令和 5年 5月16日作成
令和 5年 5月25日訂正(*)

一般的名称： 混合ガス麻酔器
販売名　　： セデント サイコリッチT-70

対象台数　1,497台
出荷時期　平成27年3月20日〜令和5年5月9日(*)
対象機器番号(*)
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#N02213,#N02215,#N02216,#N02223,#N02224,#N02225,#N02228,#N02229,#N02231,#N02235,#N02237,#N02238
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#N02259,#N02260,#N02261,#N02263,#N02264,#N02265,#N02268,#N02269,#N02274,#N02278,#N02290,#N02291
#N02292,#N02298,#N02302,#N02303,#N02305,#N02306,#N02310,#N02311,#N02312,#N02313,#N02315,#N02316
#N02318,#N02324,#N02326,#N02327,#N02328,#N02333,#N02334,#N02336,#N02357,#N02358,#N02359,#N02360
#N02361,#N02362,#N02363,#N02365,#N02371,#N02375,#N02376,#N02377,#N02378,#N02386,#N02387,#N02392
#N02393,#N02397,#N02398,#N02399,#N02400,#N02401,#N02402,#N02404,#N02405,#N02406,#N02407,#N02410
#N02413,#N02415,#N02418,#N02424,#N02434,#N02437,#N02442,#N02445,#N02447,#N02448,#N02449,#N02450
#N02451,#N02453,#N02454,#N02455,#N02457,#N02460,#N02468,#N02469,#N02470,#N02473,#N02474,#N02476
#N02477,#N02478,#N02479,#N02482,#N02500,#N02501,#N02502,#N02503,#N02506,#N02508,#N02509,#N02510
#N02516,#N02519,#N02525,#N02527,#N02540,#N02541,#N02543,#N02544,#N02545,#N02552,#N02553,#N02554
#N02555,#N02558,#N02559,#N02561,#N02563,#N02564,#N02567,#N02568,#N02569,#N02571,#N02574,#N02577
#N02580,#N02587,#N02588,#N02591,#N02592,#N02593,#N02595,#N02597,#N02601,#N02603,#N02612,#N02614
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#N02672,#N02689,#N02690,#N02691,#N02700,#N02701,#N02705,#N02712,#N02714,#N02715,#N02719,#N02723
#N02725,#N02728,#N02731,#N02734,#N02736,#N02738,#N02744,#N02745,#N02754,#N02756,#N02757,#N02767
#N02773,#N02775,#N02779,#N02785,#N02789,#N02790,#N02791,#N02794,#N02795,#N02796,#N02797,#N02800
#N02801,#N02804,#N02806,#N02807,#N02808,#N02809,#N02813,#N02814,#N02819,#N02821,#N02853,#N02856
#N02857,#N02860,#N02863,#N02896,#N02897,#N02898,#N02899,#N02901,#N02902,#N02903,#N02904,#N02905
#N02906,#N02908,#N02909,#N02910,#N02913,#N02914,#N02917,#N02918,#N02919,#N02920,#N02921,#N02922
#N02923,#N02925,#N02926,#N02927,#N02928,#N02929,#N02930,#N02932,#N02942,#N02943,#N02944,#N02945
#N02946,#N02949,#N02951,#N02952,#N02953,#N02954,#N02955,#N02956,#N02957,#N02958,#N02960,#N02962
#N02963,#N02964,#N02970,#N02971,#N02974,#N02979,#N02986,#N02990,#N02991,#N02992,#N02993,#N02994
#N02995,#N02996,#N02997,#N02998,#N03000,#N03001,#N03002,#N03003,#N03004,#N03005,#N03012,#N03014
#N03015,#N03016,#N03020,#N03027,#N03030,#N03033,#N03034,#N03035,#N03036,#N03037,#N03042,#N03043
#N03076,#N03079,#N03080,#N03081,#N03082,#N03083,#N03084,#N03085,#N03087,#N03088,#N03091,#N03092
#N03093,#N03094,#N03133,#N03135,#N03136,#N03139,#N03145,#N03146,#N03153,#N03160,#N03162,#N03163
#N03164,#N03165,#N03166,#N03167,#N03168,#N03169,#N03170,#N03171,#N03192,#N03193,#N03197,#N03200
#N03202,#N03203,#N03210,#N03227,#N03232,#N03233,#N03235,#N03236,#N03237,#N03254,#N03255,#N03256
#N03257,#N03260,#N03284,#N03291,#N03292,#N03293,#N03294,#N03295,#N03309,#N03310,#N03313,#N03323
#N03324,#N03334,#N03337,#N03338,#N03339,#N03340,#N03349,#N03352,#N03359,#N03361,#N03363,#N03375
#N03376,#N03377,#N03378,#N03380,#N03381,#N03382,#N03383,#N03385,#N03386,#N03389,#N03416,#N03417
#N03418,#N03419,#N03425,#N03428,#N03429,#N03431,#N03451,#N03453,#N03454,#N03455,#N03457,#N03458
#N03463,#N03464,#N03466,#N03467,#N03469,#N03470,#N03473,#N03474,#N03476,#N03477,#N03478,#N03488
