閉じる 
    平成20年10月17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)全身用X線CT装置 HiSpeed
             (2)全身用X線CT装置 ProSpeed
             (3)全身用X線CT装置 CT ProSpeed

  2. 対象ロット、数量及び出荷時期

    3. 製造番号  ：
（1）全身用X線CT装置 HiSpeed
DM0001、DM0002、DM0007、DM0008、DX0136、DX0137、DX0138、DX0139、DX0143、DX0144、DX0146、
DX0147、DX0148、DX0151、DX0152、DX0154、DX0155、DX0156、DX0158、DX0159、DX0160、DX0161、
DX0163、DX0164、DX0165、DX0166、DX0167、DX0168、DX0169、DX0170、DX0171、DX0173、DX0175、
DX0177、DX0180、DX0181、DX0182、DX0183、DX0186、DX0187、DX0189、DX0190、DX0191、DX0192、
DX0193、DX0194、DX0195、DX0196、DX0197、DX0198、DX0199、DX0200、DX0201、DX0202、DX0204、
DX0206、DX0208、DX0209、DX0210、DX0212、DX0213、DX0214、DX1216、DX1217、DX1218、DX1219、
DX1220、DX1221、DX1222、DX1223、DX1224、DX1226、DX1227、DX1228、DX1229、DX1230、DX1231、
DX1233、DX1235、DX1236、DX1239、DX1240、DX1241、DX1242、DX1243、DX1244、DX1245、DX1247、
DX1248、DX1249、DX1251、DX1252、DX1253、DX1254、DX1255、DX1256、DX1257、DX1258、DX1259、
DX1261、DX2262、DX2263、DX2264、DX2265、DX2266、DX2267、DX2268、DX2269、DX2270、DX2271、
DX2272、DX2273、DX2282、DX4286、DX8002、DX8004、DX8005、DX8007、DX8009、DX8013、DX8016、
DX8020、DX8021、DX8022、DX8023、DX8026、DX8029、DX8032、DX8033、DX8035、DX8036、DX8037、
DX8038、DX8039、DX8040、DX9044、DX9045、DX9046、DX9047、DX9048、DX9049、DX9051、DX9052、
DX9054、DX9057、DX9058、DX9059、DX9060、DX9061、DX9062、DX9065、DX9066、DX9067、DX9068、
DX9074、DX9076、DX9077、DX9078、DX9079、DX9080、DX9083、DX9084、DX9085、DX9086、DX9087、
DX9088、DX9089、DX9093、DX9094、DX9097、DX9099、DX9100、DX9103、DX9104、DX9105、DX9106、
DX9107、DX9108、DX9110、DX9111、DX9112、DX9113、DX9114、DX9115、DX9116、DX9119、DX9120、
DX9122、DX9123、DX9124、DX9125、DX9126、DX9127、DX9130、DX9133、DX9134、DX9135、FX0073、
FX0075、FX0077、FX0078、FX0080、FX0081、FX0083、FX0086、FX0087、FX0091、FX0092、FX0093、
FX0094、FX0095、FX0097、FX0099、FX0101、FX8001、FX8002、FX8003、FX8004、FX8005、FX8007、
FX8009、FX8010、FX8011、FX8013、FX8016、FX8018、FX8019、FX8020、FX8022、FX8025、FX9031、
FX9036、FX9038、FX9039、FX9041、FX9046、FX9047、FX9048、FX9049、FX9051、FX9053、FX9057、
FX9058、FX9059、FX9061、FX9062、FX9064、FX9065、FX9067、LX0038、LX0039、LX8001、LX8002、
LX8004、LX8009、LX8010、LX8011、LX8012、LX8016、LX8017、LX8019、LX8020、LX8021、LX9024、
LX9031、LX9032、NP0002、NP0004、NP0005、NP0006、NP0007、NP0008、NP0009、NP0010、NP1011、
NX0002、NX0003、NX0004、NX0006、NX0008、NX0009、NX0010、NX0011、NX0012、NX0015、NX0016、
NX0018、NX0021、NX0022、NX0023、NX0025、NX0028、NX0029、NX0030、NX0031、NX0032、NX0033、
NX0034、NX0035、NX1036、NX1037、NX1038、NX1040、NX1041、NX1042、NX1044、NX1045、NX1046、
NX1047、NX1048、NX1049、NX1050、NX1051、NX1052、NX1053、NX1054、NX1056、NX1058、NX1059、
NX1061、NX1063、NX1064、NX1065、NX1067、NX1068、NX1070、NX1071、NX1072、NX1073、NX1075、
NX1076、NX1077、NX1079、NX1080、NX1081、NX1082、NX1084、NX1085、NX2087、NX2088、NX2089、
NX2090、NX2091、NX2093、NX2094、NX2096、NX2097、NX2098、NX2099、NX2100、NX2103、NX2104、
NX2105、NX2107、NX2108、NX2109、NX2110、NX2111、NX2112、NX2113、NX2114、NX2115、NX3116、
NX3117、NX3118、NX3120、NX3121、NX3122、NX3123、NX3124、NX3125、NX3126、NX3127、NX3128、
NX3130、NX3131、NX3132、NX3133、NX3135、NX4136、NX4137、NX4138、NX4140、NX4141、NX4144、
NX4150、SX2001、SX2002、SX2003、SX2004、SX2005、SX2006、SX2007、SX2008、SX2009、SX2010、
SX2011、SX2012、SX2020、XF0001、XF0002、XF0003、XF0004、XF0005、XF0006、XF0007、XF0008、
XF0009、XF0015、XF0016、XF0017、XF0019、XF0020、YX1039、YX1044、YX1049、YX1052、YX1057、
ZX0003、ZX0005、ZX0006、ZX0007、ZX0008、ZX0010、ZX0011、ZX0014、ZX0015、ZX0016、ZX9002、
４２９台

