参照元URL : https://www.mhlw.go.jp/haishin/u/l?p=t0uO00I2-95Ols0lY
照会先
医薬・生活衛生局監視指導・麻薬対策課
課長補佐:日田 充 (2763)
係長:伊藤 竜太 (2766)
(直通電話) 03 (3595) 2436
医薬・生活衛生局医薬安全対策課
室長:江野 英夫 (2755)
主査:岩瀬 怜 (2751)
(直通電話) 03 (3595) 2435
報道関係者 各位
医療機器自主回収のお知らせ(クラスⅠ)
(販売名:メドトロニック Adapta DR、メドトロニック Adapta VDD、メドトロニック Versa DR、メドトロニック Sensia DR)
本日、東京都より、平成31年1月18日付けで日本メドトロニック株式会社が自主回収に着手した医療機器について、別添のとおり、自主回収を行う製品及び製造番号が追加となった旨の情報提供がなされましたので、お知らせいたします。
また、追加で回収対象となった製品の製造番号も併せてお知らせいたします。
一般的名称:植込み型心臓ペースメーカ
販売名:(1)メドトロニック Adapta DR
(2)メドトロニック Adapta VDD
(3)メドトロニック Versa DR
(4)メドトロニック Sensia DR(※新規追加)
出荷数量:(1)1743個(※706個追加)
(2)133個(※42個追加)
(3)57個(※27個追加)
(4)3個(※新規追加)
出荷時期:平成29年7月28日~平成31年1月7日
(※)1月18日から変更となった製品、出荷数量
今回新たに回収対象となった製造番号:
(1)メドトロニック Adapta DR
NWB101745G,NWB102207G,NWB102209G,NWB102211G,NWB102213G,NWB102214G,
NWB102215G,NWB102219G,NWB102220G,NWB102227G,NWB102228G,NWB103311G,
NWB103313G,NWB103317G,NWB103319G,NWB103324G,NWB103328G,NWB103331G,
NWB103332G,NWB103334G,NWB103335G,NWB103337G,NWB103338G,NWB103342G,
NWB103345G,NWB103347G,NWB103366G,NWB103489G,NWB103494G,NWB103499G,
NWB103505G,NWB103506G,NWB103509G,NWB103510G,NWB103512G,NWB103513G,
NWB103514G,NWB103975G,NWB103978G,NWB103981G,NWB103983G,NWB103984G,
NWB103989G,NWB103990G,NWB103995G,NWB104245G,NWB104248G,NWB104249G,
NWB105671G,NWB105674G,NWB105679G,NWB105681G,NWB105682G,NWB105683G,
NWB105687G,NWB105689G,NWB105692G,NWB106105G,NWB106109G,NWB106115G,
NWB106116G,NWB106125G,NWB106588G,NWB106770G,NWB106807G,NWB106824G,
NWB107845G,NWB107851G,NWB107875G,NWB107877G,NWB107884G,NWB107885G,
NWB107917G,NWB107929G,NWB107940G,NWB107946G,NWB107950G,NWB107955G,
NWB107957G,NWB107961G,NWB107967G,NWB107970G,NWB107974G,NWB107979G,
NWB107983G,NWB107988G,NWB107992G,NWB108161G,NWB108169G,NWB108171G,
NWB108174G,NWB108178G,NWB109489G,NWB109584G,NWB109608G,NWB109626G,
NWB109628G,NWB109767G,NWB109809G,NWB110611G,NWB110613G,NWB110616G,
NWB110617G,NWB110619G,NWB110621G,NWB110633G,NWB110861G,NWB110862G,
NWB110863G,NWB110898G,NWB110941G,NWB110942G,NWB110943G,NWB110947G,
NWB110948G,NWB110950G,NWB110952G,NWB110953G,NWB112651G,NWB112655G,
NWB112656G,NWB112660G,NWB112662G,NWB112664G,NWB112669G,NWB113265G,
NWB113266G,NWB113313G,NWB113319G,NWB113342G,NWB113367G,NWB113484G,
NWB113494G,NWB113495G,NWB113496G,NWB113506G,NWB113508G,NWB113509G,
NWB113510G,NWB113511G,NWB113512G,NWB113517G,NWB113563G,NWB113564G,
