BEUDAMED
    FDA Recall Terminated

    Boston Scientific's LATITUDE Patient Management System: LATITUDE 6.1 Patient Management System Website Server software, Model 6488 for United States Server software, Model 6465 for European Union LATITUDE 6.2 Patient Management System Website Server software, Model 6441 for Canada Server software, Model 6442 for Australia / New Zealand Intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.

    Recall: Z-2052-2011 · Initiated January 10, 2011

    Recall

    Recall Number
    Z-2052-2011
    Event Number
    57744
    Firm
    Boston Scientific CRM Corp
    FEI Number
    2124215
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 10, 2011
    Posted
    April 26, 2011
    Terminated
    November 15, 2012
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    Boston Scientific's LATITUDE Patient Management System: LATITUDE 6.1 Patient Management System Website Server software, Model 6488 for United States Server software, Model 6465 for European Union LATITUDE 6.2 Patient Management System Website Server software, Model 6441 for Canada Server software, Model 6442 for Australia / New Zealand Intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.

    Reason

    Boston Scientific has determined that data within certain printed reports obtained from the LATITUDE Patient Management System may not be accurate, in that, the Most Recent Presenting Electrogram (MRP-EGM) for some of the selected patients may be either missing or incorrect.

    Action

    Consignees were sent a Boston Scientific "LATITUDE Medical Records Information" letter dated January 2011. The letter was addressed to "Dear Doctor". The letter described the problem and the product involved in the recall. The letter also included the Rate of Occurrence, Action and Further Information sections.

    Distribution

    Worldwide Distribution -- USA, including DC and PR, and countries of AUSTRALIA, CANADA, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, NETHERLANDS, NORWAY, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM.

    Quantity

    25,836