Recall Z-1719-2009 ยท DQK Computer, Diagnostic, Programmable
GE Healthcare, LLC
GE Healthcare MUSE Cardiology Information Systems vs. 7.0, 7.0.1, 7.0.2, 7.1, 7.1.1. The MUSE Cardiology Information System is intended to store, access and manage cardiovascular information on adult and pediatric patients.
| Date | Aug 14, 2009 (initiated Feb 2, 2009) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of an issue resulting from a workflow situation related to the automated labeling of patient data in the MUSE Cardiology Information System. When a prior record has been confirmed with an invalid (default) patient identifier (PID), MUSE will accept future records with the same default PID as correct. If subsequent records don not contain a name, MUSE will pre-popu |
| Root cause | Software design |
| Action | GE Healthcare issued an "Urgent Medical Device Correction" letter dated October 13, 2008, addressed to Healthcare Administrator/Risk Manager, Cardiology Administrators and Head of Cardiology. The letter listed the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, Background Information and Contact Information. For further questions, contact GE Healthcare at 1-800-558-7044. Outside the US, please contact your local GE Healthcare Service Representative. |
| Quantity | 327 |
| Distribution | Worldwide Distribution -- Including states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, WA, WI, WY and DC and countries of UNITED KINGDOM , TAIWAN, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072502 | MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM Ge Medical Systems Information Technologies, Nov 19, 2007 |