BEUDAMED
    FDA Recall Terminated

    LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.

    Recall: Z-1096-2012 · Initiated December 19, 2011

    Recall

    Recall Number
    Z-1096-2012
    Event Number
    60945
    Firm
    Boston Scientific CRM Corp
    FEI Number
    2124215
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 19, 2011
    Posted
    February 23, 2012
    Terminated
    October 25, 2012
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.

    Reason

    Boston Scientific is conducting a recall involving the LATITUDE Patient Management System - Model 6488, software version 7.2 because patients are not able to perform setup. There is no risk to health associated with this issue.

    Action

    Beginning on December 19, 2011, for the patients that have attempted to set-up their communicators, Boston Scientific called the patients and their associated LATITUDE clinics to let them know that they can now complete the set-up.

    Distribution

    Nationwide Distribution, USA - including the states CA, MA, MI, NC, OK, PA, RI, TX, and WA.

    Quantity

    1