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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 Serial Number
SBP05450003GA
SBP05450009GA
SBP05500067GA
SBP06100195GA
SBP06110200GA
SBP06110203GA
SBP06160274GA
SBP06170288GA
SBP06180296GA
SBP06180306GA
SBP06180308GA
SBP06190316GA
SBP06190326GA
SBP06190329GA
SBP06190330GA
SBP06200371GA
SBP06200377GA
SBP06230507GA
SBP06230512GA
SBP06250577GA
SBP06260614GA
SBP06260619GA
SBP06280624GA
SBP06280626GA
SBP06280629GA
SBP06280637GA
SBP06280653GA
SBP06290744GA
SBP06290748GA
SBP06290758GA
SBP06290768GA
SBP06300778GA
SBP06300789GA
SBP06310812GA
SBP06310814GA
SBP06330820GA
SBP06330824GA
SBP06330838GA
SBP06330841GA
SBP06330853GA
SBP06330873GA
SBP06330878GA
SBP06340958GA
SBP06340959GA
SBP06360974GA
SBP06360979GA
SBP06360983GA
SBP06361019GA
SBP06371040GA
SBP06371055GA
SBP06371058GA
SBP06371061GA
SBP06391095GA
SBP06391100GA
SBP06411137GA
SBP06411147GA
SBP06421164GA
SBP06421167GA
SBP06421169GA
SBP06421171GA
SBP06421183GA
SBP06421189GA
SBP06431228GA
SBP06441246GA
SBP06441251GA
SBP06441277GA
SBP06441279GA
SBP06441282GA
SBP06441296GA
SBP06441306GA
SBP06441312GA
SBP06441319GA
SBP06451321GA
SBP06451335GA
SBP06451337GA
SBP06451340GA
SBP06481394GA
SBP06481398GA
SBP06481421GA
SBP06491463GA
SBP06491466GA
SBP06491469GA
SBP06491472GA
SBP06501503GA
SBP06501507GA
SBP06511545GA
SBP06511569GA
SBP06511571GA
SBP06511579GA
SBP06511615GA
SBP06511621GA
SBP06521635GA
SBP06521648GA
SBP06521689GA
SBP06521693GA
SBP06521694GA
SBP06521708GA
SBP06521710GA
SBP06521711GA
SBP07021747GA
SBP07021755GA
SBP07041777GA
SBP07041783GA
SBP07041791GA
SBP07051813GA
SBP07061846GA
SBP07061860GA
SBP07061871GA
SBP07061877GA
SBP07061887GA
SBP07061892GA
SBP07061929GA
SBP07071968GA
SBP07081995GA
SBP07082002GA
SBP07092008GA
SBP07092009GA
SBP07102056GA
SBP07122076GA
SBP07122079GA
SBP07122131GA
SBP07122134GA
SBP07122137GA
SBP07122144GA
SBP07122148GA
SBP07132155GA
SBP07142179GA
SBP07142194GA
SBP07142196GA
SBP07142197GA
SBP07152207GA
SBP07152209GA
SBP07152212GA
SBP07152226GA
SBP07152230GA
SBP07152233GA
SBP07152238GA
SBP07162252GA
SBP07182285GA
SBP07182291GA
SBP07182294GA
SBP07192309GA
SBP07192310GA
SBP07192314GA
SBP07192324GA
SBP07192328GA
SBP07192342GA
SBP07192351GA
SBP07202352GA
SBP07202353GA
SBP07202354GA
SBP07202362GA
SBP07212378GA
SBP07212382GA
SBP07212392GA
SBP07212397GA
SBP07212403GA
SBP07212443GA
SBP07212458GA
SBP07212461GA
SBP07212466GA
SBP07222473GA
SBP07222480GA
SBP07232516GA
SBP07232520GA
SBP07232552GA
SBP07232554GA
SBP07232557GA
SBP07232561GA
SBP07232568GA
SBP07232572GA
SBP07242590GA
SBP07252622GA
SBP07282636GA
SBP07282641GA
SBP07282654GA
SBP07282656GA
SBP07282658GA
SBP07282683GA
SBP07282686GA
SBP07282698GA
SBP07292710GA
SBP07292713GA
SBP07312786GA
SBP07312794GA
SBP07312797GA
SBP07312799GA
SBP07312807GA
SBP07332825GA
SBP07342912GA
SBP07362914GA
SBP07362917GA
SBP07362923GA
SBP07362928GA
SBP07362937GA
SBP07362960GA
SBP07372985GA
SBP07372997GA
SBP07373010GA
SBP07373013GA
SBP07373014GA
SBP07373020GA
SBP07373048GA
SBP07373054GA
SBP07373065GA
SBP07383074GA
SBP07383087GA
SBP07393099GA
SBP07403124GA
SBP07403134GA
SBP07403141GA
SBP07413155GA
SBP07413172GA
SBP07413174GA
SBP07413179GA
SBP07413188GA
SBP07423229GA
SBP07423234GA
SBP07423250GA
SBP07423258GA
SBP07423264GA
SBP07423297GA
SBP07443322GA
SBP07453354GA
SBP07453371GA
SBP07453373GA
SBP07453381GA
SBP07453389GA
SBP07453396GA
SBP07453397GA
SBP07453444GA
SBP07453451GA
SBP07453452GA
SBP07453461GA
SBP07463470GA
SBP07463476GA
SBP07463479GA
SBP07463493GA
SBP07463497GA
SBP07473519GA
SBP07473521GA
SBP07473523GA
SBP07483554GA
SBP07493576GA
SBP07493583GA
SBP07493600GA
SBP07493618GA
SBP07503627GA
SBP07503639GA
SBP07503660GA
SBP07513686GA
SBP07513711GA
SBP07513719GA
SBP07513739GA
SBP08013758GA
SBP08023767GA
SBP08023779GA
SBP08053793GA
SBP08053799GA
SBP08053810GA
SBP08063834GA
SBP08063838GA
SBP08063841GA
SBP08063844GA
SBP08073929GA
SBP0809395
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
262-513-4122
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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