Recall Z-1133-2013 ยท DQK Computer, Diagnostic, Programmable
GE Healthcare, LLC
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.
| Date | Apr 17, 2013 (initiated Jan 4, 2012) |
| Status | Terminated |
| Reason | GE Healthcare conducted a recall on the Muse v7 because incorrect medications were displayed on the MUSE, which could result in incorrect treatment. |
| Root cause | 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 | 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, NETH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050614 | MUSE CARDIOLOGY INFORMATION SYSTEM Ge Medical Systems Information Technologies, Apr 5, 2005 |
| K072502 | MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM Ge Medical Systems Information Technologies, Nov 19, 2007 |
| K083639 | MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE Ge Medical Systems Information Technologies, Feb 17, 2009 |