BEUDAMED
    FDA Recall Terminated

    Datex-Ohmeda AS/3 Anesthesia Delivery Unit An Anesthesia Gas Machine for composition of anesthetic breathing gas and manual or mechanical ventilation for patients undergoing anesthesia. Indicated for all persons that require inhalation anesthesia.

    Recall: Z-1634-2009 · Initiated October 30, 2008

    Recall

    Recall Number
    Z-1634-2009
    Event Number
    50800
    Firm
    GE Healthcare
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 30, 2008
    Posted
    July 30, 2009
    Terminated
    May 17, 2012
    Address
    9900 Innovation Drive, Wauwatosa, WI, 53226

    Description

    Datex-Ohmeda AS/3 Anesthesia Delivery Unit An Anesthesia Gas Machine for composition of anesthetic breathing gas and manual or mechanical ventilation for patients undergoing anesthesia. Indicated for all persons that require inhalation anesthesia.

    Reason

    GE Healthcare has received reports of breathing circuit or tubing misconnections of the Anesthesia Delivery Unit (ADU), that may impact patient safety.

    Action

    A GE Healthcare "Urgent Medical Device Correction" letter was sent to consignees on 1/16/09. The letter was addressed to Health Care Administrator, Chief of Anesthesia and Director of Clinical Engineering. The letter described the Safety Issue; Affected Product Details; Safety Instructions, which include clinical personnel being properly trained on the correct connections of breathing circuit tubing and proper execution of System Checkout according to the ADU URMs; Product Correction and Contact Information.

    Distribution

    USA including states of AL, AK, AZ, AR, CA, CO, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, and WI and countries of Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Bosnia & Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, England, Estonia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Iraq, Ireland, Isle of Man (UK), Israel, Italy, Japan, Jordan, Kazahkstan, Kuwait, Latin America, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Paraguay, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Yemen.

    Quantity

    2,087