平成24年 9月 3日作成

一般的名称： 循環器用超音波画像診断装置
販売名　　： (1)ボルケーノs5 イメージング　システム
　　　　 　　(2)s5r イメージング　システム
　　　　　　 (3)s5i イメージング　システム
　　　　　　 (4)s5ix イメージング　システム

(1) ボルケーノs5 イメージング　システム
数量：358台
出荷時期:2006年8月23日〜2012年8月31日
シリアル：
05128,05129,05142,05146,05148,05152,05158,05161,05162,05171,05176,05179,
05183,05184,05188,05189,05191,05192,05193,05201,05203,05204,05241,05251,
05252,05255,05258,05278,05281,05283,05284,05285,05288,05296,05300,05301,
05323,05324,05353,05358,05376,05415,05417,05434,05442,05448,05513,05514,
05515,05545,05546,05547,05552,05558,05574,05575,05577,05578,05580,05582,
05610,05615,05652,05743,05765
05207050001,05207051001,05207052001,05207053001,05207055001,05207056001,
05207057001,05207058001,05207059001,05207060001,05207061001,05207062001,
05207063001,05207064001,05207065001,05207066001,05207067001,05207068001,
05207069001,05207071001,05207072001,05207073001,05207074001,05207075001,
05207076001,05207077001,05207078001,05207079001,05207080001,05207081001,
05207082001,05207083001,05207084001,05207085001,05207086001,05207088001,
05207090001,05207091001,05207092001,05207093001,05207094001,05207096001,
05207097001,05207098001,05207100001,05207101001,05207107001,05207109001,
05207110001,05207111001,05207112001,05207113001,05207114001,05207115001,
05207116001,05207117001,05207118001,05208376001,05208388001,05208392001,
05208394001,05208395001,05208396001,05208400001,05208430001,05208511001,
05208512001,05208513001,05208514001,05208515001,05208516001,05208517001,
05208518001,05208519001,05208520001,05208521001,05208524001,05208525001,
05208526001,05208528001,05208529001,05208530001,05208532001,05208533001,
05208534001,05208536001,05208541001,05208549001,05208552001,05208555001,
05208560001,05208562001,05208564001,05208566001,05208567001,05208572001,
05208573001,05208574001,05208586001,05208587001,05208590001,05208592001,
05208594001,05208595001,05208596001,05208597001,05208598001,05208602001,
05208603001,05208604001,05208614001,05208619001,05208630001,05208631001,
05208632001,05208653001,05208660001,05208661001,05208716001,05208733001,
05208744001,05208753001,05208755001,05208756001,05208757001,05208758001,
05209016001,05209023001,05209024001,05209028001,05209035001,05209037001,
05209038001,05209039001,05209040001,05209044001,05209045001,05209046001,
05209048001,05209049001,05209051001,05209053001,05209056001,05209057001,
05209058001,05209059001,05209060001,05209061001,05209062001,05209063001,
05209064001,05209065001,05209066001,05209067001,05209069001,05209070001,
05209071001,05209072001,05209073001,05209154001,05209156001,05209159001,
05209162001,05209163001,05209164001,05209165001,05209173001,05209181001,
05209193001,
102050001001,102050002001,102050003001,102050004001,102050005001,102050006001,
102050007001,102050008001,102050009001,102050010001,102050011001,102050012001,
102050013001,102050014001,102050015001,102050016001,102050017001,102050018001,
102050019001,102050020001,102050021001,102050022001,102050023001,102050024001,
102050025001,102050026001,102050027001,102050028001,102050029001,102050034001,
102050035001,102050036001,102050037001,102050038001,102050039001,102050041001,
102050042001,102050043001,102050044001,102050045001,102050046001,102050047001,
102050048001,102050049001,102050050001,102050051001,102050053001,102050054001,
102050055001,102050056001,102050057001,102050058001,102050059001,102050060001,
102050061001,102050062001,102050063001,102050064001,102050065001,102050066001,
102050067001,102050068001,102050069001,102050070001,102050072001,102050073001,
102050075001,102050076001,102050077001,102050078001,102050082001,102050084001,
102050085001,102050086001,102050087001,102050088001,102050089001,102050090001,
102050091001,102050092001,102050093001,102050094001,102050095001,102050096001,
102050097001,102050098001,102050099001,102050100001,102050101001,102050102001,
102050103001,102050104001,102050105001,102050106001,102050109001,102050110001,
102050111001,102050112001,102050113001,102050114001,102050115001,102050116001,
102050117001,102050118001,102050119001,102050120001,102050121001,102050122001,
102050123001,102050124001,102050125001,102050126001,102050127001,102050128001,
102050130001,102050131001,102050132001,102050134001,102050135001,102050136001,
102050137001,102050138001,102050139001,102050140001

