| 閉じる |
平成27年10月23日作成
一般名及び販売名
一般的名称： 据置型デジタル式汎用X線透視診断装置 販売名 ： (1)デジタルX線TVシステム ZEXIRA DREX-ZX80 (2)多目的デジタルＸ線ＴＶシステム Ultimax-i DREX-UI80
対象ロット、数量及び出荷時期
(1)形式名 : DREX-ZX80 SerNo. : G1A1012002,G1A1012003,G1A1072004,G1A1112005,G1B11Z2006,G2A0982001,G2A0992002 G2A0992003,G2A09X2004,G2A09Y2005,G2A09Y2006,G2A09Z2007,G2A1022008,G2A1032009 G2A1032010,G2A1042011,G2A1052012,G2A1052013,G2A1092014,G2A1092015,G2A10X2016 G2A10Z2017,G2A10Z2018,G2A10Z2019,G2B1172020,G2B11X2021,G2B11X2022,G2C12Y2023 G2C1342024,G2D1422025,G2D1462026,P1A08Z2001,P1A08Z2002,P1A0922003,P1A0922004 P1A0932005,P1A0942006,P1A0952007,P1B0992008,P1B0992009,P1B0992010,P1B09Y2011 P1B09Y2012,P1B09Y2013,P1B09Z2014,P1B09Z2015,P1B09Z2016,P1B1012017,P1B1022018 P1B1022019,P1B1022020,P1B1022021,P1B1022022,P1B1032023,P1B1032024,P1B1032025 P1B1032026,P1B1042027,P1B1042028,P1B1042029,P1B1042030,P1B1072031,P1B1072032 P1B1072033,P1B1082034,P1B1082035,P1B1082036,P1B1082037,P1B1082038,P1B1082039 P1B1092040,P1B1092041,P1B1092042,P1B1092043,P1B10X2044,P1B10Y2045,P1B10Y2046 P1B10Z2047,P1B10Z2048,P1B10Z2049,P1B1112050,P1B1112051,P1B1112052,P1B1112053 P1B1112054,P1B1112055,P1B1112056,P1C1122057,P1C1122058,P1C1122059,P1C1132060 P1C1132061,P1C1142062,P1C1142063,P1C1142064,P1C1152065,P1C1162066,P1C1182067 P1C1192068,P1C11X2069,P1C11X2070,P1C11Z2071,P1C1212072,P1D1222073,P1D1232074 P1D1232075,P1D1232076,P1D1232077,P1D1232078,P1D1242079,P1D1242080,P1D1242081 P1D1242082,P1D1242083,P1D1252084,P1D1252085,P1D1252086,P1D1252087,P1D1262088 P1D1262089,P1D1272090,P1D1272091,P1D1272092,P1D1272093,P1D1282094,P1D1282095 P1D1282096,P1D1292097,P1D1292098,P1D1292099,P1D12X2100,P1D12Y2101,P1D12Y2102 P1D12Y2103,P1D12Z2104,P1D12Z2105,P1D12Z2106,P1D1312107,P1D1312108,P1D1312109 P1D1322110,P1D1322111,P1D1322112,P1D1322113,P1D1322114,P1D1332115,P1D1332116 P1D1332117,P1D1332118,P1D1332119,P1D1342120,P1D1342121,P1D1352122,P1D1362123 P1D1362124,P1E1392125,P1E1392126,P1E1392127,P1E13X2128,P1E13X2129,P1E1412130 P1E1422131,P1E1422132,P1E1422133,P1E1422134,P1E1432135,P1E1432136,P1E1432137 P1E1492138,P1F14X2139,P1F1512140,P1F1512141,P1F1522142,P1F1522143,P1F1522144 P1F1532145,P1F1562146,P2A08X2001,P2A08Y2002,P2A08Y2003,P2A08Y2004,P2A08Y2005 P2A0912006,P2A0912007,P2A0922008,P2A0922009,P2A0932010,P2A0932011,P2A0932012 P2A0932013,P2A0942014,P2A0942015,P2A0942016,P2A0942017,P2B0972018,P2B0972019 P2B0972020,P2B0982021,P2B0982022,P2B0982023,P2B0982024,P2B0982025,P2B0992026 P2B0992027,P2B0992028,P2B0992029,P2B0992030,P2B0992031,P2B0992032,P2B0992033 P2B0992034,P2B0992035,P2B09X2036,P2B09X2037,P2B09X2038,P2B09Y2039,P2B09Y2040 