Recall Z-0125-2013 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 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.
| Date | Oct 24, 2012 (initiated May 24, 2012) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potential miscalculation of size. |
| Root cause | Software design |
| Action | Consignees were sent on 5/24/12 a GE Healthcare "Urgent Medical Device Correction" letter dated May 23, 2012. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, and Product Correction. Customers should verify if their workstation is affected. GE Healthcare will correct all affected workstations by providing a software upgrade and Operator Manual update. A GE Healthcare service representative will contact you to arrange this corr |
| Quantity | 12 |
| Distribution | Worldwide Distribution -- USA (nationwide) including states of: CA, CT, NY, TX, and MS and countries of TAIWAN, ITALY, CANADA, and BAHRAIN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033400 | SENO ADVANTAGE Ge Medical Systems W-400, Dec 4, 2003 |