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令和 5年 3月17日作成
一般的名称及び販売名
一般的名称： 経頭蓋治療用磁気刺激装置 販売名 ： NeuroStar TMS治療装置
対象ロット、数量及び出荷時期
出荷時期 令和4年12月〜令和5年3月 出荷数量：2350個 Senstar Treatment Link J40002162, J40002016, J40002210, J40002035, J40002250 J40002674, J40002154, J40002017, J40002191, J40002343 J40002911, J40001696, J40002213, J40001522, J40002134 J40001854, J40001551, J40002172, J40002633, J40002244 J40002538, J40001013, J40002344, J40001864, J40002508 J40001204, J40002228, J40002625, J40002052, J40001562 J40002444, J40002174, J40002868, J40002153, J40002405 J40001849, J40002939, J40002326, J40001334, J40002863 J40002440, J40002308, J40002395, J40001374, J40001422 J40002156, J40002249, J40002051, J40002346, J40001681 J40001070, J40001035, J40001020, J40001074, J40001072 J40001840, J40001829, J40001885, J40001884, J40001836 J40001848, J40001653, J40001657, J40001625, J40001782 J40001832, J40001833, J40001834, J40001825, J40001691 J40001660, J40001689, J40001055, J40001043, J40001039 J40001287, J40001819, J40001830, J40001809, J40001808 J40001690, J40001649, J40001650, J40001651, J40001652 J40001783, J40001781, J40001820, J40001805, J40001831 J40001844, J40001839, J40001847, J40001837, J40001838 J40002786, J40002571, J40002341, J40002350, J40002372 J40002303, J40002302, J40002428, J40002248, J40002305 J40002403, J40002410, J40002381, J40002404, J40002349 J40002246, J40002304, J40002280, J40002342, J40002278 J40002757, J40002740, J40002799, J40002616, J40002615 J40002429, J40002451, J40002450, J40002449, J40002430 J40002447, J40002448, J40002212, J40002247, J40002431 J40002243, J40002211, J40002241, J40002222, J40002378 J40002407, J40002309, J40002307, J40002333, J40002373 J40002377, J40002380, J40002411, J40002409, J40002408 J40002930, J40002869, J40001887, J40001896, J40002867 J40001061, J40001324, J40001851, J40001054, J40001835 J40001007, J40001009, J40001031, J40001029, J40001168 J40001874, J40001394, J40001030, J40001044, J40001873 J40002890, J40002880, J40002873, J40002866, J40002888 J40001015, J40001001, J40001023, J40001780, J40001886 J40001872, J40001041, J40001046, J40001048, J40001036 J40002946, J40002882, J40002945, J40002944, J40002889 J40001865, J40001859, J40001863, J40001824, J40001869 J40001871, J40001911, J40001914, J40001913, J40001915 J40002932, J40002934, J40002933, J40002904, J40002858 J40002870, J40002903, J40002859, J40002876, J40002877 J40002810, J40002862, J40002964, J40002864, J40002883 J40001880, J40001860, J40001853, J40001822, J40001823 J40002905, J40002857, J40002936, J40002902, J40002908 J40002854, J40002878, J40002872, J40002907, J40002871 J40002809, J40002884, J40002943, J40002942, J40002879 J40001322, J40001099, J40001148, J40001281, J40001279 J40001599, J40001606, J40001601, J40001600, J40001118 J40001603, J40001614, J40001613, J40001612, J40001330 J40001121, J40001120, J40001119, J40001128, J40001604 J40001319, J40001113, J40001112, J40001111, J40001110 J40002019, J40002647, J40002649, J40002755, J40002725 J40002574, J40002560, J40002619, J40002511, J40002457 J40001117, J40001116, J40001115, J40001114, J40001122 J40001609, J40001608, J40001607, J40002528, J40002664 J40002601, J40002535, J40002550, J40002549, J40002534 J40002557, J40002546, J40002545, J40002544, J40002543 J40002501, J40002590, J40002494, J40002530, J40002520 J40002650, J40002679, J40002680, J40002681, J40002687 