GE Healthcare, LLC 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
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.
Products Sold
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.
GE Healthcare, LLC is recalling GE Healthcare MUSE Cardiology Information Systems vs. 7.0, 7.0.1, 7.0.2, 7.1, 7.1.1. The MUSE Cardi due to GE Healthcare has become aware of an issue resulting from a workflow situation related to the automated labeling of patient data in the MUSE Cardiolo. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
GE Healthcare has become aware of an issue resulting from a workflow situation related to the automated labeling of patient data in the MUSE Cardiology Information System. When a prior record has been confirmed with an invalid (default) patient identifier (PID), MUSE will accept future records with the same default PID as correct. If subsequent records don not contain a name, MUSE will pre-popu
Recommended Action
Per FDA guidance
GE Healthcare issued an "Urgent Medical Device Correction" letter dated October 13, 2008, addressed to Healthcare Administrator/Risk Manager, Cardiology Administrators and Head of Cardiology. The letter listed the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, Background Information and Contact Information. For further questions, contact GE Healthcare at 1-800-558-7044. Outside the US, please contact your local GE Healthcare Service Representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
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, DC
Page updated: Jan 10, 2026