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令和 5年 3月15日作成 令和 5年 4月 4日訂正(*)
一般的名称及び販売名
一般的名称: 汎用超音波画像診断装置 販売名 : 汎用超音波画像診断装置 Vscan Air
対象ロット、数量及び出荷時期
製造番号 : VA002000602、VA002000603、VA002000604、VA002000605、VA002000607、VA002000608、VA002000609 VA002000610、VA002000612、VA002000613、VA002000614、VA002000615、VA002000617、VA002000618 VA002000621、VA002000622、VA002000623、VA002000624、VA002000625、VA002000627、VA002000628 VA002000629、VA002000630、VA002000631、VA002000632、VA002000633、VA002000634、VA002000635 VA002000637、VA002000639、VA002000640、VA002000641、VA002000643、VA002000644、VA002000647 VA002000649、VA002000650、VA002000651、VA002000652、VA002000653、VA002000655、VA002000656 VA002000657、VA002000658、VA002000659、VA002000660、VA002000662、VA002000663、VA002000665 VA002000666、VA002000668、VA002000669、VA002000670、VA002000671、VA002000673、VA002000675 VA002000676、VA002000677、VA002000678、VA002000679、VA002000680、VA002000681、VA002000682 VA002000684、VA002000685、VA002000688、VA002000689、VA002000690、VA002000691、VA002000692 VA002000694、VA002000695、VA002000696、VA002000697、VA002000698、VA002000699、VA002000700 VA002000701、VA002000702、VA002000703、VA002000704、VA002000705、VA002000706、VA002000707 VA002000708、VA002000709、VA002000711、VA002000712、VA002000713、VA002000714、VA002000715 VA002000716、VA002000717、VA002000718、VA002000719、VA002000720、VA002000721、VA002000722 VA002000723、VA002000724、VA002000725、VA002000726、VA002000727、VA002000728、VA002000729 VA002000730、VA002000731、VA002000732、VA002000734、VA002000736、VA002000737、VA002000738 VA002000739、VA002000741、VA002000742、VA002000743、VA002000744、VA002000745、VA002000746 VA002000747、VA002000748、VA002000749、VA002000750、VA002000751、VA002000752、VA002000754 VA002000755、VA002000756、VA002000757、VA002000758、VA002000759、VA002000760、VA002000761 VA002000762、VA002000763、VA002000764、VA002000765、VA002000766、VA002000767、VA002000768 VA002000769、VA002000770、VA002000771、VA002000773、VA002000774、VA002000775、VA002000776 VA002000777、VA002000779、VA002000780、VA002000781、VA002000782、VA002000783、VA002000784 VA002000785、VA002000787、VA002000788、VA002000789、VA002000790、VA002000793、VA002000794 VA002000796、VA002000797、VA002000798、VA002000799、VA002000800、VA002000802、VA002000803 VA002000804、VA002000806、VA002000807、VA002000808、VA002000809、VA002000810、VA002000811 VA002000812、VA002000813、VA002000815、VA002000816、VA002000817、VA002000819、VA002000820 VA002000821、VA002000822、VA002000823、VA002000824、VA002000825、VA002000827、VA002000828 VA002000829、VA002000832、VA002000833、VA002000834、VA002000835、VA002000836、VA002000838 VA002000839、VA002000840、VA002000841、VA002000842、VA002000843、VA002000844、VA002000845 VA002000846、VA002000847、VA002000848、VA002000849、VA002000850、VA002000851、VA002000852 VA002000853、VA002000854、VA002000855、VA002000856、VA002000858、VA002000859、VA002000860 VA002000861、VA002000863、VA002000864、VA002000865、VA002000866、VA002000867、VA002000868 VA002000870、VA002000871、VA002000872、VA002000873、VA002000874、VA002000875、VA002000876 VA002000877、VA002000878、VA002000880、VA002000881、VA002000882、VA002000883、VA002000884 VA002000885、VA002000887、VA002000888、VA002000889、VA002000891、VA002000892、VA002000893 VA002000894、VA002000895、VA002000896、VA002000897、VA002000898、VA002000899、VA002000900 VA002000901、VA002000902、VA002000903、VA002000904、VA002000905、VA002000906、VA002000907 VA002000908、VA002000909、VA002000910、VA002000911、VA002000912、VA002000914、VA002000915 