FDA-Device2014-05-07Class II
GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images.
GE Healthcare, LLC
Hazard
GE Healthcare has recently become aware of a potential safety issue due to higher than actual flow values reported on CardiacVX and CardiacVX Flow running on Advantage Workstation.
Sold states
Worldwide Distribution - USA including IN and Internationally to AUSTRALIA, CANADA, CHILE, FRANCE, ITALY, JAPAN, KOREA, KUWAIT, NEW ZEALAND, PANAMA, POLAND, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM,
Affected count
101 (1 US , 100 OUS)
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1511-2014Don't want to check this manually?
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