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平成21年 4月22日作成 平成21年 5月15日訂正(*)
一般名及び販売名
一般的名称： 酸素濃縮装置 販売名 ： (1)ハイサンソ TO-90-5H (2)ハイサンソ TO-90-7H
対象ロット、数量及び出荷時期
ハイサンソ TO-90-5H (*) HE010005 HE010015 HE010017 HE010021 HE010026 HE010029 HE010030 HE010031 HE010039 HE010052 HE010054 HE010056 HE010072 HE010074 HE010078 HE010080 HE010085 HE010089 HE020006 HE020009 HE020010 HE020016 HE020020 HE020027 HE020036 HE020037 HE020052 HE020056 HE020057 HE020066 HE020071 HE020073 HE020079 HE020080 HE020083 HE020086 HE020087 HE020088 HE020090 HE020091 HE020092 HE020094 HE020099 HE030009 HE030016 HE030031 HE030036 HE030040 HE030042 HE030044 HE030055 HE030058 HE030060 HE030064 HE030072 HE030078 HE030085 HE030086 HE030088 HE030089 HE030094 HE030103 HE030107 HE030109 HE030112 HE030117 HE030122 HE030128 HE030135 HE030136 HE040006 HE040011 HE040021 HE040026 HE040035 HE040040 HE040041 HE040044 HE040050 HE040054 HE040061 HE040064 HE040078 HE040079 HE040080 HE040086 HE040089 HE040091 HE040104 HE040111 HE040114 HE040122 HE040123 HE040126 HE040137 HE040145 HE040150 HE040160 HE040161 HE040163 HE040171 HE040172 HE040178 HE040182 HE040184 HE040185 HE040195 HE040196 HE040206 HE050029 HE050036 HE050055 HE050056 HE050075 HE050087 HE050088 HE050092 HE050095 HE050098 HE050099 HE050104 HE050105 HE050115 HE050126 HE050127 HE050129 HE050132 HE050135 HE050139 HE050147 HE050149 HE050151 HE050156 HE050170 HE050172 HE050181 HE050190 HE050192 HE050195 HE050202 HE050207 HE050208 HE060013 HE060018 HE060021 HE060038 HE060045 HE060051 HE060052 HE060053 HE060057 HE060059 HE060061 HE060069 HE060072 HE060076 HE060079 HE060080 HE060083 HE060090 HE060093 HE060096 HE060099 HE060104 HE060112 HE060117 HE060121 HE060122 HE060133 HE060141 HE060142 HE060149 HE060153 HE060155 HE060160 HE060162 HE060163 HE060164 HE060165 HE060166 HE060168 HE060179 HE060192 HE060194 HE060197 HE060198 HE060200 HE060204 HE060207 HE060218 HE070011 HE070013 HE070015 HE070016 HE070021 HE070022 HE070023 HE070028 HE070031 HE070044 HE070058 HE070061 HE070064 HE070073 HE070075 HE070092 HE070093 HE070098 HE070111 HE070124 HE070132 HE070135 HE070138 HE070146 HE070147 HE070149 HE070150 HE070154 HE070160 HE070162 HE070169 HE070170 HE070173 HE070182 HE070183 HE070186 HE070191 HE070200 HE070207 HE070221 HE070222 HE070226 HE070229 HE070233 HE070234 HE070237 HE070238 HE070240 HE070241 HE070242 HE070244 HE070248 HE070253 HE070260 HE070267 HE070269 HE070270 HE070276 HE080003 HE080008 HE080011 HE080026 HE080029 HE080033 HE080035 HE080047 HE080050 HE080051 HE080058 HE080059 HE080066 HE080067 HE080069 HE080087 HE080088 HE080096 HE080099 HE080102 HE080103 HE080104 HE080106 HE080107 HE080111 HE080112 HE080123 