BEUDAMED
    FDA Recall Terminated

    LATITUDE Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.

    Recall: Z-1339-2013 · Initiated April 10, 2013

    Recall

    Recall Number
    Z-1339-2013
    Event Number
    65096
    Firm
    Boston Scientific CRM Corp
    FEI Number
    2124215
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    April 10, 2013
    Posted
    May 20, 2013
    Terminated
    November 26, 2013
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    LATITUDE Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.

    Reason

    Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3 because between March 4 and 27, 2013, a Siebel release caused ~5000 distributed PMR clinic faxes to display with illegible characters and not the required, Patient non-compliance information that was intended.

    Action

    Boston Scientific CRM Corp began re-faxing the 4,912 previously illegible PMR notifications on April 10, 2013 and completed on April 15, 2013, successfully fulfilling labeling expectations that these notifications be communicated to the clinic. For questions regarding this recall call 651-582-4000.

    Distribution

    Nationwide Distribution including DC and PR

    Quantity

    1