VA002000916、VA002000917、VA002000918、VA002000919、VA002000920、VA002000921、VA002000922 VA002000923、VA002000924、VA002000925、VA002000926、VA002000927、VA002000928、VA002000929 VA002000930、VA002000931、VA002000932、VA002000933、VA002000934、VA002000935、VA002000937 VA002000938、VA002000939、VA002000940、VA002000941、VA002000942、VA002000943、VA002000944 VA002000945、VA002000946、VA002000947、VA002000948、VA002000949、VA002000950、VA002000951 VA002000952、VA002000953、VA002000954、VA002000955、VA002000956、VA002000957、VA002000958 VA002000959、VA002000960、VA002000961、VA002000962、VA002000963、VA002000964、VA002000965 VA002000966、VA002000967、VA002000968、VA002000969、VA002000970、VA002000971、VA002000972 VA002000973、VA002000974、VA002000975、VA002000976、VA002000977、VA002000978、VA002000979 VA002000980、VA002000982、VA002000983、VA002000984、VA002000985、VA002000986、VA002000987 VA002000988、VA002000989、VA002000990、VA002000991、VA002000992、VA002000993、VA002000994 VA002000995、VA002000997、VA002000998、VA002000999、VA002001000、VA002001001、VA002001002 VA002001003、VA002001004、VA002001005、VA002001006、VA002001007、VA002001008、VA002001009 VA002001010、VA002001011、VA002001012、VA002001013、VA002001014、VA002001015、VA002001016 VA002001017、VA002001018、VA002001019、VA002001020、VA002001021、VA002001022、VA002001023 VA002001024、VA002001025、VA002001026、VA002001027、VA002001028、VA002001029、VA002001030 VA002001031、VA002001032、VA002001033、VA002001034、VA002001035、VA002001036、VA002001038 VA002001039、VA002001040、VA002001041、VA002001042、VA002001043、VA002001044、VA002001045 VA002001046、VA002001047、VA002001048、VA002001049、VA002001050、VA002001051、VA002001053 VA002001054、VA002001055、VA002001056、VA002001057、VA002001058、VA002001059、VA002001060 VA002001061、VA002001062、VA002001063、VA002001064、VA002001065、VA002001066、VA002001067 VA002001068、VA002001069、VA002001070、VA002001071、VA002001072、VA002001073、VA002001074 VA002001075、VA002001076、VA002001077、VA002001078、VA002001079、VA002001080、VA002001081 VA002001082、VA002001083、VA002001084、VA002001085、VA002001086、VA002001087、VA002001088 VA002001089、VA002001090、VA002001091、VA002001092、VA002001093、VA002001094、VA002001095 VA002001096、VA002001098、VA002001099、VA002001100、VA002001101、VA002001102、VA002001103 VA002001104、VA002001105、VA002001106、VA002001107、VA002001108、VA002001109、VA002001110 VA002001111、VA002001112、VA002001113、VA002001114、VA002001115、VA002001117、VA002001118 VA002001119、VA002001120、VA002001121、VA002001122、VA002001123、VA002001124、VA002001125 VA002001126、VA002001127、VA002001128、VA002001129、VA002001130、VA002001132、VA002001134 VA002001135、VA002001136、VA002001137、VA002001138、VA002001139、VA002001140、VA002001141 VA002001142、VA002001143、VA002001144、VA002001145、VA002001147、VA002001148、VA002001149 VA002001150、VA002001151、VA002001152、VA002001153、VA002001154、VA002001155、VA002001156 VA002001157、VA002001158、VA002001159、VA002001160、VA002001161、VA002001162、VA002001163 VA002001164、VA002001165、VA002001166、VA002001167、VA002001168、VA002001169、VA002001170 VA002001171、VA002001172、VA002001173、VA002001174、VA002001175、VA002001176、VA002001177 VA002001178、VA002001179、VA002001180、VA002001181、VA002001182、VA002001183、VA002001184 VA002001185、VA002001186、VA002001187、VA002001188、VA002001189、VA002001190、VA002001191 VA002001192、VA002001193、VA002001194、VA002001195、VA002001197、VA002001198、VA002001199 VA002001200、VA002001201、VA002001202、VA002001203、VA002001204、VA002001205、VA002001206 VA002001207、VA002001210、VA002001211、VA002001212、VA002001213、VA002001215、VA002001216 