J40002635, J40002567, J40002636, J40002637, J40002624 J40002532, J40002502, J40002493, J40002503, J40002504 J40002521, J40002527, J40002491, J40002499, J40002555 J40002519, J40002496, J40002487, J40002490, J40002604 J40002605, J40002648, J40002688, J40002643, J40002634 J40002626, J40002638, J40002553, J40002599, J40002618 J40002947, J40001019, J40001150, J40001868, J40001852 J40001878, J40002837, J40002478, J40001037, J40002505 J40001363, J40002347, J40002775, J40002076, J40002881 J40002906, J40002811, J40002910, J40002394, J40002195 J40001397, J40001395, J40002874, J40002097, J40002474 J40002927, J40001056, J40001862, J40002842, J40002839 J40002941, J40001540, J40002792, J40002412, J40002820 J40002345, J40002427, J40002270, J40002396, J40002665 J40002260, J40002126, J40002328, J40002055, J40002287 J40002070, J40001022, J40001889, J40002482, J40002157 J40001267, J40001209, J40001213, J40001266, J40001265 J40001413, J40001459, J40001483, J40001470, J40001484 J40001252, J40001248, J40001455, J40001456, J40001441 J40001437, J40001438, J40001425, J40001418, J40001417 J40001477, J40001405, J40001436, J40001428, J40001486 J40001230, J40001271, J40001228, J40001244, J40001189 J40001247, J40001227, J40001226, J40001246, J40001225 J40001475, J40001400, J40001404, J40001426, J40001427 J40001471, J40001420, J40001476, J40001406, J40001480 J40001472, J40001478, J40001464, J40001465, J40001466 J40002130, J40002010, J40002143, J40002084, J40002034 J40002065, J40002064, J40002063, J40002062, J40002066 J40002127, J40002133, J40002037, J40002125, J40002044 J40002053, J40002054, J40002027, J40002067, J40002036 J40002147, J40002136, J40002050, J40002047, J40002135 J40002057, J40002090, J40002081, J40002032, J40002083 J40002139, J40002129, J40002080, J40002046, J40002048 J40002028, J40002141, J40002042, J40002059, J40002058 J40002186, J40002291, J40002118, J40002105, J40002056 J40002025, J40002024, J40002072, J40002111, J40002205 J40002123, J40002124, J40002114, J40002040, J40002088 J40002113, J40002110, J40002128, J40002119, J40002060 J40002089, J40002011, J40002087, J40002009, J40002015 J40002138, J40002231, J40002005, J40002230, J40002086 J40002002, J40002233, J40002043, J40002078, J40002082 J40002120, J40002121, J40002131, J40002033, J40002041 J40002085, J40002207, J40002008, J40002007, J40002029 J40002013, J40002079, J40002012, J40002115, J40002014 J40002068, J40002004, J40002208, J40002209, J40002104 J40002006, J40002003, J40002232, J40002103, J40002069 J40001288, J40001654, J40001127, J40001645, J40001125 J40001258, J40001250, J40001269, J40001257, J40001270 J40001295, J40001223, J40001268, J40001205, J40001219 J40001297, J40001220, J40001294, J40001221, J40001293 J40001245, J40001256, J40001296, J40001207, J40001208 J40001276, J40001277, J40001278, J40001655, J40001126 J40001235, J40001236, J40001237, J40001274, J40001275 J40001646, J40001124, J40001616, J40001617, J40001618 J40001678, J40001679, J40001694, J40001615, J40001639 J40001644, J40001647, J40001642, J40001643, J40001648 J40001982, J40002001, J40001969, J40001970, J40001981 J40001924, J40001923, J40001922, J40001979, J40001892 J40001978, J40001993, J40001935, J40001990, J40001989 J40001928, J40001930, J40001929, J40001992, J40001988 J40001752, J40001743, J40001730, J40001742, J40001795 J40001956, J40001960, J40001959, J40001958, J40001926 