P2B09Y2041,P2B09Y2042,P2B09Y2043,P2B09Y2044,P2B09Z2045,P2B09Z2046,P2B09Z2047 P2B1012048,P2B1012049,P2B1012050,P2B1012051,P2B1012052,P2B1012053,P2B1012054 P2B1012055,P2B1012056,P2B1012057,P2B1012058,P2B1012059,P2B1022060,P2B1022061 P2B1022062,P2B1022063,P2B1022064,P2B1022065,P2B1022066,P2B1022067,P2B1032068 P2B1032069,P2B1032070,P2B1032071,P2B1032072,P2B1032073,P2B1032074,P2B1042075 P2B1042076,P2B1042077,P2B1052078,P2B1052079,P2B1052080,P2B1052081,P2B1052082 P2B1062083,P2B1062084,P2B1072085,P2B1072086,P2B1072087,P2B1072088,P2B1072089 P2B1082090,P2B1082091,P2B1082092,P2B1082093,P2B1092094,P2B1092095,P2B1092096 P2B10X2097,P2B10X2098,P2B10Y2099,P2B10Y2100,P2B10Z2101,P2B10Z2102,P2B10Z2103 P2B1112104,P2B1112105,P2B1112106,P2B1112107,P2B1112108,P2C1122109,P2C1122110 P2C1122111,P2C1122112,P2C1122113,P2C1122114,P2C1122115,P2C1122116,P2C1122117 P2C1122118,P2C1132119,P2C1132120,P2C1142121,P2C1142122,P2C1142123,P2C1152124 P2C1152125,P2C1152126,P2C1152127,P2C1162128,P2C1162129,P2C1162130,P2C1162131 P2C1162132,P2C1172133,P2C1172134,P2C1182135,P2C1182136,P2C1182137,P2C1182138 P2C1192139,P2C1192140,P2C1192141,P2C1192142,P2C1192143,P2C1192144,P2C1192145 P2C11X2146,P2C11X2147,P2C11Y2148,P2C11Y2149,P2C11Y2150,P2C11Y2151,P2C11Y2152 P2C11Y2153,P2C11Y2154,P2C11Z2155,P2C11Z2156,P2C11Z2157,P2C11Z2158,P2C1212159 P2C1212160,P2C1212161,P2C1212162,P2C1212163,P2C1212164,P2C1212165,P2D1222166 P2D1222167,P2D1222168,P2D1222169,P2D1222170,P2D1222171,P2D1222172,P2D1222173 P2D1222174,P2D1222175,P2D1232176,P2D1232177,P2D1232178,P2D1232179,P2D1232180 P2D1232181,P2D1232182,P2D1242183,P2D1242184,P2D1242185,P2D1242186,P2D1242187 P2D1252188,P2D1262189,P2D1262190,P2D1272191,P2D1272192,P2D1272193,P2D1272194 P2D1272195,P2D1272196,P2D1282197,P2D1282198,P2D1282199,P2D1282200,P2D1282201 P2D1282202,P2D1282203,P2D1292204,P2D1292205,P2D1292206,P2D1292207,P2D1292208 P2D1292209,P2D12X2210,P2D12X2211,P2D12X2212,P2D12Y2213,P2D12Y2214,P2D12Y2215 P2D12Y2216,P2D12Z2217,P2D12Z2218,P2D12Z2219,P2D12Z2220,P2D12Z2221,P2D1312222 P2D1312223,P2D1312224,P2D1312225,P2D1312226,P2D1312227,P2D1312228,P2D1312229 P2D1322230,P2D1322231,P2D1322232,P2D1322233,P2D1322234,P2D1322235,P2D1322236 P2D1322237,P2D1322238,P2D1322239,P2D1322240,P2D1332241,P2D1332242,P2D1332243 P2D1332244,P2D1332245,P2D1332246,P2D1332247,P2D1332248,P2D1332249,P2D1332250 P2D1332251,P2D1332252,P2D1342253,P2D1342254,P2D1342255,P2D1342256,P2D1342257 P2D1342258,P2D1342259,P2D1342260,P2D1342261,P2D1342262,P2D1352263,P2D1362264 P2E1372265,P2E1372266,P2E1372267,P2E1372268,P2E1382269,P2E1382270,P2E1392271 