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平成28年 6月 9日作成
一般名及び販売名
一般的名称： 汎用超音波画像診断装置 販売名 ： (1)超音波診断装置 XARIO 200 TUS-X200 (2)超音波診断装置 XARIO 200 TUS-X200S (3)超音波診断装置 XARIO 100 TUS-X100
対象ロット、数量及び出荷時期
(1)形式名 : TUS-X200 （929台） Ser. No : 99A1352006,99A1352007,99A1352008,99A1362010,99A1362011,99A1362012,99A1362013 99A1362014,99A1362015,99A1362016,99A1362017,99B1372029,99B1372030,99B1372031 99B1372032,99B1372033,99B1372034,99B1372035,99B1372036,99B1372037,99B1372038 99B1372039,99B1372040,99B1372041,99B1372042,99B1372043,99B1372044,99B1372045 99B1372046,99B1372047,99B1372048,99B1372049,99B1372050,99B1372051,99B1382052 99B1382053,99B1382054,99B1382055,99B1382056,99B1382069,99B1382070,99B1382071 99B1382072,99B1382073,99B1382074,99B1382075,99B1382076,99B1382077,99B1382078 99B1382079,99B1382100,99B1382101,99B1382102,99B1382103,99B1382104,99B1382105 99B1382106,99B1382107,99B1382108,99B1382109,99B1382110,99B1382111,99B1382112 99B1382113,99B1382114,99B1382129,99B1382130,99B1382131,99B1382132,99B1382133 99B1392159,99B1392160,99B1392161,99B1392162,99B1392163,99B1392164,99B1392165 99B1392180,99B1392181,99B1392182,99B1392183,99B1392184,99B1392185,99B1392186 99B1392187,99B1392188,99B1392189,99B1392190,99B1392191,99B1392192,99B1392193 99B1392194,99B1392195,99B1392196,99B1392197,99B1392198,99B1392199,99B1392200 99B1392201,99B1392202,99B1392203,99B1392204,99B1392205,99B1392206,99B1392207 99B1392216,99B1392217,99B1392218,99B1392219,99B1392220,99B1392221,99B1392222 99B1392223,99B1392224,99B1392225,99B1392226,99B1392227,99B1392228,99B1392229 99B1392230,99B1392231,99B1392232,99B1392233,99B1392234,99B1392235,99B1392236 99B1392237,99B1392238,99B1392239,99B1392251,99B1392252,99B1392253,99B13X2254 99B13X2255,99B13X2256,99B13X2257,99B13X2258,99B13X2259,99B13X2260,99B13X2261 99B13X2264,99B13X2265,99B13X2266,99B13X2288,99B13X2289,99B13X2290,99B13X2291 99B13X2296,99B13X2297,99B13X2298,99B13X2299,99B13X2301,99B13X2302,99B13X2303 99B13X2304,99B13X2305,99B13X2315,99B13X2316,99B13X2317,99B13X2318,99B13X2319 99B13X2320,99B13X2321,99B13X2322,99B13X2323,99B13X2324,99B13X2325,99B13X2326 99B13X2327,99B13X2340,99B13X2341,99B13Y2374,99B13Y2375,99B13Y2376,99B13Y2381 99B13Y2388,99B13Y2389,99B13Y2390,99B13Y2391,99B13Y2392,99B13Y2393,99B13Y2394 99B13Y2405,99B13Y2406,99B13Y2407,99B13Y2412,99B13Y2413,99B13Y2414,99B13Y2418 99B13Y2419,99B13Y2420,99B13Y2428,99B13Y2429,99B13Y2430,99B13Y2431,99B13Y2432 99B13Y2433,99B13Y2434,99B13Y2435,99B13Y2436,99B13Y2450,99B13Y2451,99B13Y2452 99B13Y2453,99B13Y2454,99B13Y2456,99B13Y2457,99B13Y2458,99B13Y2459,99B13Z2463 99B13Z2464,99B13Z2465,99B13Z2466,99B13Z2467,99B13Z2468,99B13Z2470,99B13Z2480 99B13Z2491,99B13Z2492,99B13Z2493,99B13Z2494,99B13Z2495,99B13Z2496,99B13Z2497 99B13Z2498,99B13Z2499,99B13Z2500,99B13Z2518,99B13Z2519,99B13Z2520,99B13Z2521 99B13Z2522,99B13Z2523,99B13Z2524,99B13Z2525,99B13Z2526,99B13Z2539,99B13Z2540 99B13Z2541,99B13Z2542,99B13Z2543,99B13Z2544,99B13Z2545,99B13Z2546,99B13Z2547 99B13Z2548,99B13Z2549,99B13Z2551,99B13Z2552,99B13Z2553,99B13Z2554,99B13Z2555 