Regulations/Standards

The FDA Enforcement Report for the week of October 31 lists the ongoing Class II recall of GE Seno Advantage medical image review stations.

Originally recalled by the company on May 24, 2012, the recall involves the GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1, Seno Advantage 1.x, Seno Advantage 2.0, and Seno Advantage 2.1. The 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. Filmed images from all modalities may also be used as an element for diagnosis.

GE Healthcare became aware of an issue associated with the magnification images acquired on non-GE digital mammography systems and a 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 caregiver, this could lead to an overestimate of the size of the breast lesion. The measurement values for GE images are not affected.

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