BEUDAMED
    FDA Enforcement Class II 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 · Reported May 29, 2013

    Enforcement

    Recall Number
    Z-1339-2013
    Event ID
    65096
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific CRM Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    FAX
    Report Date
    May 29, 2013
    Initiation Date
    April 10, 2013
    Classification Date
    May 20, 2013
    Termination Date
    November 26, 2013
    Address
    4100 Hamline Ave N, N/A, Saint Paul, MN, 55112-5700, United States

    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.

    Code Info

    n/a

    Distribution

    Nationwide Distribution including DC and PR

    Quantity

    1