99B1412573,99B1412574,99B1412575,99B1412576,99B1412577,99B1412578,99B1412579 99B1412580,99B1412581,99B1412582,99B1412592,99B1412593,99B1412609,99B1412610 99B1412611,99B1412612,99B1412613,99B1412614,99B1412615,99B1412616,99B1412617 99B1412618,99B1412619,99B1412620,99B1412627,99B1412628,99B1412629,99B1412630 99B1412631,99B1412632,99B1412633,99B1412634,99B1412635,99B1412647,99B1412671 99B1412672,99B1412673,99B1412674,99B1412675,99B1412707,99B1412708,99B1412709 99B1412723,99B1412724,99B1412757,99B1412758,99B1412759,99B1412760,99B1412761 99B1412762,99B1412763,99B1412764,99B1412765,99B1412766,99B1412767,99B1412768 99B1412769,99B1412770,99B1412771,99B1422772,99B1422773,99B1422774,99B1422775 99B1422776,99B1422777,99B1422778,99B1422779,99B1422780,99B1422781,99B1422782 99B1422783,99B1422784,99B1422785,99B1422786,99B1422787,99B1422788,99B1422789 99B1422790,99B1422791,99B1422792,99B1422793,99B1422794,99B1422795,99B1422796 99B1422797,99B1422798,99B1422799,99B1422800,99B1422801,99B1422802,99B1422803 99B1422804,99B1422805,99B1422806,99B1422807,99B1422808,99B1422809,99B1422810 99B1422811,99B1422812,99B1422813,99B1422814,99B1422815,99B1422816,99B1422817 99B1422818,99B1422819,99B1422820,99B1422821,99B1422823,99B1422824,99B1422825 99B1422826,99B1422828,99B1422829,99B1422830,99B1422831,99B1422832,99B1422836 99B1422837,99B1422838,99B1422839,99B1422840,99B1422886,99B1422887,99B1422888 99B1422889,99B1422906,99B1422917,99B1422918,99B1422919,99B1432920,99B1432921 99B1432922,99B1432923,99B1432924,99B1432925,99B1432926,99B1432927,99B1432928 99B1432929,99B1432930,99B1432931,99B1432932,99B1432933,99B1432934,99B1432935 99B1432936,99B1432937,99B1432938,99B1432939,99B1432940,99B1432941,99B1432942 99B1432943,99B1432944,99B1432945,99B1432946,99B1432947,99B1432948,99B1432949 99B1432950,99B1432951,99B1432952,99B1432953,99B1432954,99B1432955,99B1432956 99B1432957,99B1432958,99B1432959,99B1432960,99B1432961,99B1432962,99B1432963 99B1432964,99B1432965,99B1432966,99B1432967,99B1432968,99B1432969,99B1432970 99B1432971,99B1432972,99B1432973,99B1432975,99B1432976,99B1432977,99B1432978 99B1432979,99B1432980,99B1432981,99B1432982,99B1432983,99B1432984,99B1432985 99B1432986,99B1432987,99B1432994,99B1432995,99B1432996,99B1432997,99B1432998 99B1432999,99B1433000,99B1433001,99B1433002,99B1433003,99B1433004,99B1433005 99B1433006,99B1433007,99B1433008,99B1433009,99B1433010,99B1433011,99B1433012 99B1433023,99B1433024,99B1433025,99B1433026,99B1433027,99B1433028,99B1433029 99B1433030,99B1433031,99B1433035,99B1433036,99B1433037,99B1433038,99B1433039 99B1433040,99B1433041,99B1433042,99B1433043,99B1433044,99B1433045,99B1433046 99B1433047,99B1433048,99B1433049,99B1433050,99B1433056,99B1433057,99B1433058 99B1433059,99B1433060,99B1433061,99B1433062,99B1433063,99B1433064,99B1433065 99B1433066,99B1433067,99B1433068,99B1433069,99B1433070,99B1433071,99B1433072 99B1433073,99B1433074,99B1433075,99B1433076,99B1433080,99B1433081,99B1433082 99B1433084,99B1433086,99B1433109,99B1433122,99B1433141,99B1433142,99B1433143 