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平成23年 2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 ： ソノビスタ ＦＸ
対象ロット、数量及び出荷時期
(1)製造番号： 324278,324487,324279,324311,324615,324616,324927,324086,324289,324917,325064,324600,324617,324618 324984,324544,324712,324042,324793,324184,324365,324145,324265,324861,324068,324183,324840,324683 324684,324500,324181,324582,324044,324347,324348,324306,324207,324567,324843,324561,324416,324645 324660,324506,325050,324972,324386,324461,324193,324367,324065,324392,324309,324867,324868,324726 324566,324728,324030,324401,324633,324363,324657,324072,324070,324954,324869,324655,324794,324331 324384,324118,324058,324525,324678,324706,324551,324474,324874,324524,324139,324785,324399,324763 324218,324609,324967,324310,324813,324101,324290,324152,325034,324277,324914,324160,324855,324149 324177,324994,324221,324626,324032,324723,324097,325020,324588,324589,324682,324542,324543,324263 324656,324253,324661,324818,324817,324227,324420,324532,324125,324681,324129,324718,324251,324338 324842,324330,324773,324881,324601,324748,324247,324976,324151,324899,324834,324985,324671,324529 324699,324700,324004,324220,324553,325000,325006,324303,324352,324062,324953,324261,324232,325031 325032,325058,324403,324237,324133,324688,324961,324222,324862,324863,324767,324316,324317,324318 324319,324320,324447,324099,324355,324254,324255,324749,324854,324171,324897,324799,324189,324895 324896,324667,324674,324142,325029,324267,324482,324907,324528,324996,324017,324750,324664,324481 324668,324779,324197,324204,324262,324838,324839,324041,324830,324285,324885,324107,325022,324120 324770,324771,324381,324095,324315,324697,324538,324918,324919,324564,324800,324751,324894,324061 324977,324572,324570,324571,325061,324521,324446,324812,325044,325045,324211,324134,324056,324299 324293,324433,324174,324739,324721,324052,324391,324138,324737,324380,324388,324784,324011,324780 324410,324703,324273,325024,324132,324089,324458,324504,325054,324064,325016,325017,325060,324649 324257,324619,324191,325035,324281,324283,324240,325055,324533,324013,324490,324413,324423,324248 324604,324605,324606,324312,324175,325036,324209,324472,324910,324911,324286,324313,324314,324693 324913,324893,324764,324775,324037,324272,324781,324782,324412,324276,324786,324210,324722,324823 324889,324640,324687,324135,324467,324400,324876,324878,325049,324014,324093,324761,324762,324900 324836,324621,324569,324701,324702,324685,324717,324835,324341,325057,324883,324520,324406,324407 324408,324409,324832,324880,324024,324090,324978,324096,324991,324788,324789,324909,324323,324050 324049,324825,324745,324859,324948,324159,324172,324111,324143,324792,325009,324639,324828,324873 324223,324043,324045,324417,324507,324864,324865,324866,324586,324791,324100,324857,324015,324324 324292,324733,324212,325028,324969,324360,324361,324019,324298,324730,324238,324246,324491,324827 324870,324620,324847,324104,324694,324463,324890,324734,324067,324445,324665,324776,324241,324245 324250,324891,324892,324623,324105,324858,325018,324078,324398,324686,324822,324929,324456,324783 324964,324821,324358,324053,324741,324141,324581,324575,324161,325011,325008,324047,324483,324057 324731,324772,324322,324328,324777,324743,324719,324860,324680,324466,324239,324735,324288,324051 324778,324802,324115,324205,324021,324540,324199,324820,324574,324060,324302,324725,324959,324960 324902,324648,324459,324206,324334,324598,324599,325015,324887,324217,324430,324431,324432,324270 325043,324974,324906,324594,324455,324326,324271,324325,324982,324117,324562,324768,324573,324427 324583,324995,324236,324824,324769,324856,324201,324102,324585,324797,324523,324928,324636,324765 324549,324988,325062,325063,324349,325021,325014,324973,324987,325038,324597,324641,324216,324986 324811,324501,325037,324063,324296,324368,324952,324176,324707,324630,324249,324955,324350,324915 324428,324845,324846,324942,324632,324126,324173,324127,324871,324872,324059,325007,324038,324169 324214,324884,324801,324837,324144,324803,324695,324716,324039,324382,324614,324908,324094,324434 