VA002001217、VA002001218、VA002001219、VA002001221、VA002001222、VA002001223、VA002001224 VA002001225、VA002001226、VA002001227、VA002001228、VA002001229、VA002001230、VA002001231 VA002001232、VA002001233、VA002001235、VA002001236、VA002001237、VA002001238、VA002001239 VA002001240、VA002001241、VA002001242、VA002001243、VA002001244、VA002001247、VA002001248 VA002001249、VA002001250、VA002001251、VA002001252、VA002001253、VA002001254、VA002001256 VA002001257、VA002001258、VA002001259、VA002001260、VA002001261、VA002001262、VA002001263 VA002001264、VA002001265、VA002001266、VA002001267、VA002001268、VA002001269、VA002001270 VA002001271、VA002001272、VA002001273、VA002001274、VA002001275、VA002001276、VA002001277 VA002001278、VA002001279、VA002001280、VA002001282、VA002001283、VA002001285、VA002001286 VA002001287、VA002001288、VA002001289、VA002001292、VA002001294、VA002001295、VA002001296 VA002001297、VA002001299、VA002001300、VA002001301、VA002001302、VA002001303、VA002001305 VA002001306、VA002001307、VA002001308、VA002001309、VA002001310、VA002001311、VA002001312 VA002001313、VA002001314、VA002001315、VA002001316、VA002001317、VA002001318、VA002001319 VA002001320、VA002001321、VA002001322、VA002001323、VA002001325、VA002001326、VA002001327 VA002001328、VA002001329、VA002001330、VA002001331、VA002001332、VA002001333、VA002001338 VA002001339、VA002001341、VA002001343、VA002001344、VA002001345、VA002001346、VA002001347 VA002001348、VA002001350、VA002001351、VA002001352、VA002001353、VA002001354、VA002001355 VA002001356、VA002001357、VA002001358、VA002001359、VA002001360、VA002001361、VA002001362 VA002001363、VA002001364、VA002001365、VA002001366、VA002001367、VA002001369、VA002001370 VA002001371、VA002001372、VA002001373、VA002001374、VA002001375、VA002001376、VA002001377 VA002001380、VA002001381、VA002001382、VA002001383、VA002001384、VA002001385、VA002001386 VA002001387、VA002001388、VA002001389、VA002001390、VA002001391、VA002001392、VA002001393 VA002001394、VA002001395、VA002001396、VA002001398、VA002001399、VA002001400、VA002001401 VA002001402、VA002001403、VA002001404、VA002001405、VA002001406、VA002001407、VA002001408 VA002001409、VA002001410、VA002001411、VA002001412、VA002001413、VA002001414、VA002001415 VA002001416、VA002001417、VA002001418、VA002001419、VA002001420、VA002001421、VA002001422 VA002001423、VA002001424、VA002001425、VA002001426、VA002001427、VA002001428、VA002001429 VA002001430、VA002001431、VA002001432、VA002001433、VA002001435、VA002001436、VA002001437 VA002001438、VA002001439、VA002001440、VA002001441、VA002001442、VA002001443、VA002001444 VA002001445、VA002001446、VA002001447、VA002001448、VA002001449、VA002001450、VA002001451 VA002001452、VA002001453、VA002001454、VA002001455、VA002001456、VA002001457、VA002001458 VA002001459、VA002001460、VA002001461、VA002001462、VA002001463、VA002001464、VA002001465 VA002001466、VA002001467、VA002001468、VA002001469、VA002001470、VA002001471、VA002001472 VA002001473、VA002001474、VA002001476、VA002001477、VA002001478、VA002001479、VA002001480 VA002001481、VA002001482、VA002001483、VA002001484、VA002001485、VA002001486、VA002001487 VA002001488、VA002001489、VA002001490、VA002001491、VA002001492、VA002001493、VA002001494 VA002001495、VA002001496、VA002001497、VA002001498、VA002001499、VA002001500、VA002001501 VA002001502、VA002001503、VA002001504、VA002001505、VA002001506、VA002001507、VA002001508 VA002001509、VA002001510、VA002001511、VA002001512、VA002001513、VA002001514、VA002001516 VA002001517、VA002001518、VA002001519、VA002001520、VA002001521、VA002001522、VA002001523 