GE Cardiac VX Cl II

Company: GE Healthcare LLC
Date of Enforcement Report:5/7/2014
Class lI:

PRODUCT

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

REASON
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.

RECALLING FIRM/MANUFACTURER
GE Healthcare LLC, Waukesha , WI on 4/7/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
101

DISTRIBUTION
Nationwide and Internationally

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