P2E1392272,P2E1392273,P2E1392274,P2E1392275,P2E1392276,P2E1392277,P2E1392278 P2E1392279,P2E1392280,P2E13X2281,P2E13X2282,P2E13X2283,P2E13Y2284,P2E13Y2285 P2E13Y2286,P2E13Z2287,P2E13Z2288,P2E13Z2289,P2E13Z2290,P2E13Z2291,P2E1412292 P2E1412293,P2E1412294,P2E1412295,P2E1412296,P2E1422297,P2E1422298,P2E1422299 P2E1422300,P2E1422301,P2E1422302,P2E1422303,P2E1422304,P2E1432305,P2E1432306 P2E1432307,P2E1432308,P2E1432309,P2E1442310,P2E1462311,P2E1462312,P2E1462313 P2E1462314,P2E1472315,P2E1472316,P2E1482317,P2E1482318,P2E1492319,P2E1492320 P2E1492321,P2E1492322,P2E1492323,P2E1492324,P2F14X2325,P2F14X2326,P2F14X2327 P2F14X2328,P2F14X2329,P2F14Y2330,P2F14Z2332,P2F14Z2333,P2F14Z2334,P2F14Z2335 P2F1512336,P2F1512337,P2F1512338,P2F1512339,P2F1512340,P2F1522341,P2F1522342 P2F1522343,P2F1522344,P2F1532345,P2F1532346,P2F1532347,P2F1542348,P2F1542349 P2F1542350,P2F1542351,P2F1552352,P2F1552353,P2F1562354,P2F1572355,P3A0942001 P3A0942002,P3B09Y2003,P3B1012004,P3B1032005,P3B10Z2006,P3C1132007,P3D12Z2008 P3D1312009,P3E1452010,P3E1462011,P3F1512012,P4A08Z2001,P4B09Z2003,P4C1122004 S1A0992001,S1A0992002,S1A09X2003,S1A09X2004,S1A09Y2005,S1A09Y2006,S1A09Z2007 S1A1012009,S1A1012010,S1A1022011,S1A1022012,S1A1022013,S1A1022014,S1A1032015 S1A1042017,S1A1042018,S1A1042019,S1A1042020,S1A1052021,S1A1052022,S1A1062023 S1A1062024,S1A1062025,S1A1072026,S1A1072027,S1A1072028,S1A1082029,S1A1082030 S1A1092031,S1A1092032,S1A1092033,S1A1092034,S1A10Z2035,S1A10Z2036,S1A10Z2037 S1A1112038,S1A1112039,S1A1382075,S1A1382076,S1B1142040,S1B1162041,S1B1162042 S1B1162043,S1B1172044,S1B1172045,S1B1172046,S1B1182047,S1B1192048,S1B1192049 S1B11X2050,S1B11X2051,S1B11X2052,S1B11X2053,S1B11X2054,S1B11X2055,S1B11X2056 S1B11X2057,S1B11Y2058,S1B11Y2059,S1B11Y2060,S1B11Z2061,S1B11Z2062,S1B11Z2063 S1C1222064,S1C1222065,S1C1272066,S1C1272067,S1C12Z2068,S1C1312069,S1C1342070 S1C1362071,S1C1372072,S1C1372073,S1C1382074,S1C1392077,S1C13Z2078,S1C1422079 S1C1422080,S1C1422081,S1C1432082,S1C1462083,S1C1482084,S1C1492085,S1D1522086 S1D1542087,S1D1572088,S2A08Z2001,S2A0912002,S2A0912003,S2A0912004,S2A0972005 S2A0992006,S2A0992007,S2A0992008,S2A0992009,S2A0992010,S2A0992011,S2A0992012 S2A09X2013,S2A09X2014,S2A09X2015,S2A09Y2016,S2A09Y2017,S2A09Y2018,S2A09Y2019 S2A09Y2020,S2A09Y2021,S2A09Y2022,S2A09Y2023,S2A09Y2024,S2A09Z2025,S2A09Z2026 S2A09Z2027,S2A1012028,S2A1012029,S2A1012030,S2A1012031,S2A1012032,S2A1022033 S2A1022034,S2A1022035,S2A1022036,S2A1022037,S2A1032038,S2A1032039,S2A1032040 S2A1032041,S2A1032042,S2A1032043,S2A1032044,S2A1032045,S2A1042046,S2A1042047 