#N03489,#N03495,#N03497,#N03498,#N03502,#N03504,#N03505,#N03510,#N03511,#N03515,#N03520,#N03521
#N03522,#N03523,#N03526,#N03528,#N03542,#N03543,#N03544,#N03545,#N03546,#N03548,#N03552,#N03553
#N03559,#N03560,#N03574,#N03575,#N03577,#N03578,#N03582,#N03584,#N03585,#N03586,#N03587,#N03590
#N03593,#N03594,#N03596,#N03598,#N03599,#N03600,#N03612,#N03613,#N03614,#N03616,#N03617,#N03618
#N03622,#N03623,#N03627,#N03630,#N03631,#N03633,#N03635,#N03637,#N03638,#N03639,#N03640,#N03641
#N03643,#N03649,#N03651,#N03658,#N03659,#N03662,#N03663,#N03665,#N03684,#N03685,#N03687,#N03688
#N03689,#N03690,#N03691,#N03692,#N03693,#N03694,#N03701,#N03712,#N03714,#N03715,#N03724,#N03725
#N03726,#N03727,#N03728,#N03731,#N03732,#N03733,#N03734,#N03736,#N03737,#N03738,#N03739,#N03741
#N03744,#N03749,#N03758,#N03760,#N03763,#N03766,#N03768,#N03769,#N03771,#N03781,#N03801,#N03803
#N03817,#N03819,#N03853,#N03857,#N03858,#N03865,#N03866,#N03888,#N03901,#N03902,#N03904,#N03905
#N03912,#N03918,#N03926,#N03928,#N03941,#N03942,#N03944,#N03945,#N03955,#N03956,#N03957,#N03958
#N03962,#N03969,#N03980,#N03983,#N03987,#N03988,#N03989,#N03990,#N04006,#N04010,#N04011,#N04013
#N04014,#N04015,#N04016,#N04022,#N04023,#N04024,#N04027,#N04029,#N04031,#N04032,#N04033,#N04034
#N04044,#N04045,#N04046,#N04049,#N04051,#N04063,#N04064,#N04067,#N04068,#N04070,#N04073,#N04081
#N04085,#N04089,#N04090,#N04095,#N04101,#N04102,#N04105,#N04120,#N04122,#N04124,#N04125,#N04152
#N04153,#N04154,#N04167,#N04168,#N04171,#N04173,#N04174,#N04175,#N04186,#N04188,#N04189,#N04191
#N04192,#N04213,#N04214,#N04216,#N04217,#N04219,#N04221,#N04259,#N04260,#N04262,#N04266,#N04267
#N04268,#N04270,#N04271,#N04277,#N04282,#N04283,#N04284,#N04285,#N04286,#N04287,#N04288,#N04289
#N04290,#N04292,#N04293,#N04294,#N04295,#N04296,#N04307,#N04310,#N04311,#N04313,#N04318,#N04320
#N04321,#N04322,#N04323,#N04327,#N04333,#N04343,#N04344,#N04349,#N04350,#N04354,#N04355,#N04356
#N04357,#N04361,#N04362,#N04364,#N04365,#N04367,#N04369,#N04373,#N04381,#N04388,#N04389,#N04390
#N04391,#N04392,#N04410,#N04412,#N04420,#N04429,#N04430,#N04433,#N04435,#N04449,#N04450,#N04451
#N04464,#N04477,#N04484,#N04498,#N04500,#N04504,#N04505,#N04525,#N04528,#N04529,#N04541,#N04542
#N04543,#N04549,#N04550,#N04551,#N04552,#N04553,#N04555,#N04556,#N04558,#N04559,#N04560,#N04561
#N04563,#N04573,#N04574,#N04584,#N04588,#N04589,#N04590,#N04599,#N04600,#N04601,#N04616,#N04617
#N04630,#N04631,#N04632,#N04633,#N04634,#N04635,#N04649,#N04656,#N04672,#N04673,#N04674,#N04676
#N04677,#N04678,#N04679,#N04682,#N04683,#N04689,#N04694,#N04707,#N04708,#N04709,#N04714,#N04717
#N04718,#N04720,#N04721,#N04722,#N04749,#N04753,#N04755,#N04759,#N04767,#N04769,#N04771,#N04772
#N04774,#N04775,#N04776,#N04786,#N04788,#N04793,#N04798,#N04803,#N04805,#N04817,#N04823,#N04824
#N04828,#N04829,#N04830,#N04832,#N04833,#N04836,#N04839,#N04840,#N04841,#N04842,#N04843,#N04848
#N04849,#N04864,#N04866,#N04867,#N04869,#N04888,#N04890,#N04903,#N04907,#N04908,#N04909,#N04910
#N04911,#N04914,#N04920,#N04925,#N04927,#N04936,#N04937,#N04938,#N04952,#N04953,#N04955,#N04963
#N04964,#N04965,#N04966,#N04967,#N04968,#N04977,#N04990,#N04991,#N04995,#N04996,#N04998,#N05003
#N05008,#N05052,#N05053,#N05057,#N05060,#N05062,#N05069,#N05071,#N05076,#N05078,#N05079,#N05082
#N05083,#N05098,#N05099,#N05100,#N05101,#N05113,#N05114,#N05117,#N05118,#N05125,#N05135,#N05143
#N05153,#N05154,#N05156,#N05161,#N05164,#N05165,#N05172,#N05173,#N05189

