JAC1642255,JAC1642256,JAC1642257,JAC1642258,JAC1642259,JAC1642260
           JAC1642261,JAC1642262,JAC1642263,JAC1642264,JAC1642265,JAC1652266,JAC1652267
           JAC1652268,JAC1652269,JAC1652270,JAC1652271,JAC1652272,JAC1652273,JAC1652274
           JAC1652275,JAC1652276,JAC1652277,JAC1652278,JAC1652280,JAC1652281,JAC1652282
           JAC1652283,JAC1652284,JAC1652285,JAC1652286,JAC1652287,JAC1652288,JAC1652289
           JAC1652290,JAC1652291,JAC1652292,JAC1652293,JAC1662294,JAC1662295,JAC1662296
           JAC1662297,JAC1662298,JAC1662299,JAC1662300,JAC1662301,JAC1662302,JAC1672303
           JAC1672304,JAC1672305,JAC1672306,JAC1672307,JAC1672308,JAC1672309,JAC1672310
           JAC1672311,JAC1672312,JAC1672313,JAC1672314,JAC1672315,JAC1672316,JAC1672317
           JAC1672318,JAC1672319,JAC1672320,JAC1672321,JAC1672322,JAC1682323,JAC1682324
           JAC1682325,JAC1682326,JAC1682327,JAC1682328,JAC1692329,JAC1692330,JAC1692331
           JAC1692332,JAC1692333,JAC1692334,JAC1692335,JAC1692336,JAC1692337,JAC1692338
           JAC1692339,JAC1692340,JAC1692341,JAC1692342,JAC1692343,JAC1692344,JAC1692345
           JAC1692346,JAC1692347,JAC1692348,JAC1692349,JAC1692350,JAC1692351,JAC1692352
           JAC1692353,JAC1692354,JAC16X2355,JAC16X2356,JAC16X2357,JAC16X2358,JAC16X2359
           JAC16X2360,JAC16X2361,JAC16X2362,JAC16X2363,JAC16X2368,JAC16Y2364,JAC16Y2365
           JAC16Y2366,JAC16Y2367,JAC16Y2369,JAC16Y2370,JAC16Y2371,JAC16Y2372,JAC16Y2373
           JAC16Y2374,JAC16Y2375,JAC16Y2376,JAC16Y2377,JAC16Y2378,JAD16Z2379,JAD16Z2380
           JAD16Z2381,JAD16Z2382,JAD16Z2383,JAD16Z2384,JAD16Z2385,JAD16Z2386,JAD16Z2387
           JAD16Z2388,JAD16Z2389,JAD16Z2390,JAD16Z2391,JAD16Z2392,JAD16Z2393,JAE1712394
           JAE1712395,JAE1712396,JAE1712397,JAE1712398,JAE1712399,JAE1712400,JAE1712401
           JAE1712402,JAE1712403,JAE1712404,JAE1712405,JAE1712406,JAE1712407,JAE1712408
           JAE1712409,JAE1712410,JAE1712411,JAE1712412,JAE1712413,JAE1712415,JAE1712416
           JAE1712417,JAE1712418,JAE1712419,JAE1712420,JAE1712421,JAE1712422,JAE1712423
           JAF1722425,JAF1722426,JAF1722427,JAF1722428,JAF1722429,JAF1722430,JAF1722431
           JAF1722432,JAF1722433,JAF1722435,JAF1722437,JAF1722438,JAF1722439,JAF1722440
           JAF1722441,JAF1722442,JAF1722443,JAF1722444,JAF1722446,JAF1722447,JAF1722448
           JAF1722449,JAF1722450,JAF1722451,JAF1722452,JAF1722453,JAF1722454,JAF1722455
           JAF1722456,JAF1722457,JAF1722458,JAF1732459,JAF1732462,JAF1732465,W1C11Z2245
           W1D1262630,W1D1272736,W1D1282779,W1D1282813,W1D1292942,W1D12X2964,W1E1323344
           W1E1373757,W1E1393893,W1E13Y4018,W1E13Z4083,W1E13Z4086,W1F1424207,W1F1424215
           W1F1434241,W1F1434265,W1F1434275,W1F1464411,W5A1492026,W5A1512176,W5B1522201
           W5B1552353
    
