BEUDAMED
    FDA Recall Terminated

    Tidal Wave 610, Refurbished, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care.

    Recall: Z-1289-2010 · Initiated November 19, 2009

    Recall

    Recall Number
    Z-1289-2010
    Event Number
    53869
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    CCK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 19, 2009
    Posted
    April 8, 2010
    Terminated
    December 8, 2016
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Tidal Wave 610, Refurbished, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care.

    Reason

    Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may crack and fail at/or inside the plug. Potential for burns or electrical shock.

    Action

    Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may crack and fail at/or inside plug. The issue affects medical device power cords equipped with a plug that has a prong and ground-pin insert design and a black plastic bridge connecting the terminal prongs on the plug ("taller bridge" design). Medical device power cords that do not have a black bridge connecting the terminal prongs on the plug are not affected. Urgent Medical Device Correction letters were sent to Distributors describing the problem and giving them instructions for notifying customers and actions to be taken. Customers are to visually inspect the affected cords, complete the Customer Reply Power Cord Order Form, and follow the instructions to dispose of affected cords. Further information or support concerning this issue can be obtained by contacting a Philips representative at 1-800-722-9377.

    Distribution

    Worldwide Distribution -- UNITED STATES, ALGERIA, ARGENTINA, Aruba, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, Denmark, ECUADOR, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAMAICA, JAPAN, KUWAIT, LEBANON, LIBYAN ARAB JAMAHIRIYA, MALAYSIA, MAURITIUS, MEXICO, NETHERLANDS, NETHERLANDS ANTILLES, NEW ZEALAND, NICARAGUA, NORWAY, PAKISTAN, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, RUSSIA, SAINT LUCIA, SAIPAN, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIET NAM, and VIRGIN ISLANDS.

    Quantity

    24