（2）全身用X線CT装置 ProSpeed
RF0007、RF0008、RF0009、RF0011、RF0012、RF0014、RF0015、RF0016、RF0017、RF0018、RF0019、
RF0020、RF0021、RF0022、RF0024、RF0025、RF0026、RF0027、RF0028、RF0029、RF0031、RF0036、
RF0037、RF0038、RF0039、RF0041、RF0042、RF0043、RF0044、RF0045、RF0046、RF0048、RF0050、
RF0051、RF0053、RF0054、RF0055、RF0056、RF0058、RF0059、RF0061、RF0062、RF0063、RF0066、
RF0068、RF0069、RF0070、RF0071、RF0072、RF0073、RF0074、RF0075、RF0076、RF0077、RF0078、
RF0080、RF0081、RF0082、RF0083、RF0084、RF0085、RF0086、RF0087、RF0088、RF0089、RF0090、
RF0092、RF0093、RF0094、RF0097、RF0098、RF0099、RF0100、RF1101、RF1102、RF1104、RF1105、
RF1106、RF1107、RF1108、RF1109、RF1110、RF1111、RF1112、RF1113、RF1115、RF1116、RF1117、
RF1118、RF1119、RF1120、RF1121、RF1123、RF1124、RF1125、RF1126、RF1127、RF1129、RF1130、
RF1131、RF1132、RF1133、RF1134、RF1135、RF1136、RF1138、RF1139、RF1140、RF1141、RF1142、
RF1143、RF1144、RF1145、RF1146、RF1147、RF1148、RF1149、RF1150、RF1151、RF1154、RF1155、
RF2156、RF2157、RF2158、RF2159、RF2160、RF2161、RF2162、RF2163、RF2164、RF2165、RF2166、
RF2167、RF2168、RF2169、RF2170、RF2173、RF2174、RF2175、RF2176、RF2177、RF2178、RF2179、
RF2180、RF2181、RF2182、RF2183、RF2185、RF2186、RF2187、RF2188、RF2189、RF2190、RF2191、
RF3192、RF3193、RF3194、RF3195、RF3196、RF3197、RF3198、RF3199、RF3200、RF3201、RF3202、
RF3203、RF3204、RF3205、RF3206、RF3207、RF3208、RF3209、RF3210、RF3211、RF3212、RF3213、
RF3214、RF3215、RF9001、RF9004、RH2001、RH2002、RH2003、RH2004、RH2006、RH2007、RH2008、
RH2009、RH2010、RH2011、RH2012、RH2013、RH2014、RH2015、RH2016、RH2017、RH2019、RH2020、
RH2021、RH2022、RH2023、RH2024、RH2025、RH2026、RH2027、RH2028、RH2029、RH2030、RH2031、
RH2032、RH2033、RH2034、RH2035、RH2037、RH2038、RH2039、RH2040、RH2041、RH3042、RH3043、
RH3044、RH3045、RH3046、RH3047、RH3048、RH3049、RH3050、RH3051、RH3052、RH3053、RH3054、
RH3055、RH3056、RH3057、RH3058、RH3059、RH3060、RH3061、RH3062、RH3063、RH3066、RH3067、
RH3068、RH3069、RH3070、RH3072、RH3073、RH3074、RH3075、RH3076、RH3077、RH3078、RH3079、
RH3080、RH3081、RH3082、RH3083、RH3084、RH4085、RH4086、RH4087、RH4088、RH4089、RH4090、
RH4091、RH4092、RH4093、RH4094、RH4095、RH4096、RH4097、RH4098、RH4099、RH4100、RH4101、
RH4102、RH4103、RH4104、RH4105、RH4106、RH4107、RH4108、RH4110、RH4111、RH4112、RH4113、
RH4114、RH4115、RH4116、RH4117、RH4118、RH4120、RH4121、RH4122、RH4123、RH4124、RH4125、
RH4126、RH4127、RH4128、RH4129、RH4130、RH4131、RH4132、RH4134、RH4135、RH4136、RH4137、
RH4138、RH4139、RH4140、RH4141、RH4142、RH4143、RH4144、RH4145、RH4146、RH4148、RH4149、
RH4150、RH4151、RH4152、RH4153、RH4154、RH4156、RH4157、RH4158、RH4159、RH4160、RH4161、
RH4162、RH4163、RH4164、RH4165、RH4166、RH4167、RH4168、RH4169、RH4170、RH4171、RH4172、
RH4173、RH4174、RH4175、RH4176、RH4177、RH4178、RH4179、RH4180、RH4181、RH4182、RH4183、
RH4184、RH5186、RH5187、RH5188、RH5189、RH5190、RH5191、RH5192、RH5193、RH5194、RH5195、
RH5196、RH5197、RH5198、RH5199、RH5200、RH5201、RH5202、RH5203、RH5204、RH5205、RH5206、
RH5207、RH5208、RH5209、RH5210、RH5211、RH5212、RH5213、RH5214、RH5215、RH5216、RH5217、
