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令和 3年12月21日作成
一般的名称及び販売名
一般的名称： (1)〜(3)据置型デジタル式汎用X 線透視診断装置,(4)据置型診断用X線発生装置 販売名 ： (1)X線テレビシステム SONIALVISION G4 (2)X線テレビシステム SONIALVISION safire17 (3)X線テレビシステム FLEXAVISION (4)診断用Ｘ線高電圧装置 UD150B-40
対象ロット、数量及び出荷時期
(1)X線テレビシステム SONIALVISION G4 製造番号：41C35012A001,41C350137001,41C350137002,41C350139001,41C35013B001,41C35013B002,41C350141001 41C350141002,41C350142001,41C350143001,41C350143002,41C350146001,41C350148001,41C350149001 41C350149002,41C350149003,41C35014A001,41C350152001,41C350153002,41C350153003,41C350153004 41C350154001,41C350154002,41C350158001,41C350159001,41C35015B001,41C35015C001,41C35015C002 41C35015C003,41C350161001,41C350161002,41C350162001,41C350162002,41C350163001,41C350163002 41C350163003,41C350163004,41C350163005,41C350164001,41C350164002,41C350165001,41C350165002 41C350167001,41C350169001,41C35016A001,41C35016C001,41C35016C002,41C350172001,41C350172002 41C350172003,41C350173001,41C350173002,41C350174001,41C350175001,41C350176001,41C350179001 41C35017C001,41C350232001,41C350232002,41C350232003,41C350233001,41C350233002,41C350233003 41C350233004,41C350233005,41C350233006,41C350233007,41C350233008,41C350234002,41C350234003 41C350234004,41C350234005,41C350234006,41C350235001,41C350235002,41C350236001,41C350236002 41C350236003,41C350236004,41C350236005,41C350236006,41C350237001,41C350237002,41C350237003 41C350238001,41C350238002,41C350238003,41C350238004,41C350238005,41C350238006,41C350238007 41C350239001,41C350239002,41C350239003,41C350239004,41C350239005,41C350239006,41C35023A001 41C35023A002,41C35023A003,41C35023A004,41C35023A005,41C35023A006,41C35023A007,41C35023B001 41C35023B002,41C35023B003,41C35023B004,41C35023B005,41C35023B006,41C35023B007,41C35023C001 41C35023C002,41C35023C003,41C35023C004,41C35023C005,41C35023C006,41C35023C007,41C350241001 41C350241002,41C350241003,41C350241004,41C350241005,41C350241006,41C350241007,41C350242001 41C350242002,41C350242003,41C350242004,41C350242005,41C350242006,41C350242007,41C350243001 41C350243002,41C350243003,41C350243004,41C350243005,41C350244001,41C350244002,41C350246001 41C350246002,41C350246003,41C350246004,41C350246005,41C350247001,41C350248001,41C350248002 41C350248003,41C350248004,41C350248005,41C350248006,41C350249001,41C350249002,41C350249003 41C350249004,41C35024A001,41C35024A002,41C35024B001,41C35024B002,41C35024B003,41C35024B004 41C35024C001,41C35024C002,41C35024C003,41C35024C004,41C35024C005,41C35024C006,41C35024C007 41C35024C008,41C35024C009,41C350251001,41C350251002,41C350251003,41C350251004,41C350251005 41C350251006,41C350251007,41C350252001,41C350252002,41C350252003,41C350252004,41C350252005 41C350252006,41C350252007,41C350252008,41C350252009,41C350252010,41C350252011,41C350253001 41C350253002,41C350253003,41C350253004,41C350253005,41C350253007,41C350253008,41C350253009 41C350253010,41C350254001,41C350254002,41C350254003,41C350254004,41C350254005,41C350255001 41C350255002,41C350256001,41C350256002,41C350256003,41C350256004,41C350257001,41C350257002 41C350257003,41C350257004,41C350258001,41C350258002,41C350259001,41C35025A001,41C35025A002 