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U.S. Department of Health and Human Services

Class 2 Device Recall Muse v7

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 Class 2 Device Recall Muse v7 see related information
Date Posted April 17, 2013
Recall Status1 Terminated on July 19, 2013
Recall Number Z-1133-2013
Recall Event ID 64748
510(K)Number K050614  K072502  K083639 
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 app cd, Model Number 2026443-015: MUSE 7.0.2 app cd, Model number 2026443-017: MUSE 7.1 app cd, Model number 2026443-029:MUSE 7.1.1 A app cd, and Model Number 2026443-031: MUSE 7.1.1 app cd.

Intended to store, access and manage cardiovascular information on adult and pediatrics patients.
Code Information M_4
LOCAL_TEAM_5
LOCAL_TEAM_6
LOCAL_TEAM_7
LOCAL_TEAM_8
SBP05500051GA
SBP05520081GA
SBP06090174GA
SBP06090183GA
SBP06330882GA
SBP07122128GA
SBP07373047GA
SBP07423286GA
SBP08013762GA
SBP08194525GA
SBP08254779GA
SBP09236548GA
SBP07212446GA
SBP07282634GA
SBP07312790GA
SBP07423239GA
SBP07493608GA
SBP08104166GA
SBP09186476GA
SBP09186477GA
SBP09467322GA
SBP09477384GA
SBP09477393GA
SBP09497472GA
SBP10478600GA
SBP10498686GA
SBP11158997GA
SBP11339436GA
SBP11339438GA
SBP11459581GA
SBP06200386GA
SBP08244736GA
SBP06150229GA
SBP06150246GA
SBP07122081GA
SBP07122082GA
SBP07122083GA
SBP07340978GA
SBP10328405GA
LOCAL_TEAM_27
LOCAL_TEAM_28
LOCAL_TEAM_49
SBP05520080GA
SBP06180298GA
SBP06210439GA
SBP06280647GA
SBP06280672GA
SBP06371060GA
SBP06491460GA
SBP07021752GA
SBP07041771GA
SBP07041772GA
SBP07041805GA
SBP07071979GA
SBP07383076GA
SBP07493609GA
SBP08114268GA
SBP08214660GA
SBP08375321GA
SBP08485709GA
SBP09116204GA
SBP09186475GA
SBP09477436GA
SBP10248110GA
SBP10258213GA
SBP06340971GA
SBP07403106GA
SBP09146355GA
SBP09357020GA
SBP06511555GA
SBP10278234GA
SBP10398546GA
SBP05520136GA
SBP06511552GA
SBP07061826GA
SBP07362930GA
SBP09186459GA
SBP09356977GA
SBP09397202GA
SBP09427223GA
SBP10107754GA
SBP10288258GA
SBP06521691GA
SBP07453383GA
SBP08244719GA
SBP11038747GA
LOCAL_TEAM_29
LOCAL_TEAM_43
LOCAL_TEAM_44
SBP09236555GA
SBP11098884GA
SBP05480037GA
SBP05520122GA
SBP06140217GA
SBP06160267GA
SBP06190362GA
SBP06391136GA
SBP07122132GA
SBP07473532GA
SBP08094018GA
SBP08515917GA
SBP09126285GA
SBP10278228GA
SBP10278231GA
SBP08485713GA
SBP09236564GA
SBP06200383GA
SBP06360995GA
SBP06391131GA
SBP06431209GA
SBP07061866GA
SBP08365258GA
SBP08385461GA
SBP08405486GA
SBP11048794GA
SBP11128953GA
SBR09152475GA
SBX06250014GA
SBX07380027GA
SBX08310050GA
SBY06360131GA
SBP09367089GA
SBP10388516GA
LOCAL_TEAM_46
SBP06140216GA
SBP06160263GA
SBP06190339GA
SBP06210438GA
SBP07081986GA
SBP07122122GA
SBP07453376GA
SBP07473530GA
SBP07483558GA
SBP07493604GA
SBP08104135GA
SBP08124342GA
SBP08365289GA
SBP08385394GA
SBP08385409GA
SBP08415498GA
SBP08445596GA
SBP08475667GA
SBP09026011GA
SBP09086175GA
SBP09086177GA
SBP09086183GA
SBP09116205GA
SBP09126277GA
SBP09477419GA
SBP09497449GA
SBP09497455GA
SBP09497463GA
SBP10067688GA
SBP10077714GA
SBP10077734GA
SBP10248099GA
SBP10248117GA
SBP10378503GA
SBP11128936GA
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall
GE Healthcare conducted a recall on the Muse v7 because incorrect medications were displayed on the MUSE, which could result in incorrect treatment.
FDA Determined
Cause 2
Software design
Action Consignee letters were not sent for this recall. GE Healthcare's recall strategy was to update all affected systems that were distributed. Updating of the devices was carried out from February 2012 to August 2012 by GE Field personnel.
Quantity in Commerce 963
Distribution Worldwide Distribution -- USA, including all states except ME, and the U.S. Virgin Islands; and, the countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, MALAYSIA, NETHERLAND, NEW ZEALAND, NORWAY, PHILIPPINES,S QATAR, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
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