GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 app cd, Model Number 2026443-015
FDA device recall Z-1133-2013 · posted 2013-04-17 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 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, F
- Date initiated
- 2012-01-04
- Date posted
- 2013-04-17
- Date terminated
- 2013-07-19
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE (K083639) | Ge Medical Systems Information Technologies | 2009-02-17 |
| MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM (K072502) | Ge Medical Systems Information Technologies | 2007-11-19 |
| MUSE CARDIOLOGY INFORMATION SYSTEM (K050614) | Ge Medical Systems Information Technologies | 2005-04-05 |