41C35025B001,41C35025B002,41C35025B003,41C35025B004,41C35025B005,41C35025B006,41C35025C001 41C350261001,41C350261002,41C350261003,41C350262001,41C350262002,41C350262003,41C350262004 41C350262005,41C350262006,41C350262007,41C350262008,41C350262009,41C350262010,41C350263001 41C350263002,41C350263003,41C350263005,41C350263006,41C350263007,41C350263008,41C350264001 41C350264002,41C350265001,41C350265002,41C350265003,41C350266001,41C350267001,41C350267002 41C350267003,41C350267004,41C350267005,41C350267006,41C350267007,41C350268001,41C350268002 41C350268003,41C350268004,41C350269001,41C350269002,41C350269003,41C350269004,41C35026B001 41C35026B002,41C35026C001,41C35026C002,41C35026C003,41C35026C004,41C35026C005,41C350271001 41C350271002,41C350271003,41C350271004,41C350272001,41C350272002,41C350273001,41C350274001 41C350275001,41C350275002,41C350275003,41C350276001,41C350277001,41C350278001,41C350279001 41C35027A001,41C35027B001,41C35027B002,41C35027B003,41C350284001,41C35028A001,41C350292001 41C350298001,41C3502B2001,41C350358001,41C350361001,41C350362001,41C350362002,41C350365001 41C350367001,41C350369001,41C350372001,41C350372002,41C350378001,41C350558001,41C350558002 41C350558003,41C350558004,41C350559001,41C350559002,41C35055A001,41C35055A002,41C35055A003 41C35055A004,41C35055B001,41C35055B002,41C350561001,41C350561002,41C350561003,41C350561004 41C350561005,41C350561006,41C350562001,41C350562002,41C350562003,41C350562004,41C350563001 41C350563002,41C350564001,41C350564002,41C350564003,41C350564004,41C350565001,41C350565002 41C350566001,41C350567001,41C350567002,41C350569001,41C350569002,41C350569003,41C350569004 41C350569005,41C350569006,41C350569007,41C350569008,41C35056A001,41C35056A002,41C35056B001 41C35056B002,41C35056C001,41C35056C002,41C350571001,41C350571002,41C350571003,41C350571004 41C350572001,41C350572002,41C350572003,41C350572004,41C350572005,41C350573001,41C350573002 41C350574001,41C350575001,41C350578001,41C35057C001,41C350675001,41C350677001,41C350678001 41C350679001,41C350679002,41C35067C001,41C350681001,41C350681002,41C350682001,41C350682002 41C350682003,41C350684001,41C350684002,41C350685001,41C350686001,41C350687001,41C350688001 41C35068A001,41C35068A002,41C35068A003,41C35068B001,41C35068B002,41C35068B003,41C35068C001 41C350691001,41C350693001,41C350693002,41C350695001,41C350697001,41C350697002,41C350697003 41C350698001,41C350698002,41C35069B001,41C35069C001,41C3506A1001,41C350773001,41C350773002 41C350773003,41C350776001,41C350778001,41C350779001,41C350779002,41C35077A001,41C35077A002 41C35077B001,41C35077B002,41C35077C001,41C35077C002,41C35077C003,41C350781001,41C350781002 41C350782001,41C350782002,41C350782003,41C350782004,41C350782005,41C350782006,41C350782007 41C350782008,41C350783001,41C350783002,41C350784001,41C350784002,41C350785001,41C350786001 41C350787001,41C350787002,41C350788001,41C350788002,41C350788003,41C350788004,41C350789001 41C350789002,41C350789003,41C350789004,41C350789005,41C350789006,41C35078A001,41C35078A002 41C35078A003,41C35078A004,41C35078B001,41C35078B002,41C35078B003,41C35078B004,41C35078B005 