製造販売業者の名称　： 株式会社セキムラ
製造販売業者の所在地： 東京都板橋区志村1‐28‐1
許可の種類　　　　　： 第一種医療機器製造販売業
許可番号　　　　　　： 13B1X00140

　今般、独立行政法人医療機器機構より、当該製品に係る平成２６年１１月２６日付け軽微変更届（セデントサ
イコリッチ Ｔ‐７０の原材料変更）については、軽微変更ではなく、承認事項一部変更承認申請に該当する変
更であるとのご指摘 がございました。当該製品に係る軽微変更届が不適切であったことから承認事項からの逸
脱が発生するため、該当する変更後ロットの製品の構成品である鼻マスクとISカニューレについて歯科診療及び
産婦人科診療を行う医療機関から自主回収致します。(*)

　当該軽微変更届時に、変更後の製品に関する安全性については確認済みであり、当該変更により重篤な健康被
害が発生する可能性はないと考えられます。なお、現在までに本事象に起因する重篤な健康被害は報告されてお
りません。

令和5年5月16日

　酸素と笑気（亜酸化窒素）の混合ガスを投与する麻酔器で、主に歯科診療時の笑気吸入鎮静法による鎮静や疼
痛緩和、または産婦人科診療における無痛分娩の際の疼痛緩和を目的とする。

　対象ロットの製品の出荷先／販売先は全て特定できており、文書による通知のうえ速やかに回収を実施致しま
す。

担当者　： 木村　久美子
連絡先　： 東京都板橋区志村1-28-1
電話番号： 03-3966-7736
FAX番号 ： 03-3966-4461