      数量   : 246台
      出荷時期 : 平成 28年 4月〜平成 29年 3月
    
    (6) 形式名 :TUS-A300
      Ser.No. :JCA1552052,JCA1592159,JCA1592161,JCB15Z2215,JCB15Z2223,JCB15Z2245,JCB15Z2253
           JCB1612271,JCB1612277,JCB1622367,JCB1632382,JCB1632407,JCC1642412,JCC1642413
           JCC1642414,JCC1642415,JCC1642416,JCC1642417,JCC1642418,JCC1642419,JCC1642420
           JCC1642421,JCC1642422,JCC1642423,JCC1642424,JCC1642425,JCC1642426,JCC1642427
           JCC1642428,JCC1642429,JCC1642430,JCC1642431,JCC1642432,JCC1642433,JCC1642434
           JCC1642435,JCC1642436,JCC1642437,JCC1642438,JCC1642439,JCC1652440,JCC1652441
           JCC1652442,JCC1652443,JCC1652444,JCC1652445,JCC1652446,JCC1652447,JCC1652448
           JCC1652449,JCC1652450,JCC1652451,JCC1652452,JCC1652453,JCC1652454,JCC1652455
           JCC1652456,JCC1652457,JCC1652458,JCC1652459,JCC1652460,JCC1652461,JCC1652462
           JCC1652463,JCC1652464,JCC1652465,JCC1652466,JCC1652467,JCC1652468,JCC1652469
           JCC1652470,JCC1652471,JCC1652472,JCC1652473,JCC1652474,JCC1652475,JCC1652476
           JCC1652477,JCC1652478,JCC1652479,JCC1652480,JCC1652481,JCC1652482,JCC1652483
           JCC1662485,JCC1662486,JCC1662487,JCC1662488,JCC1662489,JCC1662490,JCC1662491
           JCC1662492,JCC1662493,JCC1662494,JCC1662495,JCC1662496,JCC1662497,JCC1662498
           JCC1662499,JCC1662500,JCC1662501,JCC1662502,JCC1662503,JCC1662505,JCC1662506
           JCC1662507,JCC1662508,JCC1662509,JCC1662510,JCC1662511,JCC1662512,JCC1662513
           JCC1662514,JCC1672515,JCC1672516,JCC1672517,JCC1672518,JCC1672519,JCC1672520
           JCC1672521,JCC1672522,JCC1672523,JCC1672524,JCC1672525,JCC1672526,JCC1672527
           JCC1672528,JCC1672529,JCC1672530,JCC1672531,JCC1672532,JCC1672533,JCC1672534
           JCC1672535,JCC1672536,JCC1672537,JCC1672538,JCC1672539,JCC1672540,JCC1672541
           JCC1672542,JCC1672543,JCC1672544,JCC1672545,JCC1672546,JCC1682547,JCC1682548
           JCC1682549,JCC1682550,JCC1682551,JCC1682552,JCC1682553,JCC1682554,JCC1682555
           JCC1682556,JCC1682557,JCC1682558,JCC1682559,JCC1692560,JCC1692561,JCC1692562
           JCC1692563,JCC1692564,JCC1692565,JCC1692566,JCC1692567,JCC1692568,JCC1692569
           JCC1692570,JCC1692571,JCC1692572,JCC1692573,JCC1692574,JCC1692575,JCC1692576
           JCC1692577,JCC1692578,JCC1692579,JCC1692580,JCC1692581,JCC16X2582,JCC16X2583
           JCC16X2584,JCC16X2585,JCC16X2586,JCC16X2587,JCC16X2588,JCC16X2589,JCC16X2590
           JCC16X2591,JCC16X2592,JCC16X2593,JCC16X2594,JCC16X2595,JCC16X2596,JCC16X2597
           JCC16X2598,JCC16X2599,JCC16Y2600,JCC16Y2601,JCC16Y2602,JCC16Y2603,JCC16Y2604