41C35078B006,41C35078B007,41C35078C001,41C35078C002,41C35078C003,41C35078C004,41C35078C005 41C35078C006,41C35078C007,41C350791001,41C350791002,41C350791003,41C350792001,41C350792002 41C350792003,41C350792004,41C350793001,41C350793002,41C350793003,41C350793004,41C350794001 41C350794002,41C350795001,41C350795003,41C350795004,41C350795005,41C350795006,41C350795007 41C350796001,41C350797001,41C350797002,41C350797003,41C350797004,41C350798001,41C350798002 41C350798003,41C350798004,41C350798005,41C350798006,41C350798007,41C350799001,41C350799002 41C350799003,41C35079B001,41C350875001,41C350877001,41C350879001,41C350879002,41C35087A001 41C35087A002,41C35087B001,41C35087B002,41C35087B003,41C35087C001,41C350881001,41C350881002 41C350881003,41C350882001,41C350882002,41C350882003,41C350882004,41C350882005,41C350882006 41C350883001,41C350883002,41C350883003,41C350884002,41C350885001,41C350886001,41C350886002 41C350886003,41C350886004,41C350887001,41C350888001,41C350889001,41C350889002,41C35088A001 41C35088A002,41C35088C001,41C350891001,41C350891002,41C350891003,41C350892001,41C350892002 41C350892003,41C350892004,41C350894001,41C350895001,41C350895002,41C350895003,41C350896001 41C350897001,41C350897002,41C350897003,41C350898001,41C350898002,41C350899002,41C35089B001 41C35089B002,41C35089C001,41C35089C002,41C3508A1001,41C3508A1002,41C3508A1003,41C3508A1004 41C3508A2002,41C3508A4001,41C3508A5001,41C3508A6001,41C3508A7001,41C3508A9001,41C3508AC001 41C3508B1001,41C3508B1002,41C3508B2001,41C3508B2002,41C3508B2003,41C3508B3001,41C3508B5001 41C3508B8001,41C351C96001,41C351CA2001,41C351CAC001,41C351CB2001,41C351CB4001,41C351D94001 41C351D98001,41C351DA4001,41C351DB3001,41C351DB3002,41C3526A1001,41C3526B2001,41C3526B2002 41C3526B3001,41C353D9A001,41C353D9A002,41C353D9A003,41C353D9B001,41C353D9C001,41C353D9C002 41C353D9C003,41C353D9C004,41C353D9C005,41C353DA1001,41C353DA1002,41C353DA1003,41C353DA1004 41C353DA1005,41C353DA2001,41C353DA2002,41C353DA2003,41C353DA2004,41C353DA2005,41C353DA2006 41C353DA2007,41C353DA2008,41C353DA3001,41C353DA3002,41C353DA3003,41C353DA3004,41C353DA3005 41C353DA4001,41C353DA4002,41C353DA4003,41C353DA5001,41C353DA6001,41C353DA7001,41C353DA7002 41C353DA8001,41C353DA9001,41C353DA9002,41C353DA9003,41C353DA9004,41C353DA9005,41C353DAA001 41C353DAC001,41C353DAC002,41C353DAC003,41C353DB1001,41C353DB1002,41C353DB1003,41C353DB1004 41C353DB1005,41C353DB1006,41C353DB1007,41C353DB1008,41C353DB1009,41C353DB1010,41C353DB2001 41C353DB2002,41C353DB2003,41C353DB3001,41C353DB3002,41C353DB3004,41C353DB3005,41C353DB3006 41C353DB4001,41C353DB4002,41C353DB4003,41C353DB4004,41C353DB5002,41C353DB5003,41C353DB5004 41C353DB5005,41C353DB6001,41C353DB6002,41C353DB7001,41C353DB7002,41C353DB7003,41C353DB8002 41C355B9A001,41C355BB2001,41C355BB2002,41C355BB3001,41C355BB4001,41C355BB5001,41C355BB6001 製造時期：平成25年2月〜令和3年8月 出荷台数：672台 (2)X線テレビシステム SONIALVISION safire17 製造番号：081B797201,081B798301,081B804501,081C104001,081C118601,081G157701,081H736201,081R723001 081R723101,081S121401,091A016701,091B806201,091B819201,091B829901,091B830001,091B836701 