FDA-Device2013-03-13Class II

GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast, easy, volume visualization of three dimensional structures imaged with a computed tomography (CT) or magnetic resonance (MR) system. It is dedicated to clinical and diagnostic applications in radiology, surgery, and trea

GE Healthcare, LLC
Hazard

Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis.

Sold states
Worldwide Distribution - USA including the states of AR, CA, CO, FL, GA, IL IN, IA, LA, MD, MA, MI, MN, MO, NJ, NM, NY, NC, OH, OK, PA, PR, SC, SD, TN, TX and VA. and the countries of ALGERIA, AUSTRALIA, AUSTRIA, ARGENTINA, BELARUS, CANADA, CHINA, CHILE, EGYPT CZECH REPUBLIC, FRANCE, FINLAND, GERMANY, GABON, HONG KONG, INDIA, IRELAND, ITALY KENYA, KOREA, JAPAN, MEXICO, NIGERIA, PHILIPPINES, PORTUGAL REPUBLIC OF MALTA, RUSSIAN FEDERATION SAUDI ARABIA, SPAIN SWITZERLAND, TURKEY, TAIWAN, TUNISIA, UNTIED KINGDOM and VENEZUELA.
Affected count
363
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast, easy, volume visualization of three dimensional structures imaged with a computed tomography (CT) or magnetic resonance (MR) system. It is dedicated to clinical and diagnostic applications in radiology, surgery, and treatment planning.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0901-2013

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