99B1433144,99B1433145,99B1433146,99B1433147,99B1433148,99B1433149,99B1433150 99B1433151,99B1433152,99B1433153,99B1433154,99B1453305,99B1453306,99B1453307 99B1453308,99B1453309,99B1453310,99B1453311,99B1463315,99B1463316,99B1463317 99B1463318,99B1463319,99B1463320,99B1463321,99B1463322,99B1463323,99B1463324 99B1463325,99B1463326,99B1463342,99B1463343,99B1463344,99B1463345,99B1463346 99B1463347,99B1473348,99B1473349,99B1473350,99B1473351,99B1473352,99B1473353 99B1473368,99B1473386,99B1473387,99B1473388,99B1473390,99B1473392,99B1473393 99B1473394,99B1473395,99B1473396,99B1473397,99B1473398,99B1473401,99B1473402 99B1473407,99B1473408,99B1473409,99B1473410,99B1473415,99B1473416,99B1473417 99B1473418,99B1473419,99B1473420,99B1473421,99B1473422,99B1473423,99B1473424 99B1473425,99B1473434,99B1473435,99B1483450,99B1483451,99B1483452,99B1483500 99B1483501,99B1483502,99B1483503,99B1483556,99B1483557,99B1483558,99B1483559 99B1483560,99B1483561,99B1483562,99B1483563,99B1483564,99B1483565,99B1483566 99B1483567,99B1483568,99B1483569,99B1483570,99B1483571,99B1483572,99B1483573 99B1483574,99B1483575,99B1483576,99B1483577,99B1483578,99B1483579,99B1483580 99B1483581,99B1483582,99B1483583,99B1483584,99B1483585,99B1483586,99B1483587 99B1483588,99B1483589,99B1483590,99B1483608,99B1483609,99B1483610,99B1483611 99B1483612,99B1483613,99B1483614,99B1483615,99B1483616,99B1483617,99B1483618 99B1483623,99B1483624,99B1483625,99B1493626,99B1493652,99B1493745,99B1493746 99B1493747,99B1493748,99B1493749,99B1493750,99B1493751,99B1493752,99B1493753 99B1493754,99B1493755,99B1493756,99B1493757,99B1493758,99B1493759,99B1493760 99B14X3848,99B14X3849,99B14Y3856,99B14Y3857,99B14Y3867,99B14Y3964,99B14Y3965 99B14Y3966,99B14Y3967,99B14Y3986,99B14Y3999,99C14Z4000,99C14Z4001,99C14Z4002 99C14Z4003,99C14Z4004,99C14Z4023,99C14Z4024,99C14Z4025,99C14Z4026,99C14Z4027 99C14Z4028,99C14Z4029,99C14Z4030,99C14Z4046,99C14Z4047,99C14Z4066,99C14Z4067 99C14Z4068,99C14Z4069,99C14Z4070,99C14Z4071,99C14Z4072,99C14Z4073,99C14Z4097 99C14Z4098,99C14Z4099,99C14Z4116,99C14Z4118,99C14Z4119,99C14Z4120,99C14Z4121 99C14Z4124,99C14Z4125,99C14Z4126,99C14Z4127,99C14Z4128,99C14Z4129,99C14Z4130 99C14Z4131,99C1514132,99C1514133,99C1514134,99C1514135,99C1514136,99C1514137 99C1514138,99C1514139,99C1514140,99C1514141,99C1514142,99C1514143,99C1514152 99C1514153,99C1514154,99C1514155,99C1514156,99C1514162,99C1514173,99C1514174 99C1514175,99C1514176,99C1514177,99C1514178,99C1514179,99C1514180,99C1514181 99C1514182,99C1514183,99C1524192,99C1524193,99C1524197,99C1524198,99C1524199 99C1524224,99C1524225,99C1524226,99C1524227,99C1524296,99C1524297,99C1524298 99C1524311,99C1524312,99C1524313,99C1524314,99C1524315,99C1524316,99C1524317 99C1524318,99C1524319,99C1524320,99C1524321,99C1524322,99C1524323,99C1524324 99C1524325,99C1524326,99C1524327,99C1524358,99C1524359,99C1524360,99C1524361 99C1524362,99C1524363,99C1534391,99C1534392,99C1534393,99C1534394,99C1534395 99C1534396,99C1534397,99C1534398,99C1534399,99C1534400,99C1534401,99C1534402 