J40001893, J40001894, J40001904, J40001984, J40001977 J40001987, J40001986, J40001891, J40001919, J40001927 J40001740, J40001739, J40001754, J40001753, J40001976 J40001786, J40001772, J40001773, J40001731, J40001732 J40001010, J40001898, J40001179, J40001027, J40001897 J40001145, J40001879, J40001161, J40001057, J40001026 J40001182, J40002805, J40002804, J40002806, J40002808 J40001033, J40001032, J40001160, J40002840, J40002851 J40002766, J40002765, J40002928, J40002931, J40002827 J40002822, J40002856, J40002847, J40002849, J40002819 J40001104, J40001024, J40001096, J40001021, J40001169 J40002728, J40002844, J40002815, J40002732, J40002802 J40001155, J40001876, J40001172, J40002955, J40002956 J40002704, J40002845, J40002702, J40002706, J40002831 J40001675, J40001674, J40001671, J40001672, J40001676 J40001665, J40001669, J40001685, J40001686, J40001687 J40001012, J40001664, J40001698, J40001697, J40001659 J40001688, J40001135, J40001004, J40001005, J40001006 J40002850, J40001582, J40002843, J40002764, J40002807 J40001811, J40001810, J40001784, J40001817, J40001670 J40001683, J40001058, J40001045, J40001038, J40001008 J40001661, J40001662, J40001667, J40001684, J40001682 J40001042, J40001692, J40001693, J40001627, J40001668 J40001899, J40002865, J40002838, J40002922, J40002703 J40002145, J40002168, J40002167, J40002171, J40002183 J40002175, J40002109, J40002108, J40002106, J40002020 J40002021, J40002018, J40002095, J40002094, J40002137 J40002077, J40002184, J40002178, J40002152, J40002023 J40002073, J40002146, J40002038, J40002148, J40002166 J40002107, J40002182, J40002177, J40002173, J40002176 J40002092, J40002161, J40002132, J40002193, J40002192 J40002155, J40002102, J40002163, J40002229, J40002194 J40002149, J40002151, J40002169, J40002158, J40002165 J40002093, J40002159, J40002179, J40002075, J40002074 J40002237, J40002238, J40002289, J40002286, J40002251 J40002321, J40002320, J40002319, J40002283, J40002284 J40002204, J40002323, J40002324, J40002225, J40002224 J40002221, J40002220, J40002253, J40002252, J40002329 J40002398, J40002397, J40002306, J40002483, J40002310 J40002392, J40002199, J40002259, J40002236, J40002240 J40002393, J40002281, J40002201, J40002202, J40002203 J40002340, J40002330, J40002188, J40002187, J40002214 J40002190, J40002189, J40002401, J40002400, J40002399 J40002276, J40002406, J40002223, J40002219, J40002218 J40002327, J40002039, J40002030, J40001953, J40001588 J40002588, J40001398, J40001210, J40001818, J40001900 J40002846, J40001916, J40002848, J40001292, J40002940 J40002891, J40002413, J40001867, J40001025, J40002576 J40002950, J40002852, J40002707, J40001881, J40002841 J40001695, J40002652, J40001481, J40001870, J40002536 J40002022, J40001850, J40001912, J40002875, J40002628 J40001176, J40001962, J40002196, J40002091, J40001291 J40002160, J40002912, J40002897, J40001431, J40002348 J40002823, J40002803, J40002821, J40001925, J40001028 J40002298, J40002122, J40002031, J40002142, J40002117 J40002282, J40002026, J40002274, J40002266, J40002273 J40002265, J40002311, J40002312, J40002227, J40002226 J40002269, J40002267, J40002272, J40002271, J40002299 J40002217, J40002297, J40002216, J40002296, J40002415 J40002150, J40002197, J40002254, J40002314, J40002325 J40002445, J40002318, J40002264, J40002317, J40002316 J40002268, J40002315, J40002313, J40002443, J40002294 J40002256, J40002215, J40002275, J40002288, J40002414 J40002258, J40002257, J40002575, J40002552, J40002617 J40002737, J40002741, J40002794, J40002734, J40002733 J40002480, J40002518, J40002517, J40002551, J40002735 J40002640, J40002762, J40002760, J40002759, J40002756 J40002798, J40002782, J40002769, J40002712, J40002713 J40002745, J40002744, J40002743, J40002742, J40002783 J40002750, J40002770, J40002894, J40002895, J40002896 J40002433, J40002436, J40002507, J40002435, J40002509 J40002516, J40002351, J40002352, J40002434, J40002721 J40002796, J40002795, J40002747, J40002748, J40002749 J40001158, J40001610, J40001636, J40001637, J40001638 J40001109, J40001632, J40001159, J40001605, J40001162 J40001286, J40001183, J40001184, J40001185, J40001186 J40001181, J40001188, J40001093, J40001092, J40001091 J40001178, J40001134, J40001131, J40001133, J40001132 J40001629, J40001123, J40001396, J40001393, J40001359 J40001157, J40001156, J40001354, J40001624, J40001631 J40001621, J40001626, J40001283, J40001284, J40001285 J40001187, J40001098, J40001097, J40001094, J40001173 J40001089, J40001095, J40001174, J40001175, J40001177 J40002180, J40002112, J40002292, J40002301, J40002337 J40002293, J40002355, J40002438, J40002388, J40002441 J40002670, J40002140, J40002164, J40002144, J40002662 J40002515, J40002300, J40002295, J40002561, J40002691 J40002481, J40002475, J40002100, J40002045, J40002049 J40002541, J40002510, J40002255, J40002439, J40002484 J40002584, J40002562, J40002695, J40002761, J40002513 J40002736, J40002773, J40002790, J40002606, J40002489 J40002631, J40002893, J40002892, J40002900, J40002245 J40002898, J40002899, J40002730, J40002660, J40002659 J40002389, J40002463, J40002338, J40002382, J40002354 J40002384, J40002467, J40002385, J40002462, J40002466 J40002470, J40002339, J40002367, J40002365, J40002357 J40002418, J40002387, J40002514, J40002476, J40002390 J40002453, J40002334, J40002362, J40002335, J40002242 J40002358, J40002512, J40002425, J40002424, J40002423 J40002356, J40002432, J40002456, J40002353, J40002455 J40002522, J40002531, J40002422, J40002371, J40002370 J40002699, J40002700, J40002701, J40002460, J40002540 J40001003, J40001141, J40001084, J40001071, J40001136 J40002529, J40002580, J40002579, J40002578, J40002577 J40001165, J40001081, J40001078, J40001079, J40001164 J40002366, J40002539, J40002473, J40002472, J40002471 J40002386, J40002458, J40002459, J40002461, J40002464 J40002465, J40002537, J40002469, J40002383, J40002468 J40001064, J40001065, J40001059, J40001180, J40001060 J40001199, J40001200, J40001290, J40001198, J40001197 J40001272, J40001273, J40001289, J40001260, J40001259 J40001212, J40001203, J40001206, J40001202, J40001196 J40001138, J40001139, J40001140, J40001130, J40001090 J40001222, J40001253, J40001255, J40001254, J40001239 J40001233, J40001231, J40001229, J40001201, J40001190 J40001261, J40001262, J40001263, J40001240, J40001238 J40001744, J40001733, J40001751, J40001771, J40001729 J40001760, J40001741, J40001747, J40001764, J40001794 J40001770, J40001734, J40001749, J40001797, J40001796 J40001715, J40001714, J40001716, J40001717, J40001745 J40001791, J40001792, J40001761, J40001699, J40001700 J40001787, J40001785, J40001767, J40001768, J40001799 J40001750, J40001735, J40001736, J40001738, J40001737 J40001777, J40001774, J40001762, J40001763, J40001718 