BEUDAMED
    FDA Recall Terminated

    Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope

    Recall: Z-2134-2016 · Initiated June 20, 2016

    Recall

    Recall Number
    Z-2134-2016
    Event Number
    74515
    Firm
    Karl Storz Endoscopy
    FEI Number
    3007475226
    Product Code
    FET
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 20, 2016
    Posted
    July 6, 2016
    Terminated
    January 5, 2017
    Address
    2151 E Grand Ave, El Segundo, CA, 90245-5017

    Description

    Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope

    Reason

    Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera head are used in conjunction with the DCI Video Mediastinocope and an electro-surgery generator (ESG).

    Action

    KARL STORZ sent an Customer Notification letter dated June 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. KARL STORZ has become aware become aware of a potential electrical interference issue when the lmage1 SPIES X-LINK and lmage1 SPIES D1 camera head are used in conjunction with the DCI Video Mediastinoscope and an electro-surgery generator (ESG). Customers are instructed to complete the attached acknowledgement Form and to return it to KARL STORZ. Customers with questions are instructed to contact Technical Support Dept. at (800) 421-0837, press 2, and then press 1.

    Distribution

    Worldwide Distribution - US Distribution to the states of : IL, NM, TX, MD, TN, PA, FL, KY, MO, NY, MN, DC, MA, WI, CT, MI, ID, CO, GA, NJ and AR., and to the countries of : Argentina, Australia, Belgium, Bulgaria, China, Germany, Finland, Great Britain, India, Italy and Japan.

    Quantity

    619 units total (90 units in US)