VA002001524、VA002001525、VA002001526、VA002001527、VA002001529、VA002001530、VA002001531 VA002001532、VA002001533、VA002001534、VA002001535、VA002001536、VA002001537、VA002001538 VA002001539、VA002001540、VA002001541、VA002001542、VA002001543、VA002001544、VA002001545 VA002001546、VA002001547、VA002001548、VA002001549、VA002001550、VA002001551、VA002001552 VA002001553、VA002001554、VA002001555、VA002001556、VA002001557、VA002001558、VA002001559 VA002001560、VA002001561、VA002001563、VA002001564、VA002001565、VA002001566、VA002001567 VA002001568、VA002001569、VA002001570、VA002001571、VA002001572、VA002001573、VA002001574 VA002001575、VA002001576、VA002001577、VA002001578、VA002001579、VA002001580、VA002001581 VA002001582、VA002001583、VA002001584、VA002001585、VA002001586、VA002001587、VA002001588 VA002001589、VA002001590、VA002001591、VA002001592、VA002001593、VA002001594、VA002001595 VA002001596、VA002001597、VA002001598、VA002001599、VA002001600、VA002001601、VA002001602 VA002001603、VA002001604、VA002001605、VA002001606、VA002001607、VA002001608、VA002001609 VA002001610、VA002001611、VA002001612、VA002001613、VA002001614、VA002001615、VA002001616 VA002001617、VA002001618、VA002001619、VA002001620、VA002001621、VA002001622、VA002001623 VA002001624、VA002001625、VA002001626、VA002001627、VA002001628、VA002001629、VA002001630 VA002001631、VA002001632、VA002001633、VA002001634、VA002001635、VA002001636、VA002001637 VA002001638、VA002001639、VA002001640、VA002001641、VA002001642、VA002001643、VA002001644 VA002001645、VA002001646、VA002001647、VA002001648、VA002001649、VA002001650、VA002001651 VA002001652、VA002001653、VA002001654、VA002001655、VA002001656、VA002001657、VA002001658 VA002001659、VA002001660、VA002001661、VA002001662、VA002001663、VA002001664、VA002001665 VA002001666、VA002001667、VA002001668、VA002001669、VA002001670、VA002001671、VA002001672 VA002001673、VA002001674、VA002001675、VA002001676、VA002001677、VA002001678、VA002001679 VA002001680、VA002001681、VA002001683、VA002001684、VA002001685、VA002001686、VA002001687 VA002001688、VA002001689、VA002001690、VA002001691、VA002001692、VA002001693、VA002001694 VA002001695、VA002001697、VA002001698、VA002001700、VA002001701、VA002001702、VA002001703 VA002001704、VA002001705、VA002001706、VA002001707、VA002001708、VA002001710、VA002001711 VA002001712、VA002001713、VA002001714、VA002001715、VA002001716、VA002001717、VA002001718 VA002001719、VA002001720、VA002001721、VA002001722、VA002001723、VA002001724、VA002001725 VA002001726、VA002001727、VA002001728、VA002001729、VA002001730、VA002001731、VA002001732 VA002001733、VA002001734、VA002001735、VA002001736、VA002001737、VA002001738、VA002001739 VA002001740、VA002001741、VA002001742、VA002001743、VA002001744、VA002001745、VA002001746 VA002001747、VA002001748、VA002001749、VA002001750、VA002001751、VA002001752、VA002001753 VA002001754、VA002001755、VA002001756、VA002001757、VA002001758、VA002001759、VA002001760 VA002001761、VA002001762、VA002001763、VA002001764、VA002001765、VA002001766、VA002001767 VA002001768、VA002001769、VA002001771、VA002001772、VA002001773、VA002001774、VA002001775 VA002001776、VA002001777、VA002001778、VA002001779、VA002001780、VA002001781、VA002001782 VA002001783、VA002001784、VA002001785、VA002001786、VA002001787、VA002001788、VA002001789 VA002001790、VA002001791、VA002001792、VA002001794、VA002001795、VA002001796、VA002001797 VA002001798、VA002001799、VA002001800、VA002001801、VA002001802、VA002001803、VA002001804 VA002001805、VA002001806、VA002001807、VA002001808、VA002001809、VA002001810、VA002001811 