Recall Z-0476-2011 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1
| Date | Nov 26, 2010 (initiated Aug 28, 2009) |
| Status | Terminated |
| Reason | The measurement values provided by the GE Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography systems. If not noticed by the caregiver, this could lead to an overestimate of the size of the breast lesion that may impact patient treatment and safety. The measurement values for GE images are not affected. |
| Root cause | Software design |
| Action | GE Healthcare issued "Urgent Medical Device Correction" letters dated August 28, 2009 or August 31, 2009 to either Seno Advantage Customers (Hospital Administrators/Risk Mangers, Radiology Department Managers), and Image Diagnostic Customers (Hospital Administrators/Risk Managers, Radiology Department Managers). The letters described the Safety Issue, Affected Product Details, safety Instructions, Product correction and Contact Information. GE will linstall new software with the release of Field Modification Instruction 12129. Customers can contact GE Healthcare about this issue at 800-437-11 |
| Quantity | 2514 |
| Distribution | Worldwide Distribution: USA in the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI,MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY, and to the countries of UNITED KINGDOM, TURKEY, TAIWAN, SWITZERLAND |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033400 | SENO ADVANTAGE Ge Medical Systems W-400, Dec 4, 2003 |