           JCC16Y2605,JCC16Y2606,JCC16Y2607,JCC16Y2608,JCC16Y2609,JCC16Y2610,JCC16Y2611
           JCC16Y2612,JCC16Y2613,JCC16Y2614,JCC16Y2615,JCC16Y2616,JCC16Y2617,JCD16Z2618
           JCD16Z2619,JCD16Z2620,JCD16Z2621,JCD16Z2622,JCD16Z2623,JCD16Z2624,JCD16Z2625
           JCD16Z2626,JCD16Z2627,JCD16Z2628,JCD16Z2629,JCD16Z2630,JCD16Z2631,JCD16Z2632
           JCD16Z2633,JCD16Z2634,JCD16Z2635,JCD16Z2636,JCD16Z2637,JCD16Z2638,JCD16Z2639
           JCD16Z2640,JCD16Z2641,JCD16Z2642,JCD16Z2643,JCD16Z2644,JCD16Z2645,JCD16Z2646
           JCD16Z2647,JCD16Z2648,JCD16Z2649,JCD16Z2650,JCD16Z2651,JCD16Z2652,JCD16Z2653
           JCD16Z2654,JCD16Z2655,JCD16Z2656,JCD16Z2657,JCD16Z2658,JCD16Z2659,JCD16Z2660
           JCD16Z2661,JCD16Z2662,JCE1712663,JCE1712664,JCE1712665,JCE1712666,JCE1712667
           JCE1712668,JCE1712669,JCE1712670,JCE1712671,JCE1712672,JCE1712673,JCE1712674
           JCE1712675,JCE1712676,JCE1712677,JCE1712678,JCE1712679,JCE1712680,JCE1712681
           JCE1712682,JCE1712683,JCE1712684,JCE1712685,JCE1712686,JCE1712687,JCE1712688
           JCE1712689,JCE1712690,JCE1712691,JCE1712692,JCE1712693,JCE1712694,JCE1712695
           JCE1712696,JCE1712697,JCE1712698,JCE1712699,JCF1722700,JCF1722701,JCF1722702
           JCF1722703,JCF1722704,JCF1722705,JCF1722706,JCF1722707,JCF1722708,JCF1722709
           JCF1722710,JCF1722711,JCF1722712,JCF1722713,JCF1722714,JCF1722715,JCF1722716
           JCF1722717,JCF1722718,JCF1722719,JCF1722720,JCF1722721,JCF1722722,JCF1722723
           JCF1722724,JCF1722725,JCF1722726,JCF1722727,JCF1722728,JCF1722729,JCF1722730
           JCF1722731,JCF1722732,JCF1722733,JCF1722734,JCF1722735,JCF1722736,JCF1722737
           JCF1722738,JCF1722739,JCF1722740,JCF1722741,JCF1722742,JCF1722743,JCF1722744
           JCF1722745,JCF1722746,JCF1722747,JCF1722748,JCF1722749,JCF1722750,JCF1722751
           JCF1722752,JCF1722753,JCF1722754,JCF1732755,JCF1732757,JCF1732758,JCF1732759
           JCF1732760,JCF1732761,JCF1732762,JCF1732763,JCF1732764,JCF1732765,JCF1732766
           JCF1732767,JCF1732768,JCF1732769,JCF1732770,JCF1732771,JCF1732772,JCF1732773
           JCF1732774,JCF1732775,JCF1732776,JCF1732777,JCF1732778,JCF1732779,JCF1732780
           JCF1732782,JCF1732783,JCF1732784,JCF1732785,JCF1732786,JCF1732787,JCF1732788
           JCF1732789,JCF1732790,JCF1732791,JCF1732792,JCF1732794,JCF1732796,JCF1732797
           JCF1732798,JCF1732800,JCF1732801,JCF1732804,JCF1732805,W1B1182056,W1C1222238
           W1D1242370,W1D1242434,W1D1282625,W1E1323196,W1E1333292,W1E1333362,W5B1522217
           W5B1532296,W5B1572431,W5B1572439
    