(2) s5r イメージング　システム
数量：316台
出荷時期:2008年6月25日〜2012年8月31日
シリアル：
05206020001,05206083001,05206143001,05206144001,05206146001,05206147001,
05206156001,05206172001,05206174001,05206175001,05206178001,05206179001,
05206180001,05206181001,05206189001,05206236001,05206245001,05206246001,
05206249001,05206271001,05206272001,05206275001,05206278001,05206281001,
05206284001,05206287001,05206289001,05206292001,05206293001,05206295001,
05206297001,05206298001,05206299001,05206301001,05206302001,05206304001,
05206307001,05206312001,05206314001,05206323001,05206325001,05206339001,
05206345001,05206347001,05206351001,05206356001,05206358001,05206361001,
05206366001,05206368001,05206375001,05206376001,05206378001,05206384001,
05206385001,05206389001,05206390001,05206395001,05206399001,05206400001,
05206403001,05206405001,05206416001,05206418001,05206419001,05206429001,
05206431001,05206432001,05206433001,05206443001,05206444001,05206447001,
05206451001,05206457001,05206459001,05206463001,05206470001,05206474001,
05206477001,05206480001,05206481001,05206482001,05206483001,05206484001,
05206485001,05206486001,05206488001,05206492001,05206493001,05206494001,
05206499001,05206501001,05206502001,05206509001,05206517001,05206518001,
05206541001,05206543001,05206545001,05206546001,05206550001,05206552001,
05206553001,05206554001,05206559001,05206570001,05206572001,05206573001,
05206589001,05206590001,05206596001,05206597001,05206599001,05206602001,
05206603001,05206606001,05206607001,05206611001,05206614001,05206615001,
05206619001,05206626001,05206634001,05206637001,05206666001,05206667001,
05206673001,05206674001,05206675001,05206678001,05206680001,05206682001,
05206683001,05206686001,05206688001,05206700001,05206708001,05206717001,
05206745001,05206763001,05206773001,05206774001,05206777001,05206779001,
05206780001,05206781001,05206785001,05206786001,05206788001,05206793001,
05206797001,05206802001,05206804001,05206807001,05206808001,05206809001,
05206829001,05206832001,05206837001,05206841001,05206853001,05206859001,
05206862001,05206864001,05206866001,05206869001,05206870001,05206874001,
05206909001,05206910001,05206914001,05206916001,05206920001,05206921001,
05206923001,05206924001,05206926001,05206927001,05206928001,05206929001,
05206930001,05206931001,05206932001,05206933001,05206934001,05206936001,
05206937001,05206941001,05206942001,05206945001,05206946001,05206947001,
05206952001,05206958001,05206959001,05206961001,05206963001,05206965001,
05206966001,05206967001,05206968001,05206970001,05206971001,05206972001,
05206973001,05206974001,05206976001,05206977001,05206990001,05206996001,
05206998001,05207500001,05208012001,05208166001,05208169001,05208170001,
05208177001,05208193001,05208195001,05208201001,05208231001,05208236001,
05208314001,05208318001,05208324001,05208330001,05208360001,05208362001,
05208372001,05208373001,05208374001,05208375001,05208382001,05208383001,
05208384001,05303000001,05303001001,05303003001,05303004001,05303005001,
05303007001,05303008001,05303009001,05303011001,05303012001,05303013001,
05303014001,05303015001,05303017001,05303019001,05303021001,05303022001,
05303024001,05303027001,05303029001,05303031001,05303033001,05303035001,
05303036001,05303038001,05303039001,05303040001,05303041001,05303042001,
05303043001,05303044001,05303049001,05303050001,05303051001,05303052001,
05303054001,05303058001,05303059001,05303063001,05303064001,05303067001,
05303068001,05303069001,05303071001,05303073001,05303076001,05303077001,
05303078001,05303079001,05303080001,05303081001,05303084001,05303086001,
05303089001,05303090001,05303091001,05303092001,05303093001,05303094001,
05303096001,05303097001,05303099001,05303101001,05303106001,05303107001,
05303108001,05303109001,05303112001,05303113001,05303114001,05303116001,
05303117001,05303118001,05303119001,05303120001,05303123001,05303124001,
05303125001,05303128001,05303130001,05303132001

