Device Recall GE Healthcare MUSE Cardiology Information Systems

  • Modèle / numéro de série
    Serial Numbers: SBP08365245GA, SBP08365257GA, SBP08124375GA, SBP07041811GA, SBP08164446GA, SBP08104129GA, SBP08104136GA, SBP08164458GA, SBP08385418GA, SBP07282702GA, SBP08124399GA, SBP07373018GA, SBP08194531GA, SBP08335087GA, SBP08335073GA, SBP07011728GA, SBP08164445GA, SBP07021744GA, SBP08365297GA, SBP05480036GA, SBP08335083GA, SBP08365284GA, SBP08365278GA, SBP08365282GA, SBP07423241GA, SBP08174469GA, SBP08194513GA, SBP08144422GA, SBP07463469GA, SBP07423262GA, SBP08365246GA, SBP06160272GA, SBP07463493GA, SBP07232542GA, SBP07182278GA, SBP07212445GA, SBP08124336GA, SBP08164453GA, SBP08144435GA, SBP08335106GA, SBP06300799GA, SBP08063821GA, SBP08023779GA, SBP08194514GA, SBP08335034GA, SBP07282642GA, SBP08294905GA, SBP08365260GA, SBP08114216GA, SBP07021746GA, SBP07232570GA, SBP08335088GA, SBP07081983GA, SBP08294892GA, SBP08104175GA, SBP08375355GA, SBP08184482GA, SBP08194534GA, SBP08244758GA, SBP08335108GA, SBP08114264GA, SBP08093988GA, SBP08335092GA, SBP07192318GA, SBP08375335GA, SBP07282681GA, SBP08335022GA, SBP08124374GA, SBP08104156GA, SBP07453378GA, SBP08194517GA, SBP08104154GA, SBP08204580GA, SBP08124395GA, SBP07282685GA, SBP08023778GA, SBP08335105GA, SBP08294899GA, SBP08355141GA, SBP07021745GA, SBP07082001GA, SBP08365244GA, SBP08365281GA, SBP08194523GA, SBP08224698GA, SBP08335090GA, SBP08355175GA, SBP08204613GA, SBP06330859GA, SBP08365270GA, SBP08053807GA, SBP08124365GA, SBP08365286GA, SBP08375351GA, SBP06441264GA, SBP08335107GA, SBP07061929GA, SBP08214644GA, SBP08114259GA, SBP08355167GA, SBP08194509GA, SBP08214646GA, SBP08124353GA, SBP07513715GA, SBP07021767GA, SBP08124385GA, SBP06330842GA, SBP08194506GA, SBP07252604GA, SBP07142196GA, SBP07312784GA, SBP08124383GA, SBP08385400GA, SBP08244734GA, SBP06451324GA, SBP08214658GA, SBP08335086GA, SBP08284827GA, SBP08124403GA, SBP06391110GA, SBP07182284GA, SBP08224699GA, SBP08244733GA, SBP08365202GA, SBP08124337GA, SBP08104105GA, SBP08104181GA, SBP07373052GA, SBP08184489GA, SBP08104149GA, SBP07503683GA, SBP08335109GA, SBP08335074GA, SBP08335091GA, SBP08104152GA, SBP08335030GA, SBP07413185GA, SBP08164463GA, SBP07373060GA, SBP08365276GA, SBP06280656GA, SBP08224701GA, SBP08114274GA, SBP08194535GA, SBP08405478GA, SBP08405471GA, SBP08385457GA, SBP08385462GA, SBP08385464GA, SBP08385446GA, SBP08385444GA, SBP08385443GA, SBP08385448GA, SBP08415533GA, SBP08415532GA, SBP08425546GA, SBP08425544GA, SBP08415499GA, SBP08425541GA, SBP08425555GA, SBP08425554GA, SBP08415496GA, SBP08415497GA, SBP08425553GA, SBP08415489GA, SBP08425550GA, SBP08415523GA, SBP08425569GA, SBP08415517GA, SBP08415515GA, SBP08415494GA, SBP08445598GA, SBP08425568GA, SBP08425570GA, SBP08425582GA, SBP08425567GA, SBP08445593GA, SBP08445611GA, SBP08455627GA, SBP08445608GA, SBP08455619GA, SBP08455643GA, SBP08475675GA, SBP08455634