VA002001812、VA002001813、VA002001815、VA002001816、VA002001817、VA002001818、VA002001819 VA002001820、VA002001821、VA002001822、VA002001823、VA002001824、VA002001826、VA002001827 VA002001828、VA002001829、VA002001830、VA002001831、VA002001833、VA002001834、VA002001835 VA002001836、VA002001837、VA002001838、VA002001840、VA002001841、VA002001842、VA002001843 VA002001844、VA002001846、VA002001847、VA002001848、VA002001849、VA002001850、VA002001851 VA002001852、VA002001854、VA002001856、VA002001857、VA002001858、VA002001859、VA002001860 VA002001861、VA002001862、VA002001863、VA002001867、VA002001868、VA002001869、VA002001870 VA002001871、VA002001872、VA002001873、VA002001874、VA002001875、VA002001876、VA002001877 VA002001878、VA002001879、VA002001880、VA002001881、VA002001882、VA002001883、VA002001884 VA002001885、VA002001886、VA002001887、VA002001888、VA002001889、VA002001890、VA002001891 VA002001892、VA002001893、VA002001894、VA002001895、VA002001896、VA002001897、VA002001900 VA002001902、VA002001903、VA002001904、VA002001906、VA002001907、VA002001908、VA002001909 VA002001910、VA002001911、VA002001914、VA002001917、VA002001918、VA002001919、VA002001920 VA002001921、VA002001922、VA002001923、VA002001924、VA002001925、VA002001926、VA002001927 VA002001928、VA002001929、VA002001930、VA002001931、VA002001932、VA002001933、VA002001935 VA002001936、VA002001938、VA002001939、VA002001940、VA002001941、VA002001942、VA002001943 VA002001944、VA002001945、VA002001946、VA002001947、VA002001948、VA002001949、VA002001950 VA002001951、VA002001952、VA002001953、VA002001954、VA002001955、VA002001956、VA002001957 VA002001958、VA002001959、VA002001961、VA002001962、VA002001963、VA002001964、VA002001965 VA002001966、VA002001967、VA002001968、VA002001969、VA002001970、VA002001971、VA002001972 VA002001973、VA002001974、VA002001975、VA002001976、VA002001977、VA002001978、VA002001979 VA002001980、VA002001981、VA002001982、VA002001983、VA002001984、VA002001985、VA002001986 VA002001987、VA002001988、VA002001989、VA002001990、VA002001991、VA002001993、VA002001994 VA002001995、VA002001996、VA002001997、VA002001998、VA002001999、VA002002000、VA002002001 VA002002002、VA002002003、VA002002004、VA002002005、VA002002006、VA002002007、VA002002008 VA002002009、VA002002010、VA002002011、VA002002012、VA002002013、VA002002014、VA002002015 VA002002016、VA002002017、VA002002018、VA002002019、VA002002020、VA002002021、VA002002022 VA002002023、VA002002024、VA002002025、VA002002026、VA002002027、VA002002028、VA002002029 VA002002030、VA002002031、VA002002032、VA002002033、VA002002034、VA002002035、VA002002036 VA002002037、VA002002038、VA002002039、VA002002040、VA002002041、VA002002042、VA002002043 VA002002044、VA002002046、VA002002047、VA002002048、VA002002049、VA002002050、VA002002051 VA002002052、VA002002053、VA002002054、VA002002055、VA002002056、VA002002058、VA002002059 VA002002060、VA002002061、VA002002062、VA002002064、VA002002065、VA002002066、VA002002067 VA002002068、VA002002069、VA002002070、VA002002071、VA002002072、VA002002073、VA002002074 VA002002075、VA002002076、VA002002077、VA002002078、VA002002080、VA002002081、VA002002082 VA002002083、VA002002084、VA002002085、VA002002086、VA002002087、VA002002088、VA002002089 VA002002090、VA002002091、VA002002092、VA002002093、VA002002094、VA002002095、VA002002096 VA002002097、VA002002098、VA002002099、VA002002100、VA002002101、VA002002102、VA002002103 VA002002104、VA002002105、VA002002106、VA002002107、VA002002108、VA002002110、VA002002111 VA002002112、VA002002113、VA002002114、VA002002115、VA002002116、VA002002117、VA002002118 VA002002119、VA002002120、VA002002121、VA002002122、VA002002123、VA002002124、VA002002125 