S2A1052048,S2A1052049,S2A1052050,S2A1052051,S2A1062052,S2A1062053,S2A1062054 S2A1062055,S2A1072056,S2A1072057,S2A1072058,S2A1072059,S2A1072060,S2A1072061 S2A1082062,S2A1082063,S2A1082064,S2A1082065,S2A1082066,S2A1082067,S2A1082068 S2A1092069,S2A1092070,S2A1092071,S2A10X2072,S2A10X2073,S2A10Y2074,S2A10Y2075 S2A10Z2076,S2A10Z2077,S2A10Z2078,S2A10Z2079,S2A1112080,S2A1112081,S2A1112082 S2A1272134,S2B1122083,S2B1122084,S2B1122085,S2B1122086,S2B1122087,S2B1132088 S2B1132089,S2B1132090,S2B1132091,S2B1132092,S2B1132093,S2B1152094,S2B1152095 S2B1152096,S2B1152097,S2B1162098,S2B1162099,S2B1162100,S2B1172101,S2B1182102 S2B1182103,S2B1182104,S2B1182105,S2B1182106,S2B1182107,S2B1192108,S2B1192109 S2B11X2110,S2B11Y2111,S2B11Z2112,S2B11Z2113,S2B11Z2114,S2B1212115,S2B1212116 S2B1212117,S2B1212118,S2B1212119,S2C1222120,S2C1222121,S2C1222122,S2C1222123 S2C1222124,S2C1232125,S2C1232126,S2C1232127,S2C1232128,S2C1242129,S2C1242130 S2C1252131,S2C1272132,S2C1272133,S2C1272135,S2C1272136,S2C1272137,S2C1282138 S2C1292139,S2C1292140,S2C1292141,S2C1292142,S2C1292143,S2C12X2144,S2C12X2145 S2C12Y2146,S2C12Y2147,S2C12Z2148,S2C12Z2149,S2C12Z2150,S2C1312151,S2C1312152 S2C1312153,S2C1322154,S2C1322155,S2C1332156,S2C1332157,S2C1342158,S2C1352159 S2C1372160,S2C1382161,S2C1382162,S2C1392163,S2C13Y2164,S2C13Z2165,S2C1412166 S2C1422167,S2C1422168,S2C1432169,S2C1442170,S2C1452171,S2C1482172,S2D14X2173 S2D14Z2174,S2D14Z2175,S2D1512176,S2D1512177,S2D1522178,S2D1532179,S2D1542180 S2D1552181,SZA1092001 数量 : 814台 出荷時期 : 平成 20年 10月〜平成 27年 7月 (2)形式名 : DREX-UI80 SerNo. : 01A0932001,01A0932002,01A0932003,01A0932004,01A0942006,01A0942007,01A0942008 02A0942001,02A0962002,02A0962003,02A0972004,02A0982005,02A0992006,02A0992007 02A09X2008,02A09Y2009,02A09Z2010,02A09Z2011,02A1012012,02A1022013,02A1022014 02A1022015,02A1032016,02A1032017,02A1032018,02A1032019,02A1042020,02A1052021 02A1062022,02A1072023,02A1072024,02A1082025,02A10Y2026,02A10Y2027,02A10Z2028 02A1112029,02A1122030,02A1122031,02A1122032,02A1132033,02A1142034,02A1142035 02A1142036,02A1152037,02A1162038,02A1182039,02A1192040,02A11X2041,02A11X2042 02A11X2043,02A11Y2044,02B11Y2045,02B11Z2046,02B11Z2047,02B1212048,02B1212049 02C1222050,02C1232051,02C1232052,02C1232053,02C1232054,02C1232055,02C1272056 02C1272057,02C1272058,02C1272059,02C1272060,02C1282061,02C1282062,02C1282063 02C12X2064,02C12X2065,02C12Y2066,02C12Y2067,02C12Y2068,02C12Y2069,02C12Z2070 02C12Z2071,02C1312072,02C1312073,02C1322074,02C1322075,02C1322076,02C1322077 