GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: 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 the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.

GE Healthcare has become aware of an issue associated with the magnification images acquired on non-GE digital mammography systems and your Seno Advantage Workstation that may impact patient safety. The measurement values provided by the Seno Advantage Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography systems. If not noticed by the caregiv

GE Healthcare sent a Urgent Medical Device Correction letter dated May 23, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. GE Healthcare will install new software to correct this issue with the release of Field Modification Instruction (FMI) 12129 in the near future. This correction will not affect the performance or any other functionality of your current equipment. A GE Healthcare service representative will contact you to arrange for this modification. This activity will be performed at no cost to you. 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 Representative.