Recall Z-2257-2013 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained
| Date | Sep 19, 2013 (initiated Sep 20, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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). |
| Quantity | 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, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, IRAQ, JAPAN, LEBANON, NORWAY, PORTUGAL, SPAIN, SWEDEN and TAIWA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033400 | SENO ADVANTAGE Ge Medical Systems W-400, Dec 4, 2003 |