BEUDAMED
    FDA Recall Terminated

    Fresh Gas Control (A-FGC1) Unit, a component of the S/5 Anesthesia Delivery Unit. The Anesthesia Delivery Unit is designed to mix and dose respiratory gases and to ventilate the patient. The delivery unit is the basis for a flexible anesthesia system with full monitoring and data management capabilities.

    Recall: Z-1196-06 · Initiated March 22, 2006

    Recall

    Recall Number
    Z-1196-06
    Event Number
    34631
    Firm
    GE Healthcare
    FEI Number
    2183066
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 22, 2006
    Posted
    July 12, 2006
    Terminated
    May 29, 2007
    Address
    3030 Ohmeda Drive PO Box 7550, zip 53707-7550, Madison, WI, 53718

    Description

    Fresh Gas Control (A-FGC1) Unit, a component of the S/5 Anesthesia Delivery Unit. The Anesthesia Delivery Unit is designed to mix and dose respiratory gases and to ventilate the patient. The delivery unit is the basis for a flexible anesthesia system with full monitoring and data management capabilities.

    Reason

    There exists the possibility that the ADU Fresh Gas Control unit (A-FGC1) can shut off during normal handling of the anesthesia machine and result in no anesthetic agent output.

    Action

    An Urgent Medical Device Correction letter dated March 21, 2006, was sent to customers. It warns of the potential for no anesthetic agent output. The letter contains short term recommendations for use of the device until a GE Healthcare representative contacts the facility to schedule a vist and implelment corrective action.

    Distribution

    World wide-(including the States of IA, CA, MI, FL, MI, TX, IL, WI, OH, and countries of Finland, Singapore, Austria, South Africa, Sweden, Israel, Norway, Taiwan, Germany, Turkey, Portugal, Italy, Switzerland, Great Britain, and France

    Quantity

    62