FDA-Device2012-10-31Class II
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 modalit
GE Healthcare, LLC
Hazard
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
Sold states
Worldwide Distribution--USA (nationwide) including the states of CA, CO, CT, DC, FL, GA, KY,LA, MA, MO, NV, NJ, NY, NC, OH, OK, PA, SD, TN, TX, VA and WI., and the countries of UNITED KINGDOM, TUKEY, TAIWAN, SPAIN, SINGAPORE, SAUDI ARABIA, RUSSIA, PORTUGAL, NEW ZEALAND, NETHERLANDS, MEXICO, MALAYSIA, KOREA, JAPAN, ITALY, HUNGARY, GREECE, GERMANY, FRANCE, CHINA, CANADA, BRAZIL, AUSTRIA and ALGERIA.
Affected count
188
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0095-2013Don't want to check this manually?
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