BEUDAMED
    FDA Recall Terminated

    Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science).

    Recall: Z-1757-2010 · Initiated March 30, 2009

    Recall

    Recall Number
    Z-1757-2010
    Event Number
    51812
    Firm
    Cardiac Science Corporation
    FEI Number
    2112020
    Product Code
    IOL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 30, 2009
    Posted
    June 4, 2010
    Terminated
    January 10, 2012
    Address
    3303 Monte Villa Pkwy, Bothell, WA, 98021-8969

    Description

    Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science).

    Reason

    28 stress and rehab treadmills manufactured between September 2006 and January 2009 may not have received adequate electrical safety testing prior to being shipped from the factory. If these components break down in the field, a patient or operator could be exposed to excess touch currents on the surface of the product. Because safety testing may not have allowed for complete evaluation of the el

    Action

    On April 3, 2009 the recalling firms notified consignees by certified letter to domestic customers and via FedEx to international customers with delivery confirmation signature required. Customers were advised to remove treadmill from service until it is tested by a Field Service Engineer. For customers with questions or those that have not already scheduled a service call with Cardiac Science Field Service Engineers, please contact the firm at 1.800.426.0337, option 1.

    Distribution

    Distributed domestically (including Puerto Rico) to 20 end-user accounts and 2 distributor accounts; Distributed internationally to: Canada, Mexico, Portugal, and Saudi Arabia.

    Quantity

    28 treadmills