Device Recall GE Healthcare, Seno Advantage 2.1 and 2.2 Workstations

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Radiology Devices

2

No

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, LEBANON, KOREA, JAPAN, ITALY, IRELAND, GERMANY, FRANCE, DENMARK, CANADA, BELGIUM AUSTRIA, AUSTRALIA FINLAND.

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 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.