Recall Z-3012-2011 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
GE Healthcare, Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration, GE Healthcare 3000 North Grandview, Waukesha, WI 53188 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 physician, mammographic images displayed on
| Date | Aug 12, 2011 (initiated May 31, 2011) |
| Status | Terminated |
| Reason | GE Healthcare has become aware that patient mismatch could occur on some Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration. This issue may impact patient safety. When Seno Advantage workstation is synchronized with RIS using CCOW (an HL7 standard protocol designed to enable disparate applications to synchronize in real-time), the following issues could occur: 1. Two different |
| Root cause | Software design |
| Action | GE Healthcare sent a URGENT MEDICAL DEVICE CORRECTION letter to all affected customers dated May 31, 2011. The letter identified the product , the problem and the action needed to be taken by the customer. GE Healthcare will upgrade all affected workstations at no cost. A GE Healthcare service representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please call one of the following phone numbers: United States: 800 437 1171 Japan: 0120 - 055 - 919 For other countries, please contact your local GE Healthcare Service Re |
| Quantity | 391 |
| Distribution | Worldwide Distribution--USA (nationwide) including the states of: AZ, CA, CO, CT, FL, GA, HI, IL, IN, IA, LA, MD, MA, MI, MN, MO, MT, NE, NJ, NY, NC, OK, OR, PA, SC, TN,TX, and WI, and the countries of UNITED KINGDOM, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, PORTUGAL NORWAY, NEW ZEALAND, LUXEMBOURG, |
| FDA record | Open on fda.gov |