BEUDAMED
    FDA Recall Terminated

    Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4

    Recall: Z-1409-2010 · Initiated March 19, 2010

    Recall

    Recall Number
    Z-1409-2010
    Event Number
    55190
    Firm
    Boston Scientific Neuromodulation Corporation
    FEI Number
    3006630150
    Product Code
    LGW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 19, 2010
    Posted
    April 16, 2010
    Terminated
    February 29, 2012
    Address
    25155 Rye Canyon Loop, Valencia, CA, 91355-5004

    Description

    Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4

    Reason

    Toshiba has determined that certain Sony battery packs installed in Toshiba portable computers can overheat, posing fire hazard to customers. Based on Toshiba's investigation with Sony Corporation, they concluded that the battery cells in specific manufacturing lots could be affected.

    Action

    In a letter dated March 19, 2010 Boston Scientific informed consignees that it determined that certain Sony battery packs installed in Toshiba portable computers can overheat, posing fire hazard to customers, and telling them that they may be in possession of an affected product. They were advised that a Boston Scientific representative will contact them to arrange for an inspection of the Clinician Programmer (SC-7150-4). Until they have determined if the battery pack is affected, consignees were told they can only use their Toshiba portable computer with the original AC adapter power cord supplied with that computer, and were asked to remove the battery pack until its status is determined. Included with the letter was a Reply Verification Tracking Form which consignees were asked to complete the form following the instructions on the form and return to Boston Scientific in the enclosed postage paid return envelope or fax it to (877) 856-3546 by March 31, 2010. If they experience any issues they were told to cease using the Clinician Programmer and contact Boston Scientific's 24-hour Patient Care Hotline at (866) 360-4747. Customers can also contact the Field Action team by phone at (866) 684-7504 or by fax at (877) 856-3546 if they had any questions.

    Distribution

    Domestically to AR, CA, CO, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NY, OH, OR, PA, PR, SC, TX, VA, WI Internationally: Italy

    Quantity

    62 units