BEUDAMED
    FDA Recall Terminated

    GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance Display Unit with SW version 3.x and 4.11; identification numbers 1505-9000-000 and M1057699 (upgrade). Datex-Ohmeda, Inc., a General Electric Company, doing business as GE Healthcare, P.O. Box 7750, Madison, WI 53707-7550, USA, www.gehealthcare.com.

    Recall: Z-0784-2007 · Initiated February 2, 2007

    Recall

    Recall Number
    Z-0784-2007
    Event Number
    37105
    Firm
    Datex Ohmeda, Inc
    FEI Number
    2183066
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 2, 2007
    Posted
    May 10, 2007
    Terminated
    October 16, 2008
    Address
    3030 Ohmeda Drive PO Box 7550, zip 53707-7550, Madison, WI, 53707-7550

    Description

    GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance Display Unit with SW version 3.x and 4.11; identification numbers 1505-9000-000 and M1057699 (upgrade). Datex-Ohmeda, Inc., a General Electric Company, doing business as GE Healthcare, P.O. Box 7750, Madison, WI 53707-7550, USA, www.gehealthcare.com.

    Reason

    There are two unique conditions with the Engstrom Carestation that require corrective action. These include an anomaly in the control of the safety relief valve and a situation where the display unit may reset.

    Action

    Device Correction Letter to customers was mailed on 2/2/07 giving information about the correction and a short term recommendation until version 4.15 could be installed by a GE representative who would be contacting the customer.

    Distribution

    GA, RI, WI, TX. Foreign - AUSTRALIA, BRUNEI DARUSSALAM, BRAZIL, COLOMBIA, COSTA RICA, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, INDIA, ITALY, KOREA, MEXICO, MALAYSIA, PHILIPPINES, SAUDI ARABIA, SWEDEN, SINGAPORE, GERMANY.

    Quantity

    446