BEUDAMED
    FDA Recall Terminated

    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: Z-1511-2014 · Initiated April 7, 2014

    Recall

    Recall Number
    Z-1511-2014
    Event Number
    68032
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 7, 2014
    Posted
    April 25, 2014
    Terminated
    May 29, 2014
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    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.

    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.

    Action

    GE Healthcare sent an Urgent Medical Device Correction" letter dated August 21,2013, to all affected consignees. The letter was addressed to Hospital Administrators /Risk Managers, Radiology Department Managers and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Customers were instructed until the issue is corrected on their system with the affected CardiacVX or CardiacVX Flow software for phase-contrast protocols customers use the fast CINE phase-contrast sequence with the magnitude weighting user CV option disabled. For directions on how to update user CV, please refer to the MR operator manual. If customers choose to perform imaging using magnitude weighting, do not utilize CardiacVX or CardiacVX flow for flow value calculations.with the affected product. Customers with questions were instructed to contact their local service representative. For questions regarding this recall call 262-513-4122.

    Distribution

    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,

    Quantity

    101 (1 US , 100 OUS)