GA, SBP08475668GA, SBP08475663GA, SBP08475654GA, SBP08485711GA, SBP08475649GA, SBP08495730GA, SBP08475651GA, SBP08495752GA, SBP08495771GA, SBP08495750GA, SBP08505773GA, SBP08515836GA, SBP08505781GA, SBP08515840GA, SBP08515903GA, SBP08515900GA, SBP08495761GA, SBP08495756GA, SBP08515918GA, SBP08515925GA, SBP08515914GA, SBP08525975GA, SBP08525957GA, SBP08515948GA, SBP08525955GA, SBP09026018GA, SBP09026022GA, SBP08525963GA, SBP09026013GA, SBP08515947GA, SBP09036051GA, SBP08385461GA, SBP06521691GA, SBP05480037GA, SBP06140217GA / SBP08204594GA, SBP06160267GA, SBP06190362GA / SBP08204588GA, SBP07122132GA, SBP07403106GA, SBP07473532GA, SBP08094018GA, SBP06200394GA, 717933, 9011933, M2BV0021F, SBP06511552GA, SBP08294857GA, SBP08294933GA, SBR06120044GA, SBY07130180GA, SBY07360211GA, SBP06511555GA, SBP06340971GA, SBP06491460GA, C48R0044F, SBP07102027GA, SBP07122115GA, SBP07192300GA, SBP07122128GA, SBP06090174GA, SAC04380008GA, SAE05180093GA, SBP06371047GA, SBP07232538GA, SBP08194511GA, SBX06380017GA, SBX07220024GA, SBX08100045GA, SBY06230110GA, SBY06240113GA, SBY06470152GA, SBY06480154GA, SBY06490158GA, SBY07360210GA, SBP06230509GA, SBP06140216GA, SBP06190256GA, SBP06190332GA, SBP06210438GA, SBP07081986GA, SBP07122122GA, SBP07453464GA, SBP07483550GA, SBP07493604GA, SBP08104135GA, SBP08124342GA, SBP08365289GA, SBP08385409GA, SBP08475667GA, SBP08415529GA, SBP09026011GA, SBP06491456GA, SBP06491457GA, SBP06491464GA, SBP07282663GA, SBP07373044GA, SBP08375385GA, SBP08324972GA, SBP08335006GA, SBP08204620GA, SBP08415520GA, SBP06290743GA, SBP06501500GA, SBP08324976GA, SBP06180301GA, SBP06220456GA, SBP07041771GA, SBP07122125GA, SBP07413195GA, SBP08023771GA, SBP08104147GA, SBP08104150GA, SBP08485713GA, SBP06080168GA, SBP06371065GA, SBP06330868GA, SBP06451322GA, SBP06441295GA, SBP06160260GA, SBP07122130GA, SBP07061863GA, SBP07362961GA, SBP07423228GA, SBR07421143GA, SBP07403113GA, SBP08124390GA, SBP08093975GA, SBP08094067GA, SBP06090177GA, SAD05473249GA, SBP07092015GA, SBP08294935GA, SBY08260270GA, SBY07220206GA, SBP08415527GA, SBP06431234GA, SBP07332848GA, SBP08485718GA, SBX08150047GA and SBP08144418GA.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- Including states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, WA, WI, WY and DC and countries of UNITED KINGDOM , TAIWAN, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, QATAR, NEW ZEALAND, NETHERLANDS, KUWAIT, REPUBLIC OF KOREA, JORDAN, JAPAN, ITALY, IRELAND, GERMANY, FRANCE, FINLAND, ESTONIA, DENMARK, CANADA, BELGIUM, AUSTRIA and AUSTRALIA.
  • Description du dispositif
    GE Healthcare MUSE Cardiology Information Systems vs. 7.0, 7.0.1, 7.0.2, 7.1, 7.1.1. || The MUSE Cardiology Information System is intended to store, access and manage cardiovascular information on adult and pediatric patients.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
  • Source
    USFDA