FDA-Device2013-02-06Class II
AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.
GE Healthcare, LLC
Hazard
It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated.
Sold states
Worldwide Distribution - USA including AL, CT, FL, IL, MA, MO, NJ, NY, PA, TX VA, WA, WI and Internationally to TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SOUTH AFRICA, NIGERIA, MALAYSIA, KOREA, JAPAN, INDIA, GERMANY, FRANCE, EGYPT, DENMARK, CHINA, CHILE, CANDA, BRAZIL, AUSTRIA, and GREAT BRITAIN.
Affected count
65
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0754-2013Don't want to check this manually?
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