RH5218、RH5219、RH5220、RH5221、RH5222、RH5223、RH5224、RH5225、RH5226、RH5227、RH5228、
RH5229、RH5230、RH5231、RH5232、RH5233、RH5234、RH5235、RH5236、RH5237、RH5238、RH5239、
RH5240、RH5241、RH5242、RH5243、RH5244、RH5245、RH5246、RH5247、RH5248、RH5249、RH5250、
RH5251、RH5252、RH5253、RH5254、RH5255、RH5256、RH5257、RH5258、RH5259、RH5260、RH5261、
RH5262、RH5263、RH5264、RH5266、RH5267、RH5268、RH5269、RH5270、RH5271、RH5272、RH5274、
RH5275、RH5276、RH5277、RH5279、RH5280、RH5281、RH5283、RX0002、RX0003、RX0004、RX0005、
RX0006、RX0007、RX0008、RX0009、RX0010、RX0011、RX0012、RX0013、RX0015、RX0016、RX0017、
RX0019、RX0020、RX0021、RX0022、RX0023、RX0024、RX0025、RX0026、RX0027、RX0029、RX0030、
RX1031、RX1032、RX1033、RX1034、RX1035、RX1037、RX1038、RX1039、RX1040、RX1041、RX1042、
RX1043、RX1044、RX1046、RX1047、RX1048、RX1050、RX1051、RX1052、RX1054、RX1055、RX1056、
RX1058、RX1060、RX1061、RX1062、RX1064、RX1065、RX1066、RX1067、RX1068、RX1069、RX1070、
RX1071、RX1072、RX1073、RX1075、RX1076、RX1077、RX1078、RX1079、RX1080、RX1081、RX1082、
RX1083、RX1085、RX1086、RX1087、RX1090、RX1091、RX1092、RX1095、RX1096、RX1098、RX1099、
RX1100、RX1101、RX1102、RX1103、RX1104、RX1105、RX1106、RX1107、RX2110、RX2111、RX2112、
RX2113、RX2114、RX2116、RX2117、RX2118、RX2119、RX2120、RX2123、RX2124、RX2125、RX2126、
RX2127、RX2128、RX2129、RX2130、RX2131、RX2132、RX2133、RX2134、RX2135、RX2136、RX2137、
RX2138、RX2139、RX2141、RX2142、RX2143、RX2144、RX2146、RX2147、RX2148、RX2149、RX2150、
RX2151、RX2152、RX2153、RX2154、RX2155、RX2156、RX2157、RX2158、RX2159、RX2160、RX2161、
RX2162、RX2163、RX2164、RX2165、RX2166、RX2167、RX2169、RX3171、RX3173、RX3174、RX3175、
RX3176、RX3177、RX3178、RX3179、RX3180、RX3181、RX3183、RX3184、RX3185、RX3186、RX3187、
RX3188、RX3189、RX3190、RX3191、RX3192、RX3193、RX3194、RX3195、RX3196、RX3197、RX3198、
RX3200、RX3201、RX3202、RX3203、RX3204、RX3205、RX3206、RX3207、RX3208、RX3209、RX3210、
RX3211、RX3212、RX3213、RX3214、RX3215、RX3216、RX3217、RX3218、RX3219、RX3220、RX3221、
RX3222、RX3223、RX3224、RX3225、RX3226、RX3227、RX3228、RX3229、RX3230、RX3231、RX3232、
RX3233、RX3234、RX3235、RX3236、RX3237、RX3238、RX3239、RX3240、RX3241、RX3242、RX4243、
RX4244、RX4245、RX4246、RX4247、RX4248、RX4249、RX4250、RX4251、RX4252、RX4253、RX4254、
RX4255、RX4256、RX4257、RX4258、RX4260、RX4261、RX4263、RX4264、RX4265、RX4266、RX4267、
RX4268、RX4269、RX4270、RX4271、RX4272、RX4273、RX4274、RX4275、RX4276、RX4277、RX4278、
RX4279、RX4280、RX4282、RX4283、RX4284、RX4285、RX4286、RX4287、RX4289、RX4290、RX4291、
RX4292、RX4293、RX4294、RX4295、RX4296、RX4297、RX4298、RX4299、RX4300、RX4301、RX4302、
RX4303、RX4304、RX4305、RX4306、RX4307、RX4308、RX4309、RX4310、RX4311、RX4312、RX4313、
RX4315、RX4316、RX4317、RX4318、RX4319、RX4320、RX4321、RX4322、RX4323、RX4324、RX4325、
RX4326、RX4328、RX4329、RX4331、RX4332、RX4333、RX4334、RX4335、RX4336、RX4337、RX4338、
RX4339、RX4340、RX4341、RX4342、RX4343、RX4344、RX4345、RX4346、RX4347、RX4348、RX4349、
RX4350、RX4351、RX4352、RX4353、RX4354、RX4355、RX4356、RX4357、RX4358、RX4359、RX4360、
RX4361、RX4362、RX4366
７７３台