HE080135 HE080142 HE080143 HE080151 HE080158 HE080161 HE080169 HE080170 HE080181 HE080184 HE080188 HE080190 HE080193 HE080201 HE080209 HE080218 HE080220 HE080230 HE080235 HE080242 HE080246 HE080247 HE080249 HE080250 HE080252 HE080253 HE080268 HE080274 HE080278 HE080279 HE080281 HE080283 HE080287 HE080291 HE090007 HE090010 HE090012 HE090017 HE090018 HE090025 HE090032 HE090033 HE090048 HE090052 HE090054 HE090059 HE090060 HE090064 HE090065 HE090067 HE090073 HE090082 HE090084 HE090087 HE090090 HE090098 HE090110 HE090112 HE090114 HE090116 HE090117 HE090119 HE090124 HE090126 HE090129 HE090130 HE090140 HE090146 HE090151 HE090161 HE090164 HE090168 HE090170 HE090172 HE090180 HE090182 HE090190 HE090208 HE090213 HE090220 HE090228 HE090230 HE090236 HE090237 HE090242 HE090243 HE090246 HE090264 HE090265 HE090268 HE090277 HE090282 HE090289 HE090292 HE090297 HE0A0005 HE0A0006 HE0A0009 HE0A0010 HE0A0012 HE0A0014 HE0A0016 HE0A0024 HE0A0026 HE0A0032 HE0A0036 HE0A0054 HE0A0058 HE0A0060 HE0A0064 HE0A0070 HE0A0075 HE0A0092 HE0A0093 HE0A0097 HE0A0101 HE0A0110 HE0A0116 HE0A0119 HE0A0123 HE0A0126 HE0A0127 HE0A0130 HE0A0138 HE0A0145 HE0A0159 HE0A0166 HE0A0171 HE0A0180 HE0A0181 HE0A0182 HE0A0185 HE0A0186 HE0A0191 HE0A0196 HE0A0198 HE0A0201 HE0A0205 HE0A0209 HE0A0210 HE0A0215 HE0A0216 HE0A0217 HE0A0222 HE0A0230 HE0B0011 HE0B0016 HE0B0018 HE0B0025 HE0B0036 HE0B0042 HE0B0043 HE0B0045 HE0B0049 HE0B0051 HE0B0057 HE0B0060 HE0B0062 HE0B0077 HE0B0078 HE0B0080 HE0B0090 HE0B0099 HE0B0113 HE0B0119 HE0B0123 HE0B0126 HE0B0134 HE0B0146 HE0B0147 HE0B0155 HE0B0158 HE0B0159 HE0B0166 HE0B0167 HE0B0170 HE0B0183 HE0B0186 HE0B0193 HE0B0196 HE0B0199 HE0B0200 HE0B0202 HE0B0203 HE0B0208 HE0B0209 HE0B0214 HE0B0218 HE0B0220 HE0C0011 HE0C0014 HE0C0017 HE0C0022 HE0C0025 HE0C0026 HE0C0027 HE0C0046 HE0C0051 HE0C0057 HE0C0068 HE0C0072 HE0C0074 HE0C0079 HE0C0081 HE0C0088 HE0C0118 HE0C0124 HE0C0125 HE0C0126 HE0C0127 HE0C0131 HE0C0135 HE0C0136 HE0C0141 HE0C0144 HE0C0145 HE0C0146 HE0C0155 HE0C0161 HE0C0169 HE0C0181 HE0C0182 HE0C0198 HE0C0200 HE0C0205 HE0C0215 HE0C0220 HE110001 HE110009 HE110017 HE110021 HE110025 HE110027 HE110034 HE110038 HE110041 HE110043 HE110045 HE110046 HE110050 HE110051 HE110054 HE110058 HE110061 HE110067 HE110068 HE110074 HE110076 HE110083 HE110086 HE110089 HE110094 HE110096 HE110099 HE110102 HE110104 HE110119 HE110122 HE110124 HE110126 HE110127 HE110132 HE110135 HE110140 HE110143 HE110150 HE110151 HE110153 HE110158 HE110159 HE110165 HE110170 HE110177 HE110180 HE110183 HE110195 HE110202 HE110205 HE110213 HE110217 HE120009 HE120011 HE120014 HE120018 HE120019 HE120022 HE120028 HE120029 HE120032 HE120037 HE120040 HE120044 HE120048 HE120054 HE120063 