BEUDAMED
    FDA Recall Terminated

    Giraffe OmniBed and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer.

    Recall: Z-1051-2013 · Initiated January 8, 2013

    Recall

    Recall Number
    Z-1051-2013
    Event Number
    64189
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    FMZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 8, 2013
    Posted
    April 5, 2013
    Terminated
    July 10, 2013
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Giraffe OmniBed and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer.

    Reason

    Neonatal beds and incubator display boards may randomly overwrite stored information and radiant heater and oxygen set points upon power up or recovery from a power failure.

    Action

    GE Healthcare sent an "Urgent Medical Device Correction" letter, dated January 8, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were given the safety issue and instructions for continued use of the Giraffe OmniBed and Incubators, as well as given the affected product details. GE Healthcare will correct all affected Giraffe Incubators and Giraffe OmniBeds at no cost, and will contact customers to arrange for this correction. If customers have any questions or concerns regarding this notification, please call: United States: 1-800-345-2700. For other countries, please contact your local GE Healthcare Service Representative.

    Distribution

    Worldwide Distribution -- USA in the states of AR ,CA, CO, DC, FL, GA, HI, ID, IL, IN, KS, MA, MD, MI, MO, MS, NC, NE, NJ, NY, NV, OH, PA, TN, TX, VA, WA, WI, and WV, and the countries of Arab Emirates, Albania, Australia, Belgium, Brazil, Canada, Chile, China, Croatia, Czech., Denmark, Ecuador, Estonia, Finland, France, Germany, Hungary, Italy ,Korea, Kurdistan, Lebanon, Macedonia, Malaysia, Mexico, Norway, Oman, Poland, Russia, San Salvador, Saudi Arabia, Singapore, South Africa, Sweden, Turkey, Uruguay, Venezuela, and United Kingdom.

    Quantity

    679 units