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Terminated

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.

FDA Recall Z-1133-2013 · Posted 2013-04-17

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeDQK
Date Initiated2012-01-04
Date Terminated2013-07-19
Product Quantity963

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083639MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWAREGe Medical Systems Information Technologies · 2009-02-17K072502MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEMGe Medical Systems Information Technologies · 2007-11-19K050614MUSE CARDIOLOGY INFORMATION SYSTEMGe Medical Systems Information Technologies · 2005-04-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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