平成26年11月4日作成

一般的名称： 乾式ホットパック装置
販売名　　： サーモフォアー

対象数量：1593台
出荷期間：平成20年11月4日より平成26年9月30日まで
対象ロット：
201024,201025,201026,201027,201028,201029,201030,201031,201032,201033,201034,200356,200490,200353,
201035,201036,201038,201039,201040,201041,201042,201044,200481,200482,200483,200484,201043,200485,
200486,200487,200488,200491,200492,200349,200350,200351,200352,200354,200355,200357,200358,200359,
200360,200489,200497,200498,200553,200778,200877,200878,200879,200880,200881,200882,200883,200884,
200886,200887,200888,201129,201130,201131,201132,201133,201134,201135,200885,201136,201137,200100,
200554,200103,201138,201139,201140,200733,200734,200734,200736,200737,200738,200739,200740,200741,
200742,200743,200001,200002,200003,200004,200005,200006,200101,200102,200007,200008,200009,200010,
200011,200012,200296,200297,200744,200289,200290,200298,200299,200300,200291,200292,200099,200555,
200293,200294,200295,200145,200146,200147,200148,200149,200150,200151,200152,200153,200154,200155,
200156,200661,200062,200104,200105,200169,200170,200171,200172,200173,200175,200174,200176,200177,
200178,200179,200180,201067,201068,201010,201057,201058,201059,201060,201061,201062,201063,201064,
201065,201066,201141,200106,200107,200108,200619,200622,200965,200373,201142,201143,201146,200109,
201144,201145,200556,200557,200902,200903,200904,200905,200906,200908,200909,200910,200911,200912,
201069,201070,201071,201072,200625,200626,200627,200628,201073,201074,201075,200629,200630,200634,
200635,200631,200632,200949,200633,200636,200950,200952,200955,200956,200959,200960,200951,200953,
200954,200957,200958,200095,200096,200086,200091,200093,200094,200085,200087,200098,200090,200089,
200092,200229,200230,200231,200232,200233,200234,200235,200236,200237,200238,200239,200240,200025,
200026,200027,200028,200029,200030,200031,200034,200032,200033,200035,200036,200925,200926,200927,
200928,200929,200931,200932,200933,200930,200934,200935,200936,200049,200050,200051,200052,200053,
200054,200055,200056,200057,200058,200059,200060,200121,200122,200123,200124,200125,200126,200127,
200128,200129,200130,200131,200132,200157,200158,200159,200160,200161,200162,200163,200164,200165,
200166,200167,200168,200193,200194,200195,200196,200197,200198,200577,200587,200579,200578,200580,
200581,200582,200583,200584,200585,200586,200588,200313,200314,200315,200316,200317,200318,200319,
200320,200321,200322,200323,200324,200409,200410,200411,200412,200413,200414,200415,200416,200417,
200558,200418,200419,200420,200907,200419,200637,200638,200639,200640,200641,200642,200643,200644,
200646,200647,200648,200697,200698,200699,200645,200700,200701,200702,200703,200704,200705,200706,
200707,200708,200469,200470,200471,200472,200473,200474,200475,200476,200477,200478,200479,200480,
200109,200199,200200,200201,200202,200203,200204,200110,200111,200112,200113,200114,201117,201118,
201119,201121,201120,201122,201123,201124,201125,201126,201127,201128,200529,200530,200531,200532,
200533,200534,200540,201081,200535,200536,200537,200538,200539,201082,201083,201084,201085,201086,
201087,201088,201089,201090,201091,201092,200913,200914,200917,200918,200915,200916,200919,200920,
200921,200922,200923,200924,200277,200278,200279,200115,200280,200281,200282,200283,200284,200998,
200285,201076,201077,201078,201079,200286,200241,200242,200243,200244,200245,200246,200247,200248,
200249,200250,200251,200252,201080,200287,200288,200868,200869,200870,200871,200872,200873,200874,
200875,200997,200375,200376,200876,200685,200686,200116,200687,200688,200689,200690,200691,200692,
200693,200694,200695,200696,200445,200446,200447,200448,200449,200450,200451,200452,200117,200453,
200454,200455,200217,200218,200219,200220,200221,200222,200223,200224,200456,200454,200118,200119,
200120,200225,200226,200227,200385,200386,200228,200387,200388,200454,200389,200390,200391,200392,
200393,200394,200395,200396,200505,200506,200507,200508,200509,200510,200511,200512,200513,200514,