NWB113567G,NWB113568G,NWB113569G,NWB113571G,NWB113572G,NWB113573G,
NWB113574G,NWB113575G,NWB113577G,NWB113578G,NWB113579G,NWB113580G,
NWB113581G,NWB113582G,NWB113583G,NWB113584G,NWB113586G,NWB113587G,
NWB113588G,NWB113589G,NWB113591G,NWB113819G,NWB113820G,NWB113821G,
NWB113822G,NWB113823G,NWB113824G,NWB113825G,NWB113826G,NWB113847G,
NWB113848G,NWB113849G,NWB113850G,NWB113851G,NWB113852G,NWB113853G,
NWB114041G,NWB114043G,NWB114044G,NWB114045G,NWB114047G,NWB114048G,
NWB114050G,NWB114051G,NWB114052G,NWB114054G,NWB114055G,NWB114057G,
NWB114058G,NWB114059G,NWB114062G,NWB114063G,NWB114064G,NWB114065G,
NWB114903G,NWB114993G,NWB115053G,NWB115054G,NWB115056G,NWB115057G,
NWB115058G,NWB115064G,NWB115065G,NWB115066G,NWB115067G,NWB115068G,
NWB115069G,NWB115070G,NWB115071G,NWB115072G,NWB115073G,NWB115074G,
NWB115075G,NWB115077G,NWB115080G,NWB115081G,NWB115083G,NWB115085G,
NWB115086G,NWB115087G,NWB115088G,NWB115089G,NWB970249S,NWB970250S,
NWB970252S,NWB970254S,NWD007203G,NWD007261G,NWD007263G,NWD007265G,
NWD007349G,NWD007350G,NWD007463G,NWD007465G,NWD007484G,NWD007488G,
NWD007619G,NWD007620G,NWD007635G,NWD007636G,NWD007703G,NWD007704G,
NWD007717G,NWD007750G,NWD007752G,NWD007824G,NWC703967S,NWC704050S,
NWC704069S,NWC704086S,NWC704089S,NWC704111S,NWC704113S,NWC704114S,
NWE044172G,NWE044175G,NWE044178G,NWE044179G,NWE044185G,NWE044186G,
NWE044210G,NWE044211G,NWE044213G,NWE044215G,NWE044218G,NWE044221G,
NWE044223G,NWE044226G,NWE044227G,NWE044229G,NWE044252G,NWE044255G,
NWE044265G,NWE044266G,NWE044269G,NWE044270G,NWE044273G,NWE044276G,
NWE045675G,NWE045676G,NWE045677G,NWE045678G,NWE045680G,NWE045681G,
NWE045683G,NWE045689G,NWE045690G,NWE045753G,NWE045754G,NWE045757G,
NWE045762G,NWE045764G,NWE045767G,NWE045769G,NWE045770G,NWE045775G,
NWE045777G,NWE045779G,NWE045780G,NWE045781G,NWE045782G,NWE045784G,
NWE045785G,NWE045787G,NWE045789G,NWE045791G,NWE045792G,NWE045793G,
NWE045797G,NWE045798G,NWE045812G,NWE045814G,NWE045816G,NWE045817G,
NWE045818G,NWE045819G,NWE045821G,NWE045823G,NWE045826G,NWE045827G,
NWE045831G,NWE045832G,NWE045836G,NWE045837G,NWE045842G,NWE045844G,
NWE045858G,NWE045859G,NWE045860G,NWE045861G,NWE045882G,NWE045883G,
NWE045884G,NWE045885G,NWE045886G,NWE045887G,NWE045888G,NWE045890G,
NWE045892G,NWE045896G,NWE045902G,NWE045905G,NWE045906G,NWE045908G,
NWE045909G,NWE045911G,NWE045912G,NWE045913G,NWE045914G,NWE045916G,
NWE045917G,NWE045918G,NWE045919G,NWE045921G,NWE045922G,NWE045923G,