VA002002126、VA002002127、VA002002128、VA002002129、VA002002130、VA002002131、VA002002132 VA002002133、VA002002134、VA002002135、VA002002136、VA002002137、VA002002138、VA002002139 VA002002140、VA002002141、VA002002142、VA002002143、VA002002144、VA002002145、VA002002146 VA002002147、VA002002148、VA002002149、VA002002150、VA002002151、VA002002152、VA002002153 VA002002154、VA002002155、VA002002156、VA002002157、VA002002158、VA002002159、VA002002160 VA002002161、VA002002162、VA002002163、VA002002164、VA002002166、VA002002167、VA002002168 VA002002169、VA002002170、VA002002172、VA002002173、VA002002174、VA002002175、VA002002176 VA002002177、VA002002178、VA002002179、VA002002180、VA002002181、VA002002182、VA002002183 VA002002184、VA002002185、VA002002186、VA002002188、VA002002189、VA002002190、VA002002191 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VA002002355、VA002002357、VA002002359、VA002002360、VA002002361、VA002002362、VA002002363 VA002002364、VA002002365、VA002002366、VA002002367、VA002002368、VA002002369、VA002002370 VA002002371、VA002002372、VA002002373、VA002002374、VA002002375、VA002002376、VA002002377 VA002002378、VA002002379、VA002002380、VA002002381、VA002002382、VA002002383、VA002002384 VA002002385、VA002002386、VA002002387、VA002002388、VA002002389、VA002002390、VA002002391 VA002002392、VA002002393、VA002002394、VA002002395、VA002002396、VA002002397、VA002002398 VA002002399、VA002002400、VA002002401、VA002002402、VA002002403、VA002002405、VA002002406 VA002002407、VA002002408、VA002002409、VA002002410、VA002002411、VA002002412、VA002002413 VA002002414、VA002002415、VA002002416、VA002002417、VA002002418、VA002002419、VA002002420 VA002002421、VA002002422、VA002002423、VA002002424、VA002002425、VA002002426、VA002002427 VA002002428、VA002002429、VA002002430、VA002002431、VA002002432、VA002002433、VA002002434 VA002002435、VA002002436、VA002002437、VA002002438、VA002002439、VA002002440、VA002002441 VA002002442、VA002002443、VA002002444、VA002002445、VA002002446、VA002002447、VA002002448 VA002002449、VA002002450、VA002002451、VA002002452、VA002002453、VA002002454、VA002002455 VA002002456、VA002002457、VA002002458、VA002002459、VA002002460、VA002002461、VA002002462 VA002002463、VA002002464、VA002002465、VA002002466、VA002002467、VA002002468、VA002002469 VA002002470、VA002002471、VA002002472、VA002002473、VA002002474、VA002002475、VA002002476 VA002002477、VA002002478、VA002002479、VA002002480、VA002002481、VA002002482、VA002002483 VA002002484、VA002002486、VA002002487、VA002002488、VA002002489、VA002002490、VA002002491 VA002002492、VA002002493、VA002002494、VA002002495、VA002002496、VA002002497、VA002002498 VA002002499、VA002002500、VA002002501、VA002002502、VA002002503、VA002002504、VA002002505 VA002002506、VA002002507、VA002002508、VA002002509、VA002002510、VA002002511、VA002002512 VA002002513、VA002002514、VA002002515、VA002002516、VA002002517、VA002002518、VA002002519 VA002002520、VA002002521、VA002002522、VA002002523、VA002002524、VA002002525、VA002002526 VA002002527、VA002002528、VA002002529、VA002002530、VA002002531、VA002002532、VA002002533 VA002002534、VA002002535、VA002002536、VA002002537、VA002002538、VA002002539、VA002002540 VA002002541、VA002002542、VA002002543、VA002002545、VA002002546、VA002002547、VA002002548 VA002002549、VA002002550、VA002002551、VA002002552、VA002002553、VA002002554、VA002002555 VA002002556、VA002002557、VA002002558、VA002002559、VA002002560、VA002002561、VA002002562 VA002002563、VA002002564、VA002002565、VA002002566、VA002002567、VA002002568、VA002002569 