（3）全身用X線CT装置 CT ProSpeed
RF3216、RF6218、RF6219、RF6220、RF6221、RF6222、RF6223、RF6224、RF6225、RF6226、RF6227、
RH5265、RH5273、RH5278、RH5282、RH5284、RH5285、RH6286、RH6287、RH6288、RH6289、RH6290、
RH6292、RH6293、RH6294、RH6295、RH6296、RH6297、RH6298、RH6299、RH6300、RH6301、RH6302、
RH6303、RH6304、RH6305、RH6306、RH6307、RH6308、RH6309、RH6310、RH6311、RH6312、RH6313、
RH6314、RH6315、RH6316、RH6317、RH6318、RH6319、RH6320、RH6321、RH6322、RH6323、RH6324、
RH6325、RH6327、RH6328、RH6329、RH6330、RH6331、RH6332、RH6333、RH6334、RH6335、RH6336、
RH6337、RH6338、RH6339、RH6340、RH6341、RH6342、RH6343、RH6344、RH6345、RH6346、RH6347、
RH6348、RH6349、RH6350、RH6351、RH6352、RH6353、RH6354、RH6355、RH6356、RH6357、RH6358、
RH6359、RH6360、RH6361、RH6362、RH6363、RH6364、RH6365、RH6366、RH6367、RH6368、RH6369、
RH6370、RH6372、RH6373、RH6374、RH6375、RH6376、RH6377、RH6378、RH6379、RH6380、RH6381、
RH6382、RH6383、RH6384、RH6385、RH7386、RH7387、RH7388、RH7389、RH7390、RH7391、RH7392、
RH7393、RH7394、RH7395、RH7396、RH7397、RH7400、RH7401、RH7402、RH7403、RH7404、RH7405、
RH7406、RH7407、RH7408、RH7409、RH7410、RH7411、RH7412、RH7413、RH7414、RH7415、RH7416、
RH7417、RH7418、RH7419、RH7420、RH7421、RH7422、RH7423、RH7424、RH7425、RH7426、RH7427、
RH7428、RH7429、RH7430、RH7431、RH7432、RH7433、RH7435、RH7436、RH7437、RH7438、RH7439、
RH7440、RH7441、RH7442、RH7443、RH7444、RH7445、RH7446、RH7447、RH7448、RH7449、RH7450、
RH7451、RH7452、RH7453、RH7455、RH7456、RH7457、RH7459、RH7461、RH7462、RH7463、RH7464、
RH7465、RH7466、RH7467、RH7468、RH7469、RH7470、RH7471、RH7472、RH7473、RH7474、RH7475、
RH7476、RH7477、RH7478、RH7479、RH7480、RH7481、RH7482、RH7483、RH7484、RH7485、RH7486、
RH7487、RH7488、RH7489、RH7490、RH7491、RH7492、RH7493、RH7494、RH7495、RH7496、RH7497、
RH7498、RH7500、RH7501、RH7502、RH7504、RH7505、RH7506、RH7507、RH7508、RH7509、RH7510、
RH7511、RH7512、RH7513、RH7514、RH7515、RH7516、RH7517、RH7518、RH7519、RH7520、RH7521、
RH7522、RH7523、RH7524、RH7525、RH7526、RH7527、RH7528、RH7530、RH7532、RH7533、RH7534、
RH7535、RH7536、RH7537、RH7538、RH7539、RH7540、RH7541、RH7542、RH7543、RH7544、RH7545、
RH7546、RH7547、RH7548、RH7549、RH7550、RH7551、RH7552、RH7554、RH7555、RH7556、RH7557、
RH7558、RH7559、RH7560、RH7561、RH7562、RH7563、RH7564、RH7565、RH7566、RH7567、RH7569、
RH7570、RH7571、RH7572、RH7573、RH7574、RH7575、RH7576、RH7577、RH7578、RH7579、RH7580、
RH7581、RH7582、RH7583、RH7584、RH7585、RH8586、RH8587、RH8588、RH8590、RH8591、RH8592、
RH8593、RH8595、RH8597、RI7001、RI7002、RI7003、RI7004、RI7005、RI7006、RI7007、RI7008、
RI7009、RI7010、RI7011、RI7012、RI7013、RI7014、RI7015、RI7016、RI7017、RI7018、RI7019、
RI7020、RI7021、RI7022、RI7023、RI7024、RI7025、RI7026、RI7027、RI7028、RI7029、RI7030、
RI7031、RI7032、RI7034、RI7035、RI7036、RI7037、RI7038、RI7039、RI7040、RI7041、RI7043、
RI7044、RI7045、RI7050、RI7052、RI7055、RI7070、RI7077、RI7100、RX4363、RX4364、RX4365、
RX4367、RX4368、RX4369、RX4370、RX4371、RX4372、RX4373、RX4374、RX6375、RX6377、RX6380、
RX6400、RX6410
３７６台

