GE Healthcare MUSE Cardiology Information Systems vs. 7.0, 7.0.1, 7.0.2, 7.1, 7.1.1. The MUSE Cardiology Information Sys
FDA device recall Z-1719-2009 · posted 2009-08-14 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 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
- Date initiated
- 2009-02-02
- Date posted
- 2009-08-14
- Date terminated
- 2014-01-16
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM (K072502) | Ge Medical Systems Information Technologies | 2007-11-19 |