BEUDAMED
    FDA Recall Terminated

    DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 (GE Healthcare)

    Recall: Z-3206-2011 · Initiated April 8, 2011

    Recall

    Recall Number
    Z-3206-2011
    Event Number
    57889
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    DPZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 8, 2011
    Posted
    September 14, 2011
    Terminated
    March 4, 2016
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 (GE Healthcare)

    Reason

    The plastic enclosure on the external power supply of the TruSat Pulse Oximeter is prone to breakage, and overheating. The issue may impact patient or user safety. Potential for system or components to start on fire or explode (general case).

    Action

    On 4/8/11 GE Healthcare sent consignees an "Urgent Medical Device Correction" letter dated March 30, 2011. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, Director of Biomedical Engineering & Home Healthcare Provider. The letter listed the Safety Issues, Safety Instructions, Affected Product Details, Product Correction and Contact Information.

    Distribution

    Worldwide distribution: USA, ZAMBIA, VIETNAM, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, UGANDA, TURKEY, TUNISIA, TRINIDAD & Tobago, THAILAND, UNITED REPUBLIC OF TANZANIA, PROVINCE OF CHINA TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SUDAN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, QATAR, PORTUGAL, POLAND, PHILIPPINES, PERU, PANAMA, OMAN, NORWAY, NICARAGUA, NEW ZEALAND, NETHERLANDS, NEPAL, MOZAMBIQUE, MEXICO, MALTA, MALAYSIA, MACEDONIA, LITHUANIA, LIBYAN ARAB JAMAHIRIYA, LEBANON, LATVIA, KUWAIT, REPUBLIC OF KOREA, KENYA, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, HUNGARY, HONG KONG, HONDURAS, GUATEMALA, GUADELOUPE, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, KOREA, EL SALVADOR, EGYPT, ECUADOR, DENMARK, CZECH REPUBLIC, CYPRUS, CROATIA, COSTA RICA, COLOMBIA, CHINA, CHILE , CANADA, BRITISH INDIAN OCEAN TERRITORY, BRAZIL, BOLIVIA, BENNIN, BELGIUM, BANGLADESH, BAHAMAS, AUSTRIA, AUSTRALIA, ARGENTINA, and ALGERIA.

    Quantity

    31,846