200892,200515,200516,200709,200710,200711,200712,201000,200713,200714,200715,200716,200717,200718,
200719,200720,200376,200671,200541,200542,200543,200544,200545,200546,200547,200548,200549,200307,
200550,200551,200552,200649,200650,200651,200652,200653,200654,200655,200656,200657,200279,200658,
200659,200998,200660,200037,200038,200039,200040,200041,200042,200043,200044,200045,200046,200047,
200048,200253,200254,200255,200256,200257,200258,200259,200260,200261,200262,200263,200264,200337,
200338,200339,200340,200341,200342,200343,200344,200345,200346,200347,200348,200841,200842,200843,
200844,200845,200846,200847,200848,200849,200850,200851,200852,200433,200434,200435,200436,200437,
200438,200439,200440,200441,200442,200443,200444,200985,200986,200987,200988,200989,200990,200991,
200992,200993,200994,200995,200073,200074,200996,200075,200076,200077,200078,200079,200080,200081,
200082,200083,200084,200805,200806,200807,200808,200809,200810,200811,200812,200813,200814,200815,
200816,200721,200722,200723,200724,200725,200723,200724,200727,200730,200731,200726,200732,201093,
201094,201095,201096,201097,201098,201099,201100,201101,201102,201103,201104,200565,200566,200567,
200568,200569,200570,200571,200572,200573,200574,200575,200576,200265,200266,200267,200268,200269,
200270,200271,200272,200273,200274,200275,200276,200325,200326,200327,200328,200329,200330,200331,
200332,200333,200334,200335,200336,201105,201106,201107,201108,201109,201110,201111,201112,201113,
201114,201115,201116,200817,200818,200819,200820,200821,200822,200823,200824,200825,200826,200827,
200828,200457,200458,200459,200460,200461,200462,200463,200464,200465,200466,200467,200468,180940,
180932,180936,180995,180801,180308,180615,180606,180611,180614,16070492,180460,221104,221105,220025,
220026,220027,220028,220029,220030,220031,220033,220034,220035,220036,220325,220326,220327,220328,
220329,220330,220331,220332,220333,220334,220335,220336,220817,220818,220819,220820,220821,220822,
220823,220824,220825,220827,220828,220926,220927,220928,220929,220461,220931,220932,220032,220933,
220934,220935,220936,220409,220410,220411,220412,220413,220414,220415,220416,220417,220418,220419,
220420,220133,220134,220135,220136,220138,220139,220140,220141,220142,220143,220144,220145,220146,
220147,220148,220149,220150,220151,220152,220153,220154,220155,220156,220999,221000,221001,220997,
220998,221002,221003,221004,221005,221006,221007,220253,220254,220255,220256,220257,220258,220259,
220260,221008,220261,220262,220263,220264,200205,220206,220207,17071720,17072537,220208,220209,
220210,220211,220212,220213,220214,220215,220216,220037,220038,220039,220040,220041,220042,220043,
220044,220045,220046,220241,220242,220243,220244,220245,220047,220246,220247,220048,220248,220249,
220250,220251,220252,220277,220278,220279,220280,220281,220283,220284,220282,220001,220002,220003,
220004,220005,220006,220285,220286,220007,220008,220009,220010,220011,220012,220287,220288,220193,
220194,220195,220196,220197,220198,220199,220200,220201,220202,220203,220204,220433,220434,220435,
220436,220437,220438,220439,220440,220441,220442,220443,220444,220169,220170,220171,220172,220173,
220174,220175,220176,220177,220178,220179,220180,220181,220182,220183,220184,220185,220186,220187,
220188,220189,220190,220191,220192,220469,220470,220471,220472,220473,220474,220475,220476,220477,
220478,220479,220480,220109,220110,220111,220112,220113,220114,220115,220116,220117,220118,220119,
220120,220961,220962,220963,220964,220965,220966,220967,220968,220969,220970,220971,220972,220805,
220806,220807,220808,220809,220810,220811,220812,220813,220814,220815,220816,220721,220722,220723,
220724,220725,220726,220727,220728,220729,220730,220731,220732,220457,220458,220459,220460,220461,
220462,220463,220464,220465,220466,220467,220468,220049,220050,220051,220052,220053,220054,220055,
220056,220057,220058,220059,220060,220373,220374,220375,220376,220377,220378,220379,220380,220381,