99C1534403,99C1534404,99C1534405,99C1534406,99C1534407,99C1534410,99C1534411 99C1534412,99C1534413,99C1534414,99C1534421,99C1534453,99C1534454,99C1534455 99C1534456,99C1534457,99C1534461,99C1534462,99C1534463,99C1534464,99C1534465 99C1534466,99C1534467,99C1534468,99C1534469,99C1534470,99C1534471,99C1534472 99C1534473,99C1534474,99C1534475,99C1534476,99C1534477,99C1534478,99C1534479 99C1534480,99C1534481,99C1534482,99C1534483,99C1534485,99C1534486,99C1534487 99C1534488,99C1534489,99C1544548,99C1544549,99C1544550,99C1544551,99C1544552 99C1544553,99C1544579,99C1544580,99C1544581,99C1554613,99C1554614,99C1554615 99C1554616,99C1554622,99C1554623,99C1554624,99C1554625,99C1554626,99C1554627 99C1554628,99C1554629,99C1564692,99C1564693,99C1564694,99C1564719,99C1564720 99C1564721,99C1564722,99C1564723,99C1564724,99C1564725,99C1564744,99C1564745 99C1564746,99C1564747,99C1564771,99C1564772,99C1564773,99C1564774,99C1564775 99C1564776,99C1574777,99C1574778,99C1574802,99C1574803,99C1574850,99C1574851 99C1574852,99C1574853,99C1574870,99C1574871,99C1574872,99C1574873,99C1574874 99C1574875,99C1574876,99C1574878,99C1574879,99C1574880,99C1574881,99C1574882 99C1574883,99C1574884,99C1574885,99C1574886,99C1574887,99C1574888,99C1574889 99C1584957,99C1584958,99C1584986,99C1584987,99C1584988,99C1584999,99C1585000 99C1585016,99C1585017,99C1585018,99C1585019,99C1585020,99C1585021,99C1585022 99C1585023,99C1585024,99C1585025,99C1585026,99C1585027 (2)形式名 : TUS-X200S （261台） Ser. No : 99A1362001,99A1362002,99B1442004,99B1442005,99B1442006,99B1442007,99B1442008 99B1442009,99B1442010,99B1442011,99B1442012,99B1442013,99B1462014,99B1462015 99B1462016,99B1462017,99B1462018,99B1462019,99B1462020,99B1462021,99B1462022 99B1462023,99B1462024,99B1462025,99B1462026,99B1462027,99B1462028,99B1472029 99B1472030,99B1472031,99B1472032,99B1472033,99B1472034,99B1472035,99B1472036 99B1472037,99B1472038,99B1482039,99B1482040,99B1482041,99B1482042,99B1482043 99B1482044,99B1482045,99B1482046,99B1482047,99B1482048,99B1482049,99B1482050 99B1482051,99B1482052,99B1482053,99B1482054,99B1482055,99B1482056,99B1482057 99B1482058,99B1482059,99B1482060,99B1482061,99B1492062,99B1492063,99B1492064 99B1492065,99B1492066,99B1492067,99B1492068,99B1492069,99B1492070,99B1492071 99B1492072,99B1492073,99B1492074,99B1492075,99B1492076,99B1492077,99B1492078 99B1492079,99B1492080,99B1492081,99B1492082,99B1492083,99B1492084,99B1492085 99B1492086,99B1492087,99B1492088,99B1492089,99B1492090,99B1492091,99B1492092 99B14X2093,99B14X2094,99B14X2095,99B14X2096,99B14X2097,99B14X2098,99B14X2099 99B14Y2100,99B14Y2101,99B14Y2102,99B14Y2103,99C14Z2104,99C14Z2105,99C14Z2106 99C14Z2107,99C14Z2108,99C14Z2109,99C14Z2110,99C14Z2111,99C14Z2112,99C14Z2113 99C14Z2114,99C14Z2115,99C14Z2116,99C14Z2117,99C14Z2118,99C1512119,99C1512120 99C1512121,99C1512122,99C1512123,99C1512124,99C1512125,99C1512126,99C1512127 99C1512128,99C1512129,99C1512130,99C1512131,99C1512132,99C1512133,99C1522134 99C1522135,99C1522136,99C1522137,99C1522138,99C1522139,99C1522140,99C1522141 