VA002002570、VA002002571、VA002002572、VA002002573、VA002002574、VA002002575、VA002002576 VA002002577、VA002002578、VA002002579、VA002002581、VA002002582、VA002002583、VA002002584 VA002002586、VA002002587、VA002002588、VA002002589、VA002002590、VA002002591、VA002002592 VA002002593、VA002002594、VA002002595、VA002002596、VA002002597、VA002002598、VA002002599 VA002002600、VA002002601、VA002002602、VA002002603、VA002002604、VA002002605、VA002002606 VA002002607、VA002002608、VA002002609、VA002002610、VA002002611、VA002002612、VA002002613 VA002002614、VA002002615、VA002002616、VA002002617、VA002002618、VA002002619、VA002002620 VA002002621、VA002002622、VA002002623、VA002002624、VA002002625、VA002002626、VA002002627 VA002002628、VA002002629、VA002002630、VA002002631、VA002002632、VA002002633、VA002002634 VA002002635、VA002002636、VA002002637、VA002002638、VA002002639、VA002002640、VA002002641 VA002002642、VA002002643、VA002002644、VA002002645、VA002002646、VA002002647、VA002002648 VA002002649、VA002002650、VA002002651、VA002002652、VA002002653、VA002002654、VA002002655 VA002002656、VA002002657、VA002002658、VA002002659、VA002002660、VA002002661、VA002002662 VA002002663、VA002002664、VA002002665、VA002002666、VA002002667、VA002002669、VA002002670 VA002002671、VA002002672、VA002002673、VA002002674、VA002002676、VA002002677、VA002002678 VA002002679、VA002002680、VA002002681、VA002002682、VA002002683、VA002002684、VA002002685 VA002002686、VA002002687、VA002002688、VA002002689、VA002002690、VA002002691、VA002002692 VA002002693、VA002002694、VA002002695、VA002002696、VA002002697、VA002002698、VA002002699 VA002002700、VA002002701、VA002002702、VA002002703、VA002002704、VA002002705、VA002002706 VA002002707、VA002002708、VA002002709、VA002002710、VA002002712、VA002002713、VA002002714 VA002002715、VA002002716、VA002002717、VA002002718、VA002002719、VA002002720、VA002002721 VA002002722、VA002002723、VA002002724、VA002002725、VA002002726、VA002002727、VA002002728 VA002002729、VA002002730、VA002002731、VA002002732、VA002002733、VA002002734、VA002002735 VA002002736、VA002002737、VA002002738、VA002002739、VA002002741、VA002002742、VA002002743 VA002002744、VA002002745、VA002002746、VA002002747、VA002002748、VA002002749、VA002002750 VA002002751、VA002002752、VA002002753、VA002002754、VA002002755、VA002002756、VA002002757 VA002002758、VA002002759、VA002002760、VA002002761、VA002002762、VA002002763、VA002002764 VA002002765、VA002002766、VA002002767、VA002002768、VA002002769、VA002002770、VA002002771 VA002002772、VA002002773、VA002002774、VA002002775、VA002002776、VA002002777、VA002002778 VA002002779、VA002002780、VA002002781、VA002002782、VA002002783、VA002002784、VA002002785 VA002002786、VA002002787、VA002002788、VA002002789、VA002002790、VA002002791、VA002002792 VA002002793、VA002002794、VA002002795、VA002002796、VA002002797、VA002002798、VA002002799 VA002002800、VA002002801、VA002002802、VA002002803、VA002002804、VA002002805、VA002002806 VA002002807、VA002002808、VA002002809、VA002002810、VA002002811、VA002002812、VA002002813 VA002002814、VA002002815、VA002002816、VA002002817、VA002002818、VA002002819、VA002002820 VA002002821、VA002002822、VA002002823、VA002002824、VA002002825、VA002002826、VA002002827 VA002002828、VA002002829、VA002002830、VA002002831、VA002002832、VA002002833、VA002002834 VA002002835、VA002002836、VA002002837、VA002002838、VA002002839、VA002002842、VA002002843 VA002002844、VA002002845、VA002002846、VA002002847、VA002002848、VA002002849、VA002002850 VA002002851、VA002002852、VA002002853、VA002002854、VA002002855、VA002002856、VA002002857 VA002002858、VA002002859、VA002002860、VA002002861、VA002002862、VA002002863、VA002002864 