      数量   : 409台
      出荷時期 : 平成 28年 4月〜平成 29年 3月
    
    (7) 形式名 :TUS-X200
      Ser.No. :99C1574852,W5A1672019,W5A1672020,W5A1672026,W5B16Z2403,W5B16Z2404,W5B16Z2415
           W5B16Z2416,W5B16Z2417,W5B16Z2418,W5B16Z2419,W5B16Z2420,W5B16Z2421,W5B16Z2449
           W5B16Z2450,W5B16Z2451,W5B16Z2457,W5B16Z2458,W5B16Z2459,W5B16Z2460,W5B16Z2461
           W5C1712462,W5C1712463,W5C1712464,W5C1712467,W5C1712468,W5C1712469,W5C1712485
           W5C1712486,W5C1712487,W5C1712488,W5C1712489,W5C1712490,W5C1712496,W5C1712497
           W5C1712498,W5C1712499,W5C1712500,W5C1712501,W5C1722502,W5C1722510,W5C1722511
           W5C1722512,W5C1722513,W5C1722519,W5C1722520,W5C1722557,W5C1722558,W5C1722559
           W5C1722560,W5C1722561,W5C1722562,W5C1722563,W5C1722564,W5C1722565,W5C1722566
           W5C1722567,W5C1722568,W5C1722569,W5C1722570,W5C1722571,W5C1722572,W5C1722573
           W5C1722574,W5C1722575,W5C1722576,W5C1722577,W5C1722578,W5C1722579,W5C1722580
           W5C1722581,W5C1722582,W5C1722583,W5C1722584,W5C1722585,W5C1722586,W5C1722587
           W5C1722588,W5C1722589,W5C1722590,W5C1722591,W5C1722605,W5C1722631,W5D1732657
           W5D1732658,W5D1732659,W5D1732660,W5D1732661,W5D1732662,W5D1732663,W5D1732664
           W5D1732665,W5D1732666,W5D1732667,W5D1732668,W5D1732669,W5D1732670,W5D1732671
           W5D1732672,W5D1732673,W5D1732674,W5D1732675,W5D1732676,W5D1732677,W5D1732678
           W5D1732679,W5D1732680,W5D1732681,W5D1732682,W5D1732683,W5D1732684,W5D1732685
           W5D1732686,W5D1732687,W5D1732688,W5D1732690,W5D1732691,W5D1732692,W5D1732693
           W5D1732694,W5D1732695,W5D1732696,W5D1732702,W5D1732726,W5D1732737,W5D1732738
           W5D1732740
    
      数量   : 127台
      出荷時期 : 平成 28年 11月〜平成 29年 3月
    
    (8) 形式名 :TUS-X200S
      Ser.No. :W5B16Z2071,W5B16Z2072,W5B16Z2074,W5B16Z2075,W5B16Z2077,W5B16Z2078,W5C1712079
           W5D1722080,W5D1722081,W5D1722082,W5D1722083,W5D1722084,W5D1722085,W5D1722086
           W5D1732087,W5D1732088,W5D1732089,W5D1732090,W5D1732091,W5D1732092,W5D1732093
           W5D1732094,W5D1732095,W5D1732096,W5D1732097,W5D1732098,W5D1732099,W5D1732100
           W5D1732101,W5D1732102
    