091B851001,091B852401,091C118801,091C135501,091C140801,091C143701,091C145501,091C147701 091C165201,091F302201,091F313001,091F313101,091F320501,091H645201,091H739001,091H743901 091H744101,091H745801,091H745901,091H772301,091H779601,091K010701,091K243901,091K305401 091K877401,091K877901,091M266201,091M272901,091M282201,091M294101,091O680101,091O680201 091O681501,091S137301,101B855801,101B861901,101B869501,101B872501,101C011701,101C174001 101C177001,101C181201,101H008101,101K151101,101K154001,101K253001,101K308201,101K569501 101K725201,101K881201,101L696101,101M296301,101M302201,101O682801,101O682802,101O685101 101O686601,101O688401,101P087601,101Q705901,101Q708201,101Q709301,101R748401,101R750101 101S149401,41222F50B001,41222F511001,41222F512001,41222F514001,41222F521001,41222F618001 41222F61C001,41222F70A001,41222F70A002,41222F70B001,41222F70C001,41222F70C002,41222F70C003 41222F711001,41222F711002,41222F711003,41222F711004,41222F712001,41222F712002,41222F713001 41222F713002,41222F713003,41222F713004,41222F713005,41222F717001,41222F717002,41222F717003 41222F718001,41222F718002,41222F718003,41222F718004,41222F719001,41222F719002,41222F719004 41222F71A002.41222F71A003,41222F71B001,41222F71B002,41222F71B003,41222F71B004,41222F71C001 41222F71C002,41222F71C003,41222F71C004,41222F721001,41222F721002,41222F721003,41222F721004 41222F722001,41222F722002,41222F723001,41222F723002,41222F723003,41222F723006,41222F723007 41222F724001,41222F724002,41222F725001,41222F725002,41222F726001,41222F726002,41222F726003 41222F726004,41222F726005,41222F726006,41222F726007,41222F727001,41222F727002,41222F727003 41222F727004,41222F728001,41222F729001,41222F729002,41222F729003,41222F72A001,41222F72A002 41222F72A003,41222F72B001,41222F72B002,41222F72B003,41222F72C001,41222F731001,41222F731002 41222F731003,41222F732001,41222F732002,41222F732003,41222F732004,41222F733001,41222F733003 41222F733004,41222F734002,41222F734003,41222F735001,41222F737001,41222F737002,41222F737003 41222F739001,41222F739002,41222F73A001,41222F73A002,41222F73B001,41222F73B003,41222F73C002 41222F741001,41222F741002,41222F741003,41222F741004,41222F742001,41222F742002,41222F742003 41222F742004,41222F744001,41222F747001,41222F747002,41222F747003,41222F748001,41222F748003 41222F748004,41222F748005,41222F74B001,41222F74C001,41222F751001,41222F752001,41222F80B001 41222F80B002,41222F811001,41222F812001,41222F813001,41222F814001,41222F815001,41222F815002 41222F817001,41222F817002,41222F817003,41222F819001,41222F819002,41222F81B002,41222F81C001 41222F821001,41222F821002,41222F821003,41222F821004,41222F822001,41222F823001,41222F823002 41222F827001,41222F827002,41222F827003,41222F828001,41222F828002,41222F828003,41222F828004 41222F82A001,41222F82B001,41222F82B002,41222F82C001,41222F831001,41222F831002,41222F833001 41222F834001,41222F835001,41222F836001,41222F838001,41222F839001,41222F839002,41222F839003 41222F83C001,41222F842001,41222F842002,41222F844001,412230111001,412230113001,412230125001 412230131001,412230218001,412234327001 製造時期：平成20年9月〜平成27年3月 出荷台数：258台 (3)X線テレビシステム FLEXAVISION 製造番号：417A16D39001,417A16D4C001,417A16E22002,417A16E25001,417A16E25002,417A16E28001,417A16E29001 