02C1322078,02C1332079,02C1332080,02C1332081,02C1332082,02C1332083,02C1332084 02C1332085,02D1352086,02D1352087,02E1372088,02E1382089,02E1382090,02E1392091 02E1392092,02E1392093,02E13X2094,02E13X2095,02E13Y2096,02E13Y2097,02E13Z2098 02E13Z2099,02E13Z2100,02E1412101,02E1412102,02E1422103,02E1422104,02E1422105 02E1422106,02E1422107,02E1422108,02E1432109,02E1432110,02E1432111,02E1432112 02E1432113,02E1442114,02E1452115,02E1452116,02E1472117,02E1482118,02E1492120 02E1492121,02E1492122,02F14X2123,02F14X2124,02F14Z2125,02F14Z2126,02F14Z2127 02F14Z2128,02F1512129,02F1512130,02F1512131,02F1522132,02F1522133,02F1532134 02F1532135,02F1532136,02F1532137,02F1532138,02F1562139,03A10Z2001,03A1192002 03B1212003,03C1222004,03C1262005,03C1312006,03C1332007,03C1332008,03C1342009 03E1372010,03E13Z2011,03E13Z2012,03E1412013,03E1462014,03E1462015,03E1462016 03E1472017,03E1482018,03F14X2019,03F14Y2020,03F14Z2021,03F1512022,03F1522023 03F1532024,03F1532025,04C12Z2001,05A0982001,05A0982002,05A0992003,05A0992004 05A0992005,05A09Y2006,05A1012007,05A1012008,05A1012009,05A1022010,05A1022011 05A1022012,05A1022013,05A1032014,05A1032016,05A1032017,05A1032018,05A1032019 05A1032020,05A1062022,05A1072023,05A1082024,05A1092025,05A1092026,05A10X2027 05A10Y2028,05A10Y2029,05A10Z2030,05A1112031,05A1112032,05A1122033,05A1122034 05A1122035,05A1122036,05A1132037,05A1132038,05A1132039,05A1132040,05A1132041 05A1142042,05A1162043,05A1182044,05A1182045,05A1192046,05A1192047,05B11Y2048 05B1212049,05C1222050,05C1222051,05C1232052,05C1232053,05C1232054,05C1242055 05C1252056,05C1262057,05C1282058,05C1282059,05C1292060,05C12Y2061,05C12Y2062 05C12Y2063,05C1332064,05C1332065,05C1332066,05E13Y2067,05E13Y2068,05E13Y2069 05E13Z2070,05E13Z2071,05E1422072,05E1432073,05E1482074,05E1492075,05F14Z2076 05F1512077,05F1512078,05F1522079,05F1522080,05F1532081,05F1542082,05F1562083 11A1172001,11B11Y2002,12A09Y2001,12A1032002,12A1132003,12A1142004,12A1172005 12B1212006,12C1222007,12D13Z2008,12D1472009,12D1472010 数量 : 264台 出荷時期 : 平成 21年 3月〜平成 27年 6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
検査中、ライブモニタに撮影画像が正常に表示されているにもかかわらず、ソフトウェアの問題により、 ハードディスクに撮影画像が正しく保存されない場合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、再撮影による不要被ばくが考えられますが、その線量は通常のX線検査で照射される程度であ り、重篤な健康被害が発生する可能性はないと考えています。 なお、これまでに本事象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27年10月23日 （情報提供の開始）
効能・効果又は用途等
Ｘ線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、医師もしくは診療放射線技師等有資格者 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、全対象装置への対策を改修として実施します。
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