BEUDAMED
    FDA Recall Terminated

    Spacelabs Medical Flat Panel Display is a touchscreen display, 19-inch thin film transistor liquid crystal display (TFT-LCD). The PNs are 010-1619-00 and 010-1655-00, Models 94260-19 and 94256.

    Recall: Z-0620-2011 · Initiated March 20, 2009

    Recall

    Recall Number
    Z-0620-2011
    Event Number
    57370
    Firm
    Spacelabs Healthcare, Llc
    FEI Number
    3010157426
    Product Code
    DXJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 20, 2009
    Posted
    December 14, 2010
    Terminated
    June 13, 2011
    Address
    5150 220th Ave Se, Issaquah, WA, 98029-6834

    Description

    Spacelabs Medical Flat Panel Display is a touchscreen display, 19-inch thin film transistor liquid crystal display (TFT-LCD). The PNs are 010-1619-00 and 010-1655-00, Models 94260-19 and 94256.

    Reason

    The power supply of the Spacelabs Medical Flat Panel Display may fail, causing the display to go blank.

    Action

    Spacelabs Healthcare sent an URGENT: MEDICAL DEVICE RECALL Spacelabs Medical Flat Panel Power Supply PNs: 010-1619-00 & 010-1655-00 letter dated March 20, 2009 to US consignees. On March 27, 2009, Spacelabs sent the same recall letter with translation option to their international consignees.The letter stated the firm would be sending a replacement power supply. While waiting for the replacement of the power supply, Spacelabs Medical recommended their consignees brief the staff on the possibility of the display going blank to help prevent any adverse event from happening. The consignees were advised to dispose the old power supply per their premise protocol or local regulations. The consignees from US can contact Spacelabs Medical at 1-800-522-7025, #2 for Technical Support , and consignees outside the United States can call 1-425-657-7200 x5089 for any questions about the recall.

    Distribution

    Worldwide Distribution: USA in the following states: AK, AL, AR, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY, and including the following countries: AUSTRALIA, AUSTRIA, CANADA, Caribbean, CZECH REPUBLIC, EGYPT, ESTONIA, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, ISRAEL, ITALY, JORDAN, KUWAIT, LEBANON, MEXICO, NETHERLANDS, PAKISTAN, PANAMA, POLAND, PUERTO RICO, SAUDI ARABIA, SINGAPORE, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED KINGDOM, and VENEZUELA.

    Quantity

    2877 units in US and 731 units outside US