417A16E31001,417A16E32001,417A16E33002,417A16E33003,417A16E37001,417A16E37005,417A16E38001 417A16E39001,417A16E42002,417A16E43002,417A16E43003,417A16E52001,417A16E53001,417A16E54001 417A16F2A001,417A17029001,417A17721001,417A17724001,417A17724002,417A17725002,417A17729001 417A1772A001,417A17731001,417A17742002,417A17742003,417A17758001,417A17758002,417A17821002 417A17821003,417A17823002,417A17823003,417A17824001,417A17829003,417A1782A002,417A17831002 417A17832001,417A17832003,417A17832007,417A17838004,417A17839001,417A17839003,417A1783A002 417A1783C003,417A1783C009,417A17841001,417A17841002,417A17842003,417A17844001,417A17844002 417A17847001,417A17848003,417A1784B001,417A17852001,417A17853003,417A17854001,417A17854002 417A17922001,417A17947001,417A17959001,41E928C63002,41E928C63003,41E928C63004,41E928C63005 41E928C63006,41E928C67001,41E928C69001,41E928C69002,41E928C6B001,41E928C6B002,41E928C6C005 41E928C6C006,41E928C6C007,41E928C6C008,41E928C72001,41E928C73003,41E928C73004,41E928D5C001 41E928D64001,41E928D6A001,41E928E5B001,41E928E63003,41E928E63005,41E928E6B001,41E928E6C003 41E928E71001,41EF06C73001,41EF07073001,41EF07074001 製造時期：平成24年1月〜平成29年4月 出荷台数：95台 (4)診断用X線高電圧装置 UD150B-40 製造番号：0262R73905,0262R73906,0262R73910,0262R74106,0262R74108,0262R74109,0262R74408,0262R74808 0262R74904,0262R74906,0262R74908,0362R70109,0362R70201,0362R70707,0362R70708,0362R71003 0362R71004,0362R71007,0362R71103,0362R71310,0362R71602,0362R71806,0362R72002,0362R72303 0362R72401,0362R72405,0362R72501,0362R72506,0362R72606,0362R72810,0362R73607,0362R74506 0362R74509,0362R74510,0462R70107,0462R70204,0462R70208,0462R70308,0462R70408,0462R70510 0462R70903,0462R70905,0462R71601,0462R71809,0462R71810,0462R72105,0462R72106,0462R72108 0462R72203,0462R72307,0462R72309,0462R72310,0462R72410,0462R72704,0462R72706,0462R72805 0462R72807,0462R72808,0462R72910,0462R73008,0462R73303,0462R73305,0462R73504,0462R73602 0462R73603,0462R73610,0462R73704,0462R74901,0562R70209,0562R70303,0562R70305,0562R70310 0562R70410,0562R70610,0562R71601,0562R71801,0562R71802,0662R70704,0662R70803,3M5246917008 3M5246924001,3M5246929011,3M524694C005,3M5246956007 製造時期：平成18年6月〜平成27年6月 出荷台数：84台
製造販売業者等名称
製造販売業者の名称 ： 株式会社島津製作所 製造販売業者の所在地： 京都府京都市中京区西ノ京桑原町1番地 許可の種類 ： 第一種医療機器製造販売業 許可番号 ： 26B1X00003
改修理由
当該の医療機器において、調整基準の問題により特定の透視撮影条件で使用した場合に、被検者に照射されるX 線が医療法施行規則で規定される線量率を超える可能性があることが判明しました。 そのため、適切な基準での再調整を自主改修として実施します。
危惧される具体的な健康被害
当該事象は一部のプロトコルで体厚が厚い場合等、X線出力が大きい場合で発生する可能性があります。 被ばく総量は線量率と透視積算時間の積であるため、線量率が規定値を超える様な場合でも、透視タイマーにて 透視積算時間を管理・制限しているため、重篤な健康被害が発生する被ばく総量となる可能性はないと判断して います。 なお、健康被害についての報告は受けておりません。
改修開始年月日
令和3年12月21日
効能・効果又は用途等
(1)透視・撮影を目的とし、人体を透過したX 線の電離作用を利用して人体画像情報を診断のために提供します。 また、X線パターンをX線平面検出器で撮像し、コンピュータ処理した画像情報を診療のために提供します。 (2)透視撮影を目的とし，人体を透過したＸ線をＸ線平面検出器で撮像し、人体の画像情報を診療のために提供し ます。 (3)透視撮影を目的とし、人体を透過したＸ線の蛍光作用、写真作用又は電離作用を利用して人体画像情報を診断 のために提供します。 (4)Ｘ線管装置に対してＸ線出力に必要な電力を供給し、かつ、それを制御します（治療に使用することを除 く）。
その他
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。
担当者及び連絡先
担当者 ： 谷川 勝哉、山本 武史 連絡先 ： 株式会社島津製作所 メディカル規制統括部 安全管理グループ 電話番号： 075-823-1928 FAX番号 ： 075-823-2530