Device Recall GE Healthcare MUSE Cardiology Information Systems

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
  • Source
    USFDA