BEUDAMED
    FDA Recall Terminated

    Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.

    Recall: Z-0002-2007 · Initiated May 19, 2006

    Recall

    Recall Number
    Z-0002-2007
    Event Number
    35672
    Firm
    Guidant Corporation
    FEI Number
    2124215
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 19, 2006
    Posted
    October 12, 2006
    Terminated
    December 31, 2006
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.

    Reason

    Final software load did not occur prior to shipment of select programmers.

    Action

    Sales Representatives were asked to retrieve/return identified monitors.

    Distribution

    Nationwide distribution --- including states of AR, MI, PA

    Quantity

    8