      数量   : 30台
      出荷時期 : 平成 28年 11月〜平成 29年 3月
    
    (9) 形式名 :TUS-X100
      Ser.No. :W5A1672044,W5A16X2337,W5B16Y2442,W5B16Y2443,W5B16Y2459,W5B16Y2460,W5B16Y2461
           W5B16Y2472,W5B16Y2473,W5B16Y2474,W5B16Y2475,W5B16Y2476,W5B16Y2477,W5B16Y2478
           W5B16Y2479,W5B16Y2480,W5B16Z2481,W5B16Z2482,W5B16Z2483,W5B16Z2484,W5B16Z2504
           W5B16Z2506,W5B16Z2508,W5B16Z2509,W5B16Z2510,W5B16Z2511,W5B16Z2512,W5B16Z2513
           W5B16Z2514,W5B16Z2515,W5B16Z2516,W5B16Z2559,W5B16Z2560,W5B16Z2561,W5B16Z2562
           W5B16Z2563,W5B16Z2564,W5B16Z2565,W5B16Z2566,W5B16Z2587,W5B16Z2588,W5B16Z2589
           W5B16Z2590,W5B16Z2591,W5B16Z2592,W5B16Z2593,W5C1712612,W5C1712623,W5C1712624
           W5C1712625,W5C1712626,W5C1712627,W5C1712628,W5C1712629,W5C1712630,W5C1712631
           W5C1712632,W5C1712633,W5C1712634,W5C1712635,W5C1712636,W5C1712637,W5C1712638
           W5C1712639,W5C1712640,W5C1712641,W5C1712659,W5C1712660,W5C1712661,W5C1712662
           W5C1712663,W5C1712664,W5C1712665,W5C1712666,W5C1712667,W5C1712674,W5C1712675
           W5C1712676,W5C1712677,W5C1712678,W5C1712679,W5C1712680,W5C1712681,W5C1712682
           W5C1712683,W5C1712684,W5C1712685,W5C1712700,W5C1712701,W5C1722702,W5C1722703
           W5C1722704,W5C1722707,W5C1722713,W5C1722714,W5C1722715,W5C1722716,W5C1722719
           W5C1722761,W5C1722762,W5C1722763,W5C1722764,W5C1722765,W5C1722766,W5C1722767
           W5C1722768,W5C1722769,W5C1722770,W5C1722771,W5C1722772,W5C1722790,W5C1722791
           W5C1722792,W5C1722793,W5C1722794,W5C1722795,W5C1722796,W5C1722797,W5C1722798
           W5C1722799,W5C1722800,W5C1722801,W5C1722802,W5C1722803,W5C1722804,W5C1722814
           W5C1722815,W5C1722816,W5C1722817,W5C1722827,W5C1722828,W5C1722829,W5C1722830
           W5C1722831,W5C1722832,W5C1722833,W5C1722834,W5C1722835,W5C1722836,W5C1722837
           W5C1722838,W5C1722839,W5C1722840,W5C1722841,W5C1722842,W5C1722843,W5C1722844
           W5C1722845,W5C1722910,W5C1722911,W5C1722912,W5C1722913,W5C1722914,W5C1722915
           W5C1722916,W5C1722918,W5C1722919,W5C1722920,W5C1722921,W5C1722922,W5C1722923
           W5C1722924,W5C1722925,W5C1722926,W5C1722927,W5C1722928,W5C1722929,W5C1722930
           W5C1722931,W5C1722932,W5C1732819,W5C1732933,W5C1732934,W5C1732935,W5C1732936
           W5C1732937,W5C1732938,W5C1732939,W5C1732940,W5C1732941,W5C1732942,W5C1732943
           W5C1732944,W5C1732945,W5C1732946,W5C1732947,W5C1732948,W5C1732949,W5C1732952
           W5C1732953,W5C1732954,W5C1732955,W5C1732970,W5C1732971,W5C1732972,W5C1732973
           W5C1732974,W5C1732976,W5C1732977,W5C1732978,W5C1732979,W5C1732980,W5C1732981
           W5C1732982,W5C1732983,W5C1732984,W5C1732985,W5C1732986,W5C1732987,W5C1732988
           W5C1732989,W5C1732990,W5C1732991,W5C1732993,W5C1732994,W5C1732995,W5C1732996
           W5C1732997,W5C1732998,W5C1732999,W5C1733000,W5C1733001,W5C1733002,W5C1733003
           W5C1733004,W5C1733005,W5C1733006,W5C1733008,W5C1733009,W5C1733010,W5C1733011
           W5C1733012,W5C1733025,W5C1733026,W5C1733027,W5C1733028,W5C1733029,W5C1733030
           W5C1733031,W5C1733032,W5C1733033,W5C1733034,W5C1733035,W5C1733036,W5C1733037
           W5C1733038,W5C1733039,W5C1733040,W5C1733041,W5C1733042,W5C1733044,W5C1733045
           W5C1733046,W5C1733047,W5C1733048,W5C1733049,W5C1733050,W5C1733066,W5C1733067
           W5C1733068,W5C1733069,W5C1733070,W5C1733071,W5C1733072,W5C1733076,W5C1733077
           W5C1733078,W5C1733079,W5C1733080,W5C1733081,W5C1733082,W5C1733083,W5C1733084
    
      数量   : 273台
      出荷時期 : 平成 28年 11月〜平成 29年 3月
    
    
    (10) 形式名 :TUW-U001
       Ser.No. :71B1682010,71B1692011
    
       数量   : 2台
       出荷時期 : 平成 28年 8月〜平成 29年 3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
    製造業登録番号   : 09BZ006008
    
    
  7. 改修理由

  8. 当該超音波診断装置および超音波装置ワークステーションにおいて、心臓検査などのドプラの流速波形を
    トレースする際にトレース方法でContinuous traceを使用した場合、MPG(Mean Pressure Gradient:
    平均圧較差)値を誤って計算・表示する場合があることが判明しました。
    このため、ソフトウェアを修正する対策を改修として実施させていただきます。
    
    
  9. 危惧される具体的な健康被害

  10. 本事象が発生した場合、条件によっては計算値が50%程度低くなるため、この計算値を用いて診断を行なった場
    合、心臓の弁の機能低下の見落としや正常を誤って診断することが考えられます。しかしながら、一般に弁の機
    能診断には複数の判断基準が用いられるため、本事象により重篤な健康被害が発生する可能性は無いと考えてお
    ります。
    なお、これまでに本件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29年5月10日 (情報提供の開始)
    
    
    
  13. 効能・効果又は用途等

  14. 超音波画像診断装置は超音波を利用して人体を検査または診断する手段を提供する装置で、医師もしくは臨床検
    査技師等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等は全て特定しており、全対象装置に対策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 : 佐々木 富也
    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: 0287-26-6478
    FAX番号 : 0287-26-6747