BEUDAMED
    FDA Recall Terminated

    Delta/Delta XL Monitors with Omega S Package

    Recall: Z-0582-2010 · Initiated November 9, 2009

    Recall

    Recall Number
    Z-0582-2010
    Event Number
    53875
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 9, 2009
    Posted
    December 29, 2009
    Terminated
    August 23, 2011
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Delta/Delta XL Monitors with Omega S Package

    Reason

    monitor is rebooting/resetting

    Action

    Draeger Medical Systems, Inc. issued and Urgent Medical Device Recall letter dated November 2009 to their affected customers informing them of the problem and a work around until software can be validated. A Technical Service Bulletin has been generated and distributed globally that instructs the affected International Drager subsidiaries to inform customers in their countries. For further information, contact Draeger Medical Systems, Inc. at 1-800-543-5047, extension 1-2349.

    Distribution

    The product was shipped to medical facilities in CA, CO, CT, ID, IN, KY, MS, NY, OK, and WI. The product was also shipped to United Arab Emirates, Argentina, Austria, Australia, Bosnia Herz, Belgium, Benin, Brunei Darussalam, Bolivia, Brazil, Belarus, Canada, Switzerland, Chile, China, Columbia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Egypt, Spain, Finland, France, Great Britain, Greece, Hong Kong, Croatia, Hungary, Ireland, India, Iran, Italy, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Lithuania, Latvia, Libya, Morocco, Mexico, Malaysia, Netherlands, Norway, Nepal, Oman, Poland, Portugal, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovak Republic, Thailand, Turkey, Taiwan, Ukraine, Venezuela, Vietnam, and South Africa.

    Quantity

    4,188 units