(3) s5i イメージング　システム
数量：59台
出荷時期:2008年5月29日〜2012年8月31日
シリアル：
06802089001,06802091001,06802092001,06802093001,06802094001,06802110001,
06802112001,06802114001,06802118001,06802119001,06802121001,06802247001,
06802250001,06802266001,06802267001,06802290001,06802477001,06802504001,
06802514001,06802521001,06802556001,06802580001,06802581001,06802582001,
06802593001,06802594001,06802606001,06802607001,06802623001,06802652001,
06802666001,06802671001,06802684001,06802695001,06802697001,06802699001,
06802900001,06802953001,06802957001,06802958001,06802972001,06802973001,
06802975001,06802984001,06802986001,06802989001,06802990001,06802991001,
06802993001,06802996001,06803023001,06803024001,06803025001,06803027001,
06803032001,06803034001,06803037001,06803038001,06803040001

(4) s5ix イメージング　システム
数量：77台
出荷時期:2010年9月24日〜2012年8月31日
シリアル：
06803102001,06803103001,06803107001,06803108001,06803109001,06803110001,
06803111001,06803112001,06803113001,06803114001,06803115001,06803116001,
06803117001,06803118001,06803119001,06803120001,06803121001,06803124001,
06803131001,06803132001,06803133001,06803134001,06803135001,06803136001,
06803137001,06803138001,06803139001,06803140001,06803141001,06803142001,
06803144001,06803145001,06803146001,06803177001,06803178001,06803179001,
06803180001,06803192001,06803194001,06803195001,06803199001,
102320001001,102320002001,102320003001,102320004001,102320005001,102320006001,
102320007001,102320008001,102320010001,102320011001,102320012001,102320014001,
102320015001,102320016001,102320017001,102320018001,102320019001,102320020001,
102320021001,102320022001,102320023001,102320024001,102320025001,102320027001,
102320028001,102320029001,102320030001,102320031001,102320032001,102320033001,
102320034001,102320101001,102320102001,102320103001,102320104001,102320105001

製造販売業者の名称　　： ボルケーノ・ジャパン株式会社
製造販売業者の所在地　： 東京都港区浜松町一丁目３０番５号　浜松町スクエア
許可の種類　　　　： 第一種医療機器製造販売業
許可番号　　　　　： 13B1X90005
輸入先製造業者　　：Volcano Corporation (アメリカ)

表示された画像が通常より小さく見える、および、画面が急に白くなった、との報告が合計2件医療施設より
あったため海外の製造元で原因を調査したところ、極めてまれにある特定の条件が重なった場合には画像表示
エラーが発生することが判明したためソフトウェアを対策品と入れ替える改修を実施することとしました。

本事象が発生した場合、画像の表示目盛が設定した値から初期設定に戻ってしまう、もしくは画面の輝度が著し
く上がるので医療従事者が容易に気付きます。
本システムは血管内部の状態を画像として提供し、血管造影による診断を補助する目的で使用します。本システ
ムが単独で使用されることはありませんので、本事象の発生が直接患者健康被害を誘発することは無いと考えら
れます。
万一本事象の発生に医療従事者が気付かなかった場合でも、その後の措置はX線透視下で確認しながら的確に行
われるため、重篤な健康被害の発生は無いと考えられます。
なお、これまでに本事象による患者健康被害の報告は受けていません。

平成24年9月3日

超音波を用いて体内の形状、性状又は動態を可視化し、画像情報を診断のために提供する。

担当者　： 品質保証部　下形拓史
連絡先　： ボルケーノ・ジャパン株式会社
　　　　 　東京都港区浜松町一丁目３０番５号　浜松町スクエア
電話番号： 03-6430-9407
FAX番号 ： 03-6430-9418