HE120070 HE120075 HE120082 HE120089 HE120092 HE120096 HE120099 HE120101 HE120104 HE120107 HE120113 HE120115 HE120118 HE120121 HE120126 HE120129 HE120142 HE120143 HE120145 HE120154 HE120156 HE120158 HE120163 HE120164 HE120174 HE120188 HE120190 HE120195 HE120198 HE120199 HE120201 HE120203 HE120204 HE130002 HE130005 HE130006 HE130019 HE130021 HE130023 HE130024 HE130044 HE130046 HE130050 HE130054 HE130057 HE130062 HE130064 HE130070 HE130073 HE130074 HE130079 HE130080 HE130082 HE130085 HE130086 HE130093 HE130096 HE130100 HE130101 HE130108 HE130109 HE130116 HE130120 HE130127 HE130137 HE130140 HE130148 HE130149 HE130151 HE130157 HE130159 HE130160 HE130162 HE130170 HE130176 HE130179 HE130180 HE130185 HE130186 HE130192 HE130195 HE130198 HE130200 HE130202 HE130214 HE130215 HE140001 HE140004 HE140014 HE140018 HE140027 HE140035 HE140036 HE140038 HE140039 HE140042 HE140043 HE140047 HE140054 HE140060 HE140075 HE140076 HE140085 HE140088 HE140090 HE140091 HE140094 HE140098 HE140102 HE140104 HE140107 HE140111 HE140120 HE140121 HE140124 HE140126 HE140128 HE140135 HE140136 HE140142 HE140156 HE140162 HE140163 HE140172 HE140177 HE140179 HE140181 HE140183 HE140191 HE140204 HE140223 HE140228 HE140229 HE140239 HE140245 HE140247 HE140250 HE150001 HE150002 HE150009 HE150012 HE150016 HE150025 HE150026 HE150056 HE150065 HE150068 HE150076 HE150081 HE150086 HE150087 HE150090 HE150093 HE150109 HE150123 HE150126 HE150131 HE150133 HE150136 HE150139 HE150153 HE150158 HE150159 HE150176 HE150177 HE150187 HE150204 HE150208 HE150213 HE150217 HE150218 HE150224 HE150233 HE150234 HE150243 HE150248 HE150254 HE160008 HE160010 HE160021 HE160022 HE160031 HE160035 HE160046 HE160047 HE160051 HE160067 HE160068 HE160071 HE160075 HE160079 HE160080 HE160085 HE160090 HE160094 HE160111 HE160112 HE160117 HE160118 HE160122 HE160127 HE160135 HE160136 HE160147 HE160156 HE160173 HE160179 HE160181 HE160195 HE160200 HE160203 HE160208 HE160214 HE160219 HE160224 HE160226 HE170006 HE170024 HE170026 HE170029 HE170036 HE170039 HE170040 HE170043 HE170046 HE170052 HE170069 HE170075 HE170086 HE170087 HE170088 HE170092 HE170095 HE170097 HE170107 HE170108 HE170128 HE170131 HE170133 HE170138 HE170144 HE170168 HE170170 HE170175 HE170176 HE180005 HE180006 HE180009 HE180014 HE180015 HE180023 HE180027 HE180028 HE180030 HE180068 HE180092 HE180093 HE180095 HE180108 HE180115 HE180118 HE180124 HE180139 HE180141 HE180148 HE180157 HE180159 HE180162 HE180163 HE190006 HE190009 HE190013 HE190014 HE190015 HE190023 HE190031 HE190032 HE190034 HE190039 HE190042 HE190046 HE190048 HE190051 HE190062 HE190067 HE190068 HE190072 HE190073 HE190074 HE190081 HE190088 HE190096 HE190097 HE190101 HE190103 