J40001746, J40001798, J40001788, J40001789, J40001790 J40001709, J40001710, J40001705, J40001706, J40001707 J40001506, J40001533, J40001500, J40001505, J40001499 J40001946, J40001975, J40001917, J40001918, J40001991 J40001578, J40001573, J40001574, J40001579, J40001519 J40001994, J40001965, J40001964, J40001963, J40001985 J40001920, J40001936, J40001937, J40001967, J40001966 J40001586, J40001587, J40001512, J40001510, J40001534 J40001516, J40001515, J40001514, J40001939, J40001940 J40001906, J40001907, J40001931, J40001983, J40001938 J40001957, J40001952, J40001980, J40001950, J40001949 J40001137, J40001087, J40001088, J40001034, J40001073 J40001146, J40001083, J40001085, J40001149, J40001086 J40001166, J40001014, J40001075, J40001170, J40001053 J40001052, J40001167, J40001282, J40001002, J40001082 J40001051, J40000999, J40001040, J40001152, J40001049 J40001144, J40001143, J40001080, J40001142, J40001000 J40001163, J40001077, J40001151, J40001171, J40001076 J40001153, J40001018, J40001017, J40001154, J40001016 J40001280, J40002901, J40002781, J40002739, J40002752 J40002639, J40002644, J40002641, J40002651, J40002533 J40001948, J40001932, J40001947, J40001934, J40001903 J40001556, J40001538, J40001536, J40001537, J40001539 J40001724, J40001720, J40001728, J40001722, J40001973 J40001997, J40001999, J40002000, J40001998, J40001961 J40001955, J40001974, J40001971, J40001972, J40001968 J40004164, J40004163, J40004162, J40004126, J40004131 J40004120, J40004124, J40004125, J40004166, J40004165 J40004092, J40004091, J40004123, J40004122, J40004121 J40004096, J40004090, J40004095, J40004094, J40004093 J40004083, J40004101, J40004099, J40004098, J40004097 J40004102, J40004078, J40004067, J40004082, J40004086 J40004081, J40004080, J40004079, J40004085, J40004084 J40004100, J40004105, J40004104, J40004089, J40004088 J40004087, J40004068, J40004119, J40004075, J40004073 J40004069, J40004076, J40004072, J40004074, J40004077 J40003798, J40003793, J40003803, J40003799, J40003797 J40003807, J40003806, J40003805, J40003804, J40003800 J40003812, J40003811, J40003810, J40003809, J40003808 J40003819, J40003817, J40003816, J40003815, J40003814 J40003821, J40003820, J40003826, J40003825, J40003824 J40003818, J40003792, J40003823, J40003850, J40003822 J40003794, J40003791, J40003790, J40003796, J40003795 J40003777, J40003813, J40003829, J40003828, J40003827 J40003836, J40003835, J40003834, J40003830, J40003784 J40003833, J40003842, J40003839, J40003838, J40003837 J40004552, J40004551, J40004550, J40004549, J40004547 J40004553, J40004556, J40004548, J40004543, J40004538 J40004545, J40004544, 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製造販売業者等名称
製造販売業者の名称 ： ヴォーパル・テクノロジーズ株式会社 製造販売業者の所在地： 東京都中央区日本橋本石町三丁目3番16号 日本橋室町ビル 許可の種類 ： 第一種医療機器製造販売業 許可番号 ： 13B1X10172 製造業者：Neuronetics, Inc.（アメリカ合衆国）
改修理由
当該製品の外箱に表示されている特定用符号に誤りがあり、添付文書が表示されないGS1バーコードラベルが貼 付された製品が市場に出荷されたことが判明したため、対象製品の自主改修を行います。
危惧される具体的な健康被害
本改修は特定用符号の表示の不備にかかるものであり、機器の性能、安全性には影響しないため、当該製品の使 用が健康被害の原因となることは考えられません。添付文書は書面で製品と同梱して出荷しており、その内容は 最新版です。 これまで本件に関する健康被害の報告は受けておりません。
改修開始年月日
令和5年3月17日 （情報提供開始：令和5年3月3日）
効能・効果又は用途等
本品はパルス磁場を用いて脳皮質の局所領域に電流を誘導し、ニューロンを刺激することによって、成人のうつ 病患者（既存の抗うつ剤治療で十分な効果が認められない場合に限る）の治療に用いる。
その他
納入先施設は把握しておりますので、納入先施設に正しい特定用符号に関する情報提供を行い、未使用の外箱に つきましては正しいバーコードラベルを貼付いたします。
担当者及び連絡先
担当者 ： 信頼性保証本部 品質保証部 手代木 万里 連絡先 ： ヴォーパル・テクノロジーズ株式会社 電話番号： 03-5544-8340