99C1522142,99C1522143,99C1522144,99C1522145,99C1522146,99C1522147,99C1522148 99C1522149,99C1522150,99C1522151,99C1522152,99C1522153,99C1522154,99C1522155 99C1522156,99C1522157,99C1522158,99C1532159,99C1532160,99C1532161,99C1532162 99C1532163,99C1532164,99C1532165,99C1532166,99C1532167,99C1532168,99C1532169 99C1532170,99C1532171,99C1532172,99C1532173,99C1532174,99C1532175,99C1532176 99C1532177,99C1532178,99C1542179,99C1542180,99C1542181,99C1542182,99C1542183 99C1542184,99C1542185,99C1542186,99C1542187,99C1542188,99C1542189,99C1542190 99C1542191,99C1542192,99C1542193,99C1542194,99C1542195,99C1542196,99C1542197 99C1542198,99C1542199,99C1542200,99C1542201,99C1552202,99C1552203,99C1552204 99C1552205,99C1552206,99C1552207,99C1552208,99C1552209,99C1552210,99C1552211 99C1552212,99C1562213,99C1562214,99C1562215,99C1562216,99C1562217,99C1562218 99C1562219,99C1562220,99C1562221,99C1562222,99C1562223,99C1562224,99C1562225 99C1562226,99C1572227,99C1572228,99C1572229,99C1572230,99C1572231,99C1572232 99C1572233,99C1572234,99C1572235,99C1572236,99C1572237,99C1572238,99C1572239 99C1572240,99C1572241,99C1572242,99C1572243,99C1582245,99C1582246,99C1582247 99C1582248,99C1582249,99C1582250,99C1582251,99C1582252,99C1582253,99C1582254 99C1582255,99C1582256,99C1582257,99C1582258,99C1582259,99C1582260,99C1582261 99C1582262,99C1582263 (3)形式名 : TUS-X100 （1626台） Ser. No : 99A13X2021,99A13X2022,99A13X2023,99A13X2024,99A13X2025,99A13X2026,99A13X2027 99A13X2028,99A13X2029,99A13X2030,99A13X2031,99A13X2032,99A13X2033,99A13X2034 99A13X2035,99A13X2036,99A13X2037,99A13X2038,99A13X2039,99A13X2040,99A13Y2041 99A13Y2042,99A13Y2043,99A13Y2044,99A13Y2045,99A13Y2046,99A13Y2051,99A13Y2052 99A13Y2061,99A13Y2062,99A13Y2063,99A13Y2064,99A13Y2065,99A13Y2066,99A13Y2067 99A13Y2068,99A13Y2069,99A13Y2070,99A13Y2071,99A13Y2072,99A13Y2081,99A13Y2082 99A13Y2083,99A13Y2084,99A13Y2085,99A13Y2086,99A13Y2087,99A13Y2088,99A13Y2089 99A13Y2090,99A13Y2091,99A13Y2092,99A13Y2093,99A13Y2094,99A13Y2095,99A13Z2096 99A13Z2097,99A13Z2098,99A13Z2099,99A13Z2100,99A13Z2101,99A13Z2102,99A13Z2103 99A13Z2104,99A1412105,99A1412106,99A1412107,99A1412108,99A1412109,99A1412110 99A1412111,99A1412112,99A1412147,99A1412148,99A1412149,99A1412150,99A1412164 99A1412165,99A1412166,99A1412167,99A1412168,99A1412169,99A1412170,99A1412171 99A1412172,99A1412173,99B1412177,99B1412178,99B1412179,99B1412180,99B1412181 99B1412197,99B1412198,99B1412199,99B1412200,99B1412201,99B1412202,99B1412203 99B1412204,99B1412205,99B1422206,99B1422207,99B1422208,99B1422209,99B1422210 99B1422211,99B1422221,99B1422222,99B1422223,99B1422224,99B1422225,99B1422226 99B1422227,99B1422228,99B1422229,99B1422230,99B1422235,99B1422236,99B1422237 99B1422238,99B1422241,99B1422242,99B1422243,99B1422244,99B1422245,99B1422246 99B1422247,99B1422248,99B1422249,99B1422250,99B1422251,99B1422252,99B1422253 99B1422254,99B1422255,99B1422256,99B1422257,99B1422258,99B1422259,99B1422260 99B1422266,99B1422267,99B1422268,99B1422269,99B1422270,99B1422271,99B1422272 