HE190104 HE190114 HE190117 HE190118 HE190123 HE190135 HE190156 HE190157 HE190159 HE1A0017 HE1A0020 HE1A0022 HE1A0030 HE1A0031 HE1A0033 HE1A0036 HE1A0039 HE1A0040 HE1A0048 HE1A0049 HE1A0050 HE1A0053 HE1A0068 HE1A0076 HE1A0085 HE1A0097 HE1A0098 HE1A0106 HE1A0107 HE1A0115 HE1A0119 HE1A0128 HE1A0132 HE1A0136 HE1A0141 HE1A0145 HE1A0151 HE1A0155 HE1A0157 HE1A0159 HE1A0161 HE1A0162 HE1A0167 HE1A0187 HE1A0189 HE1A0198 HE1A0200 HE1B0004 HE1B0011 HE1B0012 HE1B0013 HE1B0018 HE1B0024 HE1B0028 HE1B0031 HE1B0033 HE1B0034 HE1B0036 HE1B0037 HE1B0049 HE1B0072 HE1B0099 HE1B0113 HE1B0120 HE1B0124 HE1B0130 HE1B0139 HE1B0154 HE1B0158 HE1B0161 HE1B0167 HE1B0168 HE1B0175 HE1B0181 HE1B0182 HE1B0193 HE1B0199 HE1B0200 HE220006 HE220010 HE220014 HE220016 HE220019 HE220023 HE220024 HE220026 HE220028 HE220033 HE220039 HE230004 HE230006 HE230022 HE230023 HE230027 HE230030 HE230033 HE230036 HE230043 HE230044 HE230048 HE230050 HE230055 HE230059 HE240007 HE240014 HE240015 HE240018 HE240032 HE240035 HE240048 HE240059 HE240069 HE240077 HE240080 HE240088 HE240091 HE240096 HE250004 HE250007 HE250009 HE250014 HE250019 HE250020 HE250029 HE250035 HE250054 HE250055 HE250056 HE250060 HE250067 HE250068 HE250071 HE250072 HE250073 HE250075 HE250078 HE250084 HE250096 HE250100 HE260002 HE260015 HE260017 HE260019 HE260023 HE260026 HE260032 HE260033 HE260040 HE260043 HE260048 HE270010 HE270014 HE270020 HE270021 HE270022 HE270029 HE270036 HE270048 HE280008 HE280020 HE280025 HE280026 HE280034 HE280037 HE280039 HE280041 HE280045 HE290002 HE290003 HE290019 HE290021 HE290026 HE290028 HE290030 HE290033 HE290041 HE290046 HE2A0001 HE2A0002 HE2A0003 HE2A0014 HE2A0028 HE2A0035 HE2A0046 HE2A0050 HE2B0001 HE2B0021 HE2B0028 HE2B0030 HE2B0033 HE2B0034 HE2B0035 HE2B0038 HE2B0039 HE2B0043 HE2B0044 HE2C0003 HE2C0006 HE2C0017 HE2C0025 HE2C0032 HE2C0033 HE2C0034 HE2C0036 HE2C0037 HE2C0047 HE2C0050 HE9A0005 HE9A0006 HE9A0024 HE9A0037 HE9A0046 HE9A0047 HE9A0048 HE9A0050 HE9A0072 HE9A0081 HE9A0090 HE9A0095 HE9A0101 HE9A0110 HE9A0111 HE9A0120 HE9A0125 HE9A0138 HE9A0146 HE9B0007 HE9B0013 HE9B0014 HE9B0027 HE9B0028 HE9B0033 HE9B0038 HE9B0042 HE9B0053 HE9B0058 HE9B0067 HE9B0069 HE9B0070 HE9B0086 HE9B0094 HE9C0004 HE9C0011 HE9C0014 HE9C0016 HE9C0033 HE9C0042 HE9C0050 HE9C0053 HE9C0061 HE9C0071 HE9C0073 HE9C0082 HE9C0088 HE9C0099 HE9C0103 HE9C0104 HE9C0106 HE9C0110 HE9C0111 HE9C0118 HE9C0124 HE9C0128 HE9C0134 HE9C0136 HE9C0144 HE9C0145 HE9C0147 HE9C0161 HE9C0172 HE9C0177 HE9C0179 HE9C0186 HE9C0187 HE9C0188 HE9C0189 HE9C0193 HE9C0197 HE9C0198 HE9C0200 ハイサンソ TO-90-7H (*) HG010018 HG010027 HG010045 HG010046 HG010049 HG010073 HG010078 HG010085 HG010086 HG010096 HG010100 HG010104 HG010117 