BEUDAMED
    FDA Recall Terminated

    DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500

    Recall: Z-1814-2010 · Initiated April 29, 2010

    Recall

    Recall Number
    Z-1814-2010
    Event Number
    55405
    Firm
    Ge Healthcare, Llc
    FEI Number
    2126677
    Product Code
    DPZ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    April 29, 2010
    Posted
    June 22, 2010
    Terminated
    December 3, 2013
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500

    Reason

    GE Healthcare has recently become aware that the TruSat Pulse Oximeter with external power supply does not comply with current safety standards. It is possible that the external power supply could leak electrical current. This current could cause third degree burns or an abnormal heart rhythm that, if untreated, could lead to death.

    Action

    Consignees were sent on 4/29/10 a GE Healthcare "Urgent Medical Device Correction" letter dated 4/22/10. The letter was addressed to Healthcare Administrator/Risk Manager, Chief of Nursing, Director of Biomedical Engineering, and Home Healthcare Provider. The letter included the Safety Issue, Affected Product Details, Product Correction, Safety Instructions and Contact Information.

    Distribution

    Worldwide distribution: USA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BANGLADESH,BELGIUM, BOLIVIA, BRAZIL, CANADA, INDIAN OCEAN TERRITORY, CHILE COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON LIBYAN ARAB JAMAHIRYA, LITHUANIA, MACEDONIA, MALAYSIA, MALTA, MEXICO, MOZAMBIQUE, NEPAL, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAK IA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM, ZAMBIA.

    Quantity

    28,442 units