99B1422273,99B1422274,99B1422275,99B1422276,99B1422277,99B1432278,99B1432279 99B1432280,99B1432281,99B1432282,99B1432283,99B1432284,99B1432285,99B1432286 99B1432287,99B1432288,99B1432289,99B1432290,99B1432291,99B1432292,99B1432293 99B1432294,99B1432295,99B1432296,99B1432297,99B1432298,99B1432299,99B1432300 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99C1574736,99C1574737,99C1574738,99C1574739,99C1574740,99C1574741,99C1574751 99C1574752,99C1574753,99C1574777,99C1574778,99C1574779,99C1574780,99C1574781 99C1574782,99C1574783,99C1574784,99C1574785,99C1574786,99C1574787,99C1574788 99C1574789,99C1574790,99C1574791,99C1574792,99C1574793,99C1574794,99C1574795 99C1574796,99C1574797,99C1574805,99C1574806,99C1574807,99C1574808,99C1574809 99C1574810,99C1574811,99C1574812,99C1574813,99C1574814,99C1574815,99C1574816 99C1574817,99C1574818,99C1574819,99C1574820,99C1574821,99C1574822,99C1574823 99C1574824,99C1574825,99C1574826,99C1574827,99C1574828,99C1574829,99C1574830 99C1574831,99C1574832,99C1574833,99C1574834,99C1574835,99C1584853,99C1584855 99C1584856,99C1584857,99C1584858,99C1584859,99C1584860,99C1584861,99C1584862 99C1584863,99C1584864,99C1584865,99C1584866,99C1584867,99C1584868,99C1584869 99C1584870,99C1584871,99C1584872,99C1584873,99C1584874,99C1584875,99C1584876 99C1584877,99C1584878,99C1584879,99C1584914,99C1584915,99C1584916,99C1584917 99C1584918,99C1584919,99C1584920,99C1584921,99C1584922,99C1584923,99C1584924 99C1584925,99C1584926,99C1584927,99C1584928,99C1584929,99C1584930,99C1584931 99C1584932,99C1584933,99C1584934,99C1584935,99C1584936,99C1584944,99C1584945 99C1584946,99C1584947,99C1584948,99C1584949,99C1584950,99C1584951,99C1584952 99C1584953,99C1584954,99C1584955,99C1584956,99C1584957,99C1584958,99C1584959 99C1584960,99C1584961,99C1584962,99C1584963,99C1584964,99C1584965,99C1584966 99C1584967,99C1584968,99C1584969,99C1584970,99C1584971,99C1584972,99C1584973 99C1584984,99C1584985,99C1584986,99C1584987,99C1584988,99C1584989,99C1584990 99C1584991,99C1584992,99C1584993,99C1584994,99C1584995,99C1584996,99C1584997 99C1584998,99C1584999,99C1585000,99C1585001,99C1585002,99C1585003,99C1585004 99C1585005,99C1585006,99C1585007,99C1585008,99C1585009,99C1585010,99C1585011 99C1585012,99C1585013,99C1585014,99C1585015,99C1585016,99C1585017,99C1585018 99C1585019,99C1585020 数量 ：2816 台 出荷時期 ：TUS-X200 初生産以降 平成 25年 5月 ～ 平成 27年 8月 TUS-X200S 初生産以降 平成 25年 6月 ～ 平成 27年 8月 TUS-X100 初生産以降 平成 25年 10月 ～ 平成 27年 8月
製造販売業者等名称
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
改修理由
当該超音波診断装置において、使用中にプローブコネクタの抜き差しや交換等を行った際に、エラーメッセージ が表示されることがありますが、継続して使用するとプローブ振動子面が熱くなり、長時間にわたり同一部位の 検査を行うと軽度の熱傷に至る可能性があることが判明しました。 このため、対策したソフトウェアのインストールを改修として実施します。
危惧される具体的な健康被害
本事象により、プローブ振動子面が熱くなるため、患者に熱傷の健康被害が発生することが考えられますが、長 時間継続して同一部位の検査を行うことはないため、重篤な健康被害が発生する可能性は無いと考えています。
改修開始年月日
平成28年6月9日 （情報提供の開始）
効能・効果又は用途等
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。
その他
納入しました医療機関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。
担当者及び連絡先
担当者 ： 佐々木 富也、北村 正彦 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