HG010119 HG010121 HG010123 HG010129 HG010135 HG010136 HG020002 HG020013 HG020018 HG020044 HG020054 HG020062 HG020065 HG020071 HG020089 HG020110 HG020112 HG020123 HG020127 HG020136 HG020137 HG020139 HG020142 HG020144 HG020146 HG020147 HG020148 HG030008 HG030045 HG030050 HG030053 HG030064 HG030074 HG030077 HG030101 HG030105 HG030110 HG030118 HG030122 HG030123 HG030130 HG030134 HG030135 HG030136 HG030137 HG030140 HG040015 HG040022 HG040025 HG040036 HG040040 HG040046 HG050003 HG050010 HG050020 HG050022 HG050032 HG050035 HG050036 HG050039 HG050040 HG060011 HG060015 HG060021 HG060026 HG060028 HG060038 HG060041 HG060054 HG060062 HG060063 HG060066 HG060069 HG060072 HG060079 HG070005 HG070010 HG070011 HG070026 HG070028 HG070037 HG070040 HG070041 HG070042 HG070043 HG070052 HG070064 HG070070 HG080010 HG080018 HG080021 HG080036 HG080040 HG080044 HG080047 HG080049 HG080056 HG080061 HG080064 HG080069 HG090006 HG090011 HG090012 HG090016 HG090029 HG090042 HG090054 HG090057 HG090058 HG090060 HG090062 HG0A0021 HG0A0028 HG0A0036 HG0A0038 HG0A0044 HG0A0049 HG0B0001 HG0B0027 HG0B0029 HG0B0036 HG0B0037 HG0B0042 HG0B0043 HG0B0055 HG0B0061 HG0B0066 HG0B0069 HG0C0014 HG0C0019 HG0C0027 HG0C0032 HG0C0036 HG0C0042 HG0C0043 HG0C0045 HG0C0046 HG0C0048 HG0C0052 HG0C0061 HG0C0063 HG0C0066 HG0C0071 HG0C0072 HG110004 HG110008 HG110019 HG110021 HG110026 HG110031 HG110037 HG110040 HG120006 HG120011 HG120016 HG120023 HG120025 HG120038 HG120039 HG130004 HG130010 HG130023 HG130026 HG130039 HG160002 HG160003 HG160012 HG160019 HG160023 HG160026 HG160027 HG160029 HG170001 HG170002 HG170008 HG170018 HG170023 HG170048 HG170052 HG170053 HG180001 HG180008 HG180026 HG180033 HG180037 HG180040 HG190002 HG190010 HG190016 HG190019 HG190021 HG190033 HG190037 HG190038 HG1A0001 HG1A0002 HG1A0011 HG1A0031 HG1A0035 HG1C0011 HG1C0018 HG1C0022 HG210005 HG220011 HG230001 HG230014 HG230015 HG240001 HG240002 HG240007 HG240017 HG240018 HG240022 HG240026 HG240028 HG240030 HG260006 HG260027 HG260048 HG260055 HG260056 HG260066 HG260073 HG260076 HG260077 HG260082 HG260083 HG260085 HG260087 HG260100 HG260112 HG260115 HG260120 HG290001 HG290003 HG290014 HG290018 HG290025 HG290027 HG290028 HG290034 HG290036 HG290037 HG290043 HG290051 HG2B0008 HG2B0013 HG2B0021 HG2B0023 HG2B0024 HG310005 HG310008 HG320001 HG320013 HG320015 HG320018 HG330016 HG330018 HG450001 HG450003 HG460005 HG460007 HG460008 HG460016 HG480011 HG480018 HG480025 HG480026 HG480032 HG480037 HG480040 HG490001 HG490005 HG490010 HG490011 HG490020 HG490028 HG490033 HG490034 HG4A0007 HG510009 HG510013 HG510014 HG520006 HG520010 HG520015 HG520020 HG520021 HG530006 HG530009 HG530013 HG530014 HG530015 HG530017 HG530018 HG530020 