324022,324833,324608,324213,324727,324256,324814,324137,324148,324003,324028,324192,324713,324998 324710,324496,324304,324305,324644,324901,324048,324076,324554,324321,324121,324526,324968,324091 324997,324534,324975,324009,324724,325023,324489,324457,324663,324670,324087,324497,324166,324850 324448,324498,324509,324510,324511,324512,324513,324514,324515,324516,324517,324518,324519,324659 324027,324231,325056,324333,324499,324362,324819,324364,324808,324565,324669,324366,324295,324629 324415,324666,324522,324936,324202,324552,324387,324662,324389,324390,324103,324841,324005,324568 324844,325003,324106,324208,324738,324442,324746,324563,324300,324816,324336,324877,324266,324979 324268,324234,324242,324252,324965,324451,324692,324422,324109,324225,324580,324591,324882,324405 324119,324753,324747,325030,325013,324122,324983,324036,324454,324414,324084,324085,324215,324113 324035,325040,324098,324154,324116,324774,324642,324603,324443,324226,324752,324026,324203,324054 324112,324627,324421,324426,325027,324612,324168,324651,324613,324849,325012,324486,324075,324077 324999,324140,324488,324185,324228,324229,324092,324790,324479,324164,324345,324346,324460,324136 324182,324187,324186,324962,324123,324875,324679,324260,324354,324815,325052,324158,324736,324809 324677,324287,325019,324146,324150,324371,324375,324592,324593,324595,324631,324550,324646,324555 324888,324478,324012,324418,324545,324484,324165,324958,324031,324110,324826,324485,324852,324394 324178,324992,324244,324195,324993,324294,324402,324194,324596,324879,324503,324464,324198,324163 324577,324690,324578,324155,324576,324179,324625,324848,324372,324647,324676,324424,325065,325059 324190,324924,324925,324926,324536,324376,324180,324886,324638,324147,324798,324795,324071,324243 324635,324556,324938,324971,324922,324359,324732,324673,324444,324356,324766,324715,325026,324018 324624,324153,324537,324468,324921,324804,324607,324711,324083,324807,325025,324492,324493,324628 324188,324370,325041,325042,324653,324740,324916,324308,324233,324282,324558,324559,324652,324200 324034,324114,324634,324729,324920,324495,324329,325033,324219,324980,324584,324970,324429,324989 324425,324708,324340,324957,324351,324590,325002,324167,324494,324395,324541,324611,324343,324622 324259,324297,324658,325048,324280,324557,324269,324475,324476,324477,324742,324610,324258,324637 324704,324419,324373,324810,324831,324904,324327,324643,325051,324353,324411,324108,324851,324046 325039,324760,324654,324230,324755,324714,324805,324074,324291,324301,325001,324196,324435,324436 324157,324691,324530,324675,324705,324905,324480,324758,324759,324264,324903,324539,324709,324981 324378,324274,324990,324806,324337,324008,324016,324437,324438,324439,324440,324441,324449,324450 324452,324453,324130,324131,324698,325046,325047,324397,324335,324465,324224,324535,324796,324471 324088,324527,324404,324383,324235,324547,324912,324754,324546,324128,324505,324508,324307,324787 324956,324462,324284,324853,324040,324124,324531,324548,324829,324579,324689,324502,324720,324469 324470,325005,324963,325004,325010,324385,324756,324396,324023,324393 出荷台数：1004台 出荷時期：2009年1月から2010年12月
製造販売業者等名称
製造販売業者の名称 ： 持田シーメンスメディカルシステム株式会社 製造販売業者の所在地： 東京都品川区東五反田３丁目２０番１４号 高輪パークタワー 許可の種類 ： 第一種医療機器製造販売業 許可番号 ： 13B1X00191 製造所の名称：SIEMENS Ltd. Seoul 製造所の所在地：2〜3F, 370-5, Sanddaewon-Dong Chungwon-Gu Seongnam-si Gyeonggi-do, 462-807, Republic of Korea
改修理由
国内の納入先において、患者使用前の動作確認の水槽テストで、穿刺する範囲の目安である穿刺ガイドラインが 穿刺針とずれて表示されていることが確認されました。 製造元における調査の結果、穿刺ガイドラインを表示するためのソフトウェアの不具合であることが判明しまし た。 このため、対象となるソフトウェアを搭載した機器全数に対してソフトウェアの修正を実施させていただきま す。
危惧される具体的な健康被害
一般的に穿刺針の位置を超音波画像で確認しながら穿刺針を進めるため、穿刺針の先端が穿刺ガイドラインと一 致しなかった場合には、術者は容易に異常に気づくことができます。したがって重篤な健康被害が発生すること はないと考えます。 なお、今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。
改修開始年月日
平成23年2月09日 情報提供の開始
効能・効果又は用途等
超音波を用いて体内の形状、性状又は動態を可視化し、画像情報を診断のために提供します。
その他
納入しました医療機関はすべて特定しており、対象機器に対して改善済のソフトウエアをインストールする改修 を実施致します。
担当者及び連絡先
担当者 ： 安全管理責任者 山崎 文義 品質保証責任者 前田 誠 連絡先 ： 持田シーメンスメディカルシステム株式会社 ＣＳ部 電話番号： 03-5423-8700 FAX番号 ： 03-5423-8511