Z-1719-2009

GE Healthcare MUSE Cardiology Information Systems vs. 7.0, 7.0.1, 7.0.2, 7.1, 7.1.1. The MUSE Cardiology...

Name: Z-1719-2009 GE Healthcare MUSE Cardiology Information Systems vs. 7.0, 7.0.1, 7.0.2, 7.1, 7.1.1. The MUSE Cardiology...
Creator: GE Healthcare, LLC
Published: 2009-02-02
License: https://open.fda.gov/license/

GE Healthcare / initiated 2009-02-02 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of 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... on 2009-02-02. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1719-2009
Status: Terminated
Initiated: 2009-02-02
Posted: 2009-08-14
Terminated: 2014-01-16
Recalling firm: GE Healthcare
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.
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: 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
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 327
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 codes and lots: 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 code DQK

K072502Class IIModification to: Muse Cardiology Information SystemGe Medical Systems Information Technologies / cleared 2007-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)