BEUDAMED
    FDA Recall Terminated

    Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to provide general inhalation anesthesia and ventilatory support.

    Recall: Z-1443-2013 · Initiated May 14, 2013

    Recall

    Recall Number
    Z-1443-2013
    Event Number
    65164
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    May 14, 2013
    Posted
    June 3, 2013
    Terminated
    March 12, 2014
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to provide general inhalation anesthesia and ventilatory support.

    Reason

    GE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 absorbent canister accessory used with Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 systems. Reusable CO2 absorbent canisters accessories may not seal properly.

    Action

    GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter April 30, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Fax back form was included with the letter requesting the consignees to complete and return.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, CT, ID, MK, MI, NJ, NY, OH, TN, TX, and VA, and the countries of INDIA, AUSTRALIA, BAHRAIN, BANGLADESH, BOLIVIA, BOSNIA & HERZEGOWINA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDONESIA, IRAQ,ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA,LEBANON, MALAYSIA, MEXICO, NETHERLAND,NEW ZEALAND, OMAN, PARAGUAY, PERU., PHILIPPINES, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, THAILAND, TURKEY, UNITED ARAB EMIRATES , UNITED KINGDOM, and VIET NAM.

    Quantity

    800