NWE045924G,NWE045925G,NWE045926G,NWE050839G,NWE050846G,NWE050943G,
NWE050944G,NWE050945G,NWE051155G,NWE051156G,NWE051157G,NWE051158G,
NWE051159G,NWE051160G,NWE051161G,NWE051162G,NWE051163G,NWE051165G,
NWE051169G,NWE051170G,NWE051171G,NWE051172G,NWE051173G,NWE051174G,
NWE051340G,NWE051341G,NWE051342G,NWE051343G,NWE051344G,NWE051345G,
NWE051346G,NWE051347G,NWE051348G,NWE051349G,NWE051351G,NWE051352G,
NWE051354G,NWE051355G,NWE051358G,NWE051361G,NWE051363G,NWE051367G,
NWE052349G,NWE052350G,NWE052351G,NWE052352G,NWE052354G,NWE052355G,
NWE052356G,NWE052357G,NWE052358G,NWE052359G,NWE052376G,NWE052377G,
NWE052378G,NWE052379G,NWE052380G,NWE052694G,NWE052695G,NWE052696G,
NWE052917G,NWE052918G,NWE052919G,NWE052920G,NWE052922G,NWE052923G,
NWE052925G,NWE052926G,NWE052927G,NWE052938G,NWE052939G,NWE052940G,
NWE052941G,NWE052942G,NWE052943G,NWE052944G,NWE052945G,NWE052946G,
NWE052948G,NWE053016G,NWE053017G,NWE053018G,NWE053019G,NWE053020G,
NWE053021G,NWE053022G,NWE053023G,NWE053024G,NWE053025G,NWE053026G,
NWE053027G,NWE053028G,NWE053029G,NWE053030G,NWE053031G,NWE053032G,
NWE053033G,NWE053034G,NWE053035G,NWA015469G,NWA015474G,NWA015493G,
NWA015571G,NWA015591G,NWA015598G,NWA015602G,NWA015631G,NWA015642G,
NWA015657G,NWA015664G,NWA015667G,NWA015678G,NWA015684G,NWA015688G,
NWA015691G,NWA015697G,NWA015927G,NWA015930G,NWA015938G,NWA015939G,
NWA015942G,NWA015944G,NWA015949G,NWA015954G,NWA015958G,NWA016088G,
NWA016169G,NWA016174G,NWA016175G,NWA016178G,NWA016180G,NWA016186G,
NWA016188G,NWA016189G,NWA016193G,NWA016195G,NWA016210G,NWA016211G,
NWA016212G,NWA016214G,NWA016215G,NWA016218G,NWA016225G,NWA016227G,
NWA016245G,NWA016383G,NWA016391G,NWA016393G,NWA016395G,NWA016397G,
NWA016406G,NWA016409G,NWA016434G,NWA016449G,NWA016453G,NWA016455G,
NWA016462G,NWA016491G,NWA016496G,NWA016498G,NWA016499G,NWA016502G,
NWA016503G,NWA016504G,NWA016505G,NWA016512G,NWA016514G,NWA016519G,
NWA016520G,NWA016523G,NWA016526G,NWA016527G,NWA016528G,NWA016533G,
NWA016562G,NWA016564G,NWA016566G,NWA016569G,NWA016575G,NWA016578G,
NWA016598G,NWA016602G,NWA016613G,NWA016617G,NWA016624G,NWA016630G,
NWA016737G,NWA016738G,NWA016739G,NWA016741G,NWA016742G,NWA016744G,
NWA016748G,NWA016750G,NWA016751G,NWA016753G,NWA016756G,NWA016757G,
NWA016759G,NWA016760G,NWA016761G,NWA016762G,NWA016767G,NWA016775G,
NWA016777G,NWA016781G,NWA016783G,NWA016785G,NWA016787G,NWA016790G,