VA002002865、VA002002866、VA002002867、VA002002868、VA002002869、VA002002870、VA002002871 VA002002872、VA002002873、VA002002874、VA002002875、VA002002876、VA002002877、VA002002878 VA002002879、VA002002880、VA002002881、VA002002882、VA002002883、VA002002884、VA002002885 VA002002886、VA002002887、VA002002888、VA002002889、VA002002890、VA002002891、VA002002892 VA002002893、VA002002894、VA002002895、VA002002896、VA002002897、VA002002898、VA002002899 VA002002900、VA002002901、VA002002902、VA002002903、VA002002904、VA002002905、VA002002906 VA002002907、VA002002908、VA002002909、VA002002910、VA002002911、VA002002912、VA002002913 VA002002914、VA002002915、VA002002916、VA002002917、VA002002918、VA002002919、VA002002920 VA002002921、VA002002922、VA002002923、VA002002924、VA002002925、VA002002926、VA002002927 VA002002928、VA002002929、VA002002930、VA002002931、VA002002932、VA002002933、VA002002934 VA002002935、VA002002936、VA002002937、VA002002938、VA002002940、VA002002941、VA002002942 VA002002943、VA002002945、VA002002946、VA002002947、VA002002950、VA002002951、VA002002952 VA002002954、VA002002956、VA002002958、VA002002959、VA002002961、VA002002963、VA002002967 VA002002968、VA002002969、VA002002970、VA002002972、VA002002973、VA002002975、VA002002977 VA002002978、VA002002979、VA002002980、VA002002983、VA002002984、VA002002985、VA002002987 VA002002988、VA002002989、VA002002991、VA002002993、VA002002994、VA002002995、VA002002996 VA002002998、VA002002999、VA002003001、VA002003003、VA002003004、VA002003006、VA002003007 VA002003008、VA002003009、VA002003010、VA002003011、VA002003012、VA002003014、VA002003015 VA002003017、VA002003018、VA002003019、VA002003020、VA002003021、VA002003022、VA002003024 VA002003025、VA002003026、VA002003027、VA002003028、VA002003029、VA002003030、VA002003031 VA002003032、VA002003033、VA002003034、VA002003035、VA002003036、VA002003037、VA002003038 VA002003039、VA002003040、VA002003042、VA002003043、VA002003044、VA002003047、VA002003048 VA002003049、VA002003050、VA002003051、VA002003052、VA002003053、VA002003054、VA002003055 VA002003056、VA002003057、VA002003058、VA002003059、VA002003060、VA002003061、VA002003063 VA002003065、VA002003066、VA002003067、VA002003068、VA002003070、VA002003071、VA002003072 VA002003073、VA002003074、VA002003075、VA002003076、VA002003078、VA002003081、VA002003082 VA002003083、VA002003084、VA002003087、VA002003090、VA002003091、VA002003092、VA002003093 VA002003094、VA002003095、VA002003097、VA002003098、VA002003099、VA002003100、VA002003102 VA002003103、VA002003104、VA002003106、VA002003107、VA002003108、VA002003109、VA002003110 VA002003112、VA002003114、VA002003117、VA002003118、VA002003119、VA002003121、VA002003123 VA002003124、VA002003125、VA002003126、VA002003129 数量 : 2328台 出荷時期 : 令和3年6月〜令和5年3月(*)
製造販売業者等名称
製造販売業者の名称 : GEヘルスケア・ジャパン株式会社 製造販売業者の所在地: 東京都日野市旭が丘4‐7‐127 許可の種類 : 第一種医療機器製造販売業 許可番号 : 13B1X00150 輸入先製造業者 : GE Vingmed Ultrasound AS(ノルウェー王国)
改修理由
製造元からの連絡により、製造元での社内検証中に、IEC 60601-2-37の静止空中試験で表面温度が50℃を超えな いという要求事項に適合せず、実際には2.1℃上回っていることが確認されました。このため、製造元の情報を 基に、お客様に情報提供を行うことで注意喚起を実施し、問題を修正したソフトウェアに変更する改修作業を実 施します。
危惧される具体的な健康被害
当該装置には、過熱のリスクを最小限に抑えるための自動フリーズモードがあるため、今回の問題が製品の動作 および性能に影響を及ぼすことはありません。そのため、製品の品質・有効性・安全性に問題はなく、健康被害 が発生することはないと考えます。なお、これまでに本事象による健康被害の発生は報告されておりません。
改修開始年月日
令和5年3月15日
効能・効果又は用途等
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装置です。
その他
納入いたしました医療機関は弊社が把握しておりますので、連絡の上、回収を実施します。
担当者及び連絡先
担当者 : 薬事・安全管理本部/品質保証統括部 對木 章太郎/杉浦 正規 連絡先 : GEヘルスケア・ジャパン株式会社 東京都日野市旭が丘4‐7‐127 電話番号: 080-4080-0860/080-3090-8178 FAX番号 : 042-585-5911