220382,220383,220384,220865,220866,220867,220868,220869,220870,220871,220872,220873,220985,220986,
220987,220874,220875,220876,220745,220746,220747,220748,220750,220749,220751,220752,220753,220754,
220755,220756,220529,220530,220531,220532,220533,220534,220535,220536,220537,220538,220539,220540,
220157,220158,220159,220160,220161,220162,220163,220164,220165,220877,220878,220879,220880,220166,
220167,220168,220881,220882,220883,220884,220885,220886,220887,220888,220445,220446,220447,220448,
220449,220450,220451,220452,220453,220454,220455,220456,220181,220182,220183,220184,220185,220186,
220187,220188,220189,220190,220191,220192,220757,220758,220759,220702,220700,220762,220763,220764,
220765,220766,220767,220768,220349,220350,220351,220352,220353,220354,220355,220356,220357,220358,
220359,220360,220073,220074,220075,220076,220077,220078,220079,220080,220081,220082,220083,220084,
221069,221070,221071,221072,220081,221073,221074,220075,220076,220077,220078,220079,220080,220361,
220362,220363,220364,220365,220366,220367,220368,220369,220370,220371,220372,220337,220338,220339,
220340,220341,220342,220343,220344,220345,220346,220347,220384,220301,220303,220304,220305,220306,
220307,220308,220601,220602,220603,220604,220605,220606,220607,220608,220609,220610,220309,220310,
220311,220312,220611,220612,220217,220218,220219,220220,220221,220222,220223,220224,220225,220226,
220227,220228,220709,220710,220711,220712,220713,220714,220715,220716,220717,220718,220719,220733,
220734,220735,220736,220737,220738,220720,220739,220740,220741,220742,220743,220744,221093,221094,
221095,221096,221097,221098,221099,221100,221101,221102,221103,220541,220542,220543,220544,220545,
220546,220547,220548,220549,220550,220551,220552,220313,220314,220315,220316,220317,220318,220319,
220320,220321,220322,220323,220324,220121,220122,220123,220124,220125,220126,220127,220128,220129,
220130,220131,220132,221009,221010,221011,221012,221013,221014,221015,221016,221017,221018,221019,
221020,220613,220614,220615,220616,220617,220618,220619,220620,220621,220622,220623,220624,220565,
220566,220567,220568,220569,220570,220571,220572,220573,220574,220575,220576,220793,220794,220795,
220796,220797,220799,220800,220798,220801,220802,220803,220804,220829,220830,220831,220832,220833,
220836,220834,220835,220837,220838,220839,220097,220098,220840,220099,220100,220101,220102,220103,
220104,220105,220106,220107,220108,220421,220422,220424,220425,220426,220428,220423,220427,220429,
220430,220431,220432,220988,220989,220990,220991,220992,220993,220994,220995,220996,220649,220650,
220651,220652,220653,220654,220655,220656,220657,220658,220659,220660,220685,220686,220687,220688,
220689,220690,220691,220692,220693,220694,220589,220590,220591,220592,220593,220594,220595,220596,
220597,220598,220695,220696,220625,220626,220627,220628,220629,220630,220631,220632,220633,220634,
220635,220636,220599,220600,220013,220014,220015,220016,220017,220018,220019,220020,220021,220022,
220023,220024,220889,220890,220891,220892,220893,220894,220895,220896,220023,220024,220897,220898,
220899,220900,220949,220950,220951,220952,220953,220826,220954,220955,220956,220957,220958,220959,
220960,220781,220924,220782,220363,220783,220784,220785,220786,220787,220788,220789,220790,220791,
220792,221021,221022,221023,221024,221025,221026,221027,221028,221029,221030,221031,221032,220554,
220553,220555,220556,220557,220558,220559,220560,220561,220562,220563,220564,220481

製造販売業者の名称　： 株式会社カブラギ医療商事
製造販売業者の所在地： 東京都練馬区桜台３‐７‐３　カブラギビル
許可の種類　　　　　： 第三種医療機器製造販売業
許可番号　　　　　　： 13B2X10144
製造業者の名称：BESMED HEALTH BUSINESS CORP.
輸入先国名：台湾

当該製品は管理医療機器及び特定保守管理医療機器に分類されますが、管理医療機器及び特定保守管理機器の表
示が機器本体に記載されていなかった事が判明いたしました。したがってラベルの貼付を行う自主改修を実施し
ます。

本件は、機器本体に「特定保守管理機器」等の表示がされていなかったことによるもので、製品の品質、有効
性、安全性に影響を及ぼすものではなく、健康被害が発生する可能性はないものと判断します。なお、これま
でに、本事象による健康被害の報告は受けておりません。

平成26年11月4日

温熱効果

納入しました販売店、及び顧客先はすべて把握しておりますので、これまで出荷した全ての製品について、改修
を実施します。

担当者　：　鏑木康二
連絡先　： 東京都練馬区桜台3-7-3　株式会社カブラギ医療商事　品質保証部
電話番号： 03-3948-0196
FAX番号 ： 03-3948-0199