Company: GE Healthcare LLC
Date of Enforcement Report:5/7/2014
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.
Recall Number Z-1511-2014
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.
GE Healthcare LLC, Waukesha , WI on 4/7/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally