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令和 4年2月7日作成
一般的名称及び販売名
一般的名称： 据置型デジタル式汎用X 線透視診断装置 販売名 ： X線テレビシステム SONIALVISION G4
対象ロット、数量及び出荷時期
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 41C3508B7001,41C3508B8001,41C3508B8002,41C3508B8003,41C351C96001,41C351CA2001,41C351CAC001 41C351CB2001,41C351CB4001,41C351D94001,41C351D98001,41C351DA4001,41C351DB3001,41C351DB3002 41C351DB8001,41C3526A1001,41C3526B2001,41C3526B2002,41C3526B3001,41C3526B9001,41C353D9A001 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 41C353DB3001,41C353DB3002,41C353DB3003,41C353DB3004,41C353DB3005,41C353DB3006,41C353DB4001 41C353DB4002,41C353DB4003,41C353DB4004,41C353DB5001,41C353DB5002,41C353DB5003,41C353DB5004 41C353DB5005,41C353DB6001,41C353DB6002,41C353DB7001,41C353DB7002,41C353DB7003,41C353DB8001 41C353DB8002,41C353DB8003,41C353DB9001,41C355B9A001,41C355BB2001,41C355BB2002,41C355BB3001 41C355BB4001,41C355BB5001,41C355BB6001,41C355BB8001 製造時期：平成25年2月〜令和3年9月 出荷台数：683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 ： 26B1X0000
改修理由
特定の操作を行った場合に、以下の問題が発生する可能性があることが、社内で仕様変更を検討した際に判明し ました。 (1)パルス透視のX線照射レート（パルスレート）が設定値と異なるものになる (2)透視用BHフィルタ（軟X線除去フィルタ）が設定値とは異なるものになる (3)計算により表示される照射線量が実際に照射される線量より高い値で表示される（面積線量計をご使用の場 合は正しい照射線量の値が表示されます） このため、問題の発生防止の対策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
上記の不具合事象については、以下の理由により重篤な健康被害は発生いたしません。 (1)照射線量が設定値より増加する可能性がありますが、通常では使用しないような操作であり、問題が発生する ことはありません。 (2)照射線量が設定値より増加する可能性がありますが、表示される照射線量は実際の照射線量を正しく示して おり、この値にもとづいて線量管理することが可能です。 (3)計算により表示される照射線量の値は実際に照射される線量より高い値を表示しますが、線量は設定した通 りの線量が出ているため過剰な線量を与えることはありません。 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4年2月7日
効能・効果又は用途等
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。
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