BEUDAMED
    FDA Recall Terminated

    Boston Scientific, LATITUDE Patient Management System Communicator, Model 6476, Distributed by Boston Scientific, 4100 Hamline Avenue North, St Paul, MN 55112-5798 Boston Scientific, LATITUDE RF Communicator & Software, Model 6482.Distributed by Boston Scientific, 4100 Hamline Avenue North, St Paul, MN 55112-5798 LATITUDE Communicator REF 6468 (only distributed outside the US) 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-3283-2011 · Initiated August 1, 2011

    Recall

    Recall Number
    Z-3283-2011
    Event Number
    59686
    Firm
    Boston Scientific CRM Corp
    FEI Number
    2124215
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 1, 2011
    Posted
    September 28, 2011
    Terminated
    November 6, 2012
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    Boston Scientific, LATITUDE Patient Management System Communicator, Model 6476, Distributed by Boston Scientific, 4100 Hamline Avenue North, St Paul, MN 55112-5798 Boston Scientific, LATITUDE RF Communicator & Software, Model 6482.Distributed by Boston Scientific, 4100 Hamline Avenue North, St Paul, MN 55112-5798 LATITUDE Communicator REF 6468 (only distributed outside the US) 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

    A limited number of Model 6476, 6482, and 6468 (Not available in the US) LATITUDE Communicators are unable to authenticate, and thus cannot connect to the LATITUDE System. Customers are instead receiving Latitude Temporarily Unavailable (LTU) message.

    Action

    Boston Scientific CRM Corporation sent a " Dear Patient", letter dated August 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A new communicator is being shipped separately to you with a corrected security certificate that will allow it to be activated and function normally. 1. Please activate this new equipment at your convenience to begin home monitoring. Activation instructions are enclosed with the communicator. 2. We also ask that you return the original communicator previously delivered to you: " Place the original equipment in the shipping box used for the new equipment. " Pack newspaper or other filler around the equipment to prevent damage during shipping, and seal the box. " Enter your address in the FROM section of the prepaid Federal Express label, and apply the return label to the outside of the box directly over the original label. " Call Federal Express at 1.800.463.3339 to schedule a pick-up. We apologize for this inconvenience. If you have further questions, please call 1.866.484.3268.

    Distribution

    Worldwide Distribution -- (USA) nationwide including the states of AL, AK, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA,ME, MD, MA, MI, MN, MS, MO, MT, NE,NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI,SC, SD, TN, TX, UT, VA, WA, WV, WI, WY., and the countries of United Kingdom, France

    Quantity

    470