数量      ： 計１５７８台
出荷時期  ： 平成　１０年１０月 〜 平成２０年１０月

  3. 製造販売業者等名称

    4. 製造販売業者の名称  ： ジーイー横河メディカルシステム株式会社
製造販売業者の所在地： 東京都日野市旭が丘４‐７‐１２７
許可の種類          ： 第一種医療機器製造販売業
許可番号            ： １３Ｂ１Ｘ００１５０
輸入先製造業者　　　：　　GE Medical Systems（アメリカ合衆国）
　　　　　　　　　　　　　GE Hangwei Medical Systems Co Ltd.（中華人民共和国）

  4. 改修理由

    5. 当該装置のコリメータにおいて、外国製造所で内部評価試験を行っていたところＩＥＣ規格で規定された以上の
漏れＸ線が出ていた事が確認されました。これはコリメータ内部の開口制御機構部分によるＸ線の散乱によっ
て、規定を超える漏洩が生じるものであり、一次線は本事象の影響を受けません。弊社においては、対象装置に
対して、コリメータからの漏洩に対し規定に入るようにする改修作業を決定致しました。

  5. 危惧される具体的な健康被害

    6. 散乱線による漏れＸ線の増加が患者および撮影室内の使用者に与える影響はマニュアルに記載された散乱線分布
の値以内です。また、漏洩による照射量の増加は通常診断で用いられる照射量の変動範囲内です。従って、この
問題による健康被害の可能性は低いと考えております。なお、これまでに国内外とも健康被害は報告されており
ません。

  6. 改修開始年月日

    7. 平成20年10月14日  情報提供の開始

  7. 効能・効果又は用途等

    8. 患者に関する多方向からのX線透過信号をコンピュータ処理し、再構成画像を診療のために提供するものです。

  8. その他

    9. 納入いたしました医療機関はすべて弊社が把握しておりますので、連絡の上、改修を実施します。

  9. 担当者及び連絡先

    10. 担当者  ： 品質保証本部　市販後安全監視室
           財部　健・山田　藤昭
連絡先  ： ジーイー横河メディカルシステム株式会社
           東京都日野市旭が丘４‐７‐１２７
電話番号： ０４２‐５８５‐５８１１
FAX番号 ： ０４２‐５８５‐５９１１