HG540004 HG540022 HG540030 HG540039 HG540047 HG540048 HG550012 HG550018 HG550022 HG550028 HG550038 HG550039 HG550043 HG550045 HG550048 HG550049 HG560016 HG560022 HG560030 HG560031 HG560037 HG560043 HG560047 HG570002 HG570005 HG570024 HG570028 HG570033 HG570039 HG570041 HG570045 HG570046 HG570049 HG570051 HG580005 HG580015 HG580017 HG580022 HG580024 HG580031 HG580043 HG580044 HG580049 HG580057 HG580062 HG580067 HG580078 HG590014 HG590019 HG590029 HG590031 HG590033 HG590034 HG590038 HG590047 HG590048 HG590049 HG590050 HG590051 HG590060 HG590061 HG590063 HG590072 HG590076 HG590078 HG590085 HG590086 HG590087 HG590090 HG590091 HG590092 HG590094 HG590098 HG590101 HG590102 HG590108 HG590109 HG5A0010 HG5A0015 HG5A0027 HG5A0028 HG5A0033 HG5A0035 HG5A0036 HG5A0037 HG5A0048 HG5A0054 HG5A0058 HG5A0060 HG5A0065 HG5A0073 HG5A0074 HG5A0085 HG5A0087 HG5A0089 HG5A0099 HG5A0105 HG5A0107 HG5A0111 HG5A0112 HG5A0120 HG5B0009 HG5B0028 HG5B0045 HG5B0058 HG5C0008 HG5C0009 HG5C0015 HG5C0018 HG5C0020 HG610027 HG620002 HG620004 HG620007 HG620018 HG620019 HG630011 HG630016 HG630019 HG630025 HG640006 HG640026 HG640039 HG640041 HG640057 HG640061 HG640063 HG640064 HG640065 HG640068 HG640069 HG640070 HG640071 HG650001 HG650009 HG650010 HG650011 HG650013 HG650022 HG650023 HG650025 HG650030 HG660001 HG660021 HG660023 HG670010 HG750002 HG760008 HG770008 HG820007 HG820008 HG820009 HG820010 HG850008 HG860006 HG870008 HG9A0002 HG9A0012 HG9A0016 HG9A0035 HG9A0045 HG9A0046 HG9A0048 HG9A0050 HG9A0051 HG9A0053 HG9C0001 HG9C0022 HG9C0024 HG9C0026 HG9C0036 HG9C0040 HG9C0049 HG9C0057 HG9C0063 HG9C0064 HG9C0077 HG9C0083 HG9C0089 HG9C0092 HG9C0095 HG9C0098 HG9C0099 HG9C0106 HG9C0110 HG9C0112 HG9C0116 HG9C0118 HG9C0119 HG9C0121 HG9C0123 HG9C0127 HG9C0130 出荷数量：ハイサンソ TO-90-5H 1,145台 (*) ハイサンソ TO-90-7H 502台 (*) 合計 1,647台 (*) 出荷時期：平成２１年１月７日〜平成２１年４月１４日
製造販売業者等名称
製造販売業者の名称 ： 帝人ファーマ株式会社 製造販売業者の所在地： 東京都千代田区霞が関三丁目２番１号 霞が関コモンゲート西館 許可の種類 ： 第一種医療機器製造販売業 許可番号 ： 13B1X00059
回収理由
酸素濃縮装置ハイサンソTO-90-5H及びハイサンソTO-90-7Hにおきまして、吸着ユニットの切替弁を駆動するモー ターの修理交換用の特定ロットに品質不良品が含まれていたことが判明しました。品質不良品が使用された場 合、モーター停止による機台停止が発生するおそれがあるため、患者様の安全を第一に考え回収を実施します。
危惧される具体的な健康被害
本装置は、病態の安定された患者様に在宅にて使用していただくものであり、本不具合が発生した場合、警報を 発し、酸素の供給が停止します。其の場合、酸素不足により息切れ等の症状が発生する可能性が考えられます が、担当医師の処方により予め酸素ボンベが設置してあり、それを用いることにより対応が可能です。また、弊 社では24時間バックアップ体制を取っており、異常発生の連絡を受け緊急対応が可能であることから、本不具合 による健康被害が発生する可能性は低いと考えます。なお、現在までに、本不具合による健康被害の報告は受け ておりません。
回収開始年月日
平成21年4月17日
効能・効果又は用途等
本装置は、低酸素血症の患者様を対象に酸素吸入療法を実施する際、酸素供給源として使用する装置です。
その他
納入した医療機関、患者様および取引販売会社を全て特定できていますので文書にて通知のうえ、回収作業を実 施いたします。
担当者及び連絡先
担当者 ： 医療保証統括部 川越正孝 連絡先 ： 帝人ファーマ株式会社 〒100-8585 東京都千代田区霞が関三丁目２番１号 霞が関コモンゲート西館 電話番号： 03-3506-4373 FAX番号 ： 03-3506-4625