BEUDAMED
    FDA Recall Terminated

    Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit.

    Recall: Z-2039-2014 · Initiated June 25, 2014

    Recall

    Recall Number
    Z-2039-2014
    Event Number
    68646
    Firm
    Karl Storz Endoscopy
    FEI Number
    3007475226
    Product Code
    LMD
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 25, 2014
    Posted
    July 10, 2014
    Terminated
    January 13, 2015
    Address
    2151 E Grand Ave, El Segundo, CA, 90245-5017

    Description

    Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit.

    Reason

    KARL STORZ Endoscopy-America is recalling the Essential NEO because the connected power cable could potentially become overheated and result in smoke being generated and the cessation of function of the peripheral that the cable is connected to.

    Action

    Storz sent an Safety Alert letter dated June 25, 2014, to all customers who purchased the Essential NEO. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the attached Acknowledgement/Response Form with contact information and return to KARL STORZ. Customers with questions are instructed to contact KARL STORZ' Technical Support Department at (800) 421-0837, option 3, then option 4.

    Distribution

    Nationwide Distribution including the states of: AL, AZ, CA, CO, CT, District of Columbia, DE, FL, GA, HI, IA, IL, IN, KY, LA, MX, MS, MD, MI, MA, MO, MN. NM, NV, NJ, NY, NC, NE, OK, OH, PA, SC, SD, TX, UT, VA, WI and WA., and Internationally to Canada.

    Quantity

    968 units