• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Muse v7

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Muse v7 see related information
Date Initiated by Firm January 04, 2012
Date Posting Updated April 17, 2013
Recall Status1 Terminated 3 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
-
-