NWA016796G,NWA016797G,NWA016798G,NWA016805G,NWA016806G,NWA016808G,
NWA016809G,NWA016813G,NWA016822G,NWA016823G,NWA016824G,NWA016827G,
NWA016828G,NWA016829G,NWA016830G,NWA016831G,NWA016833G,NWA016837G,
NWA016839G,NWA016840G,NWA016841G,NWA016842G,NWA016858G,NWA016859G,
NWA016864G,NWA016865G,NWA016867G,NWA016869G,NWA016871G,NWA016872G,
NWA016875G,NWA016908G,NWA016913G,NWA016915G,NWA016917G,NWA016918G,
NWA016921G,NWA016924G,NWA016925G,NWA016928G,NWA016931G,NWA016932G,
NWA016935G,NWA016936G,NWA016937G,NWA016938G,NWA016939G,NWA016940G,
NWA016943G,NWA016944G,NWA016945G,NWA016946G,NWA016947G,NWA016953G,
NWA016954G,NWA016961G,NWA016962G,NWA016963G,NWA016965G,NWA016966G,
NWA016972G,NWA016973G,NWA016974G,NWA016975G,NWA016976G,NWA016977G,
NWA016980G,NWA016981G,NWA016982G,NWA016983G,NWA016984G,NWA016985G,
NWA016986G,NWA016987G,NWA016988G,NWA016990G,NWA016991G,NWA016992G,
NWA016994G,NWA017003G,NWA017004G,NWA017005G,NWA017009G,NWA017010G,
NWA017011G,NWA017012G,NWA017013G,NWA017014G,NWA017015G,NWA017016G,
NWA017017G,NWA017018G,NWA017019G,NWA017020G,NWA017021G,NWA017022G,
NWA017023G,NWA017024G,NWA017025G,NWA017026G,NWA017027G,NWA017028G,
NWA017030G,NWA017031G,NWA017032G,NWA017033G,NWA017034G,NWA017036G,
NWA017037G,NWA017038G,NWA017041G,NWA017042G,NWA017043G,NWA017044G,
NWA017045G,NWA017046G,NWA017047G,NWA017056G,NWA017057G,NWA017058G,
NWA017059G,NWA017060G,NWA017061G,NWA017063G,NWA017064G,NWA017065G,
NWA017069G,NWA017070G,NWA017073G,NWA017075G,NWA017077G,NWA017079G,
NWA017081G,NWA017083G,NWA017084G,NWA017085G
(2)メドトロニック Adapta VDD
NWG024816G,NWG025011G,NWG025017G,NWG025073G,NWG025076G,NWG025283G,
NWG025494G,NWG025666G,NWG025739G,NWG026155G,NWG026609G,NWG026774G,
NWG026775G,NWG026838G,NWG026840G,NWG026842G,NWG026845G,NWG026857G,
NWG027082G,NWG027084G,NWG028208G,NWG028209G,NWG028210G,NWG028427G,
NWG028428G,NWG028429G,NWG028432G,NWG028436G,NWG028437G,NWG028524G,
NWG028754G,NWG028755G,NWG028756G,NWG028757G,NWG028758G,NWG028759G,
NWG028760G,NWG028765G,NWG028766G,NWG028768G,NWG028769G,NWG028770G
(3)メドトロニック Versa DR
NWH015002G,NWH015030G,NWH015031G,NWH015035G,NWH015036G,NWH015037G,
NWH015039G,NWH015041G,NWH015043G,NWH015047G,NWH015067G,NWH015068G,
NWH015069G,NWH015070G,NWH015071G,NWH015084G,NWH015085G,NWH015162G,
NWH015163G,NWH015164G,NWH015165G,NWH015166G,NWH015168G,NWH015169G,
NWH015200G,NWH015201G,NWH015202G
(4)メドトロニック Sensia DR
NWL400331G,NWL416991G,NWL416996G