GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 518
FDA device recall Z-2257-2013 · posted 2013-09-19 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain circumstances. This issue may impact patient safety.
- Action taken
- GE Healthcare sent an Important Product Information letter dated September 19, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. GE Healthcare has recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain circumstances. This issue may impact patient safety. The Contact Information (US 800-437-1171, Japan 0120-055-919, Other countries contact local GE Healthcare Service Representative).
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 179
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of : AL AZ, CA, CO, CT, FL, GA, IL, IN, MD,MI, MO, NJ, NY, NC, OK, PA, TX and WI., and the countries of : AUSTRIA, BELGIUM, CANADA, FINLA
- Date initiated
- 2012-09-20
- Date posted
- 2013-09-19
- Date terminated
- 2016-07-07
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SENO ADVANTAGE (K033400) | Ge Medical Systems W-400 | 2003-12-04 |