BEUDAMED
    FDA Recall Terminated

    Spacelabs flat panel monitor, Model 91415-A

    Recall: Z-0269-04 · Initiated October 29, 2003

    Recall

    Recall Number
    Z-0269-04
    Event Number
    27598
    Firm
    Datex-Ohmeda, Inc.
    FEI Number
    3010157426
    Product Code
    DXJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 29, 2003
    Posted
    July 20, 2004
    Terminated
    September 17, 2004
    Address
    5150 220th AVE SE, Issaquah, WA, 98029

    Description

    Spacelabs flat panel monitor, Model 91415-A

    Reason

    Potential for power supply to fail resulting in failure of the audio (alarm tones) to fail.

    Action

    A letter dated October 31, 2003 was sent on October 29-31, 2003 to all US customers via FED-EX. An ORDER FORM accompanied the letter for consignees to request a replacement power supply or to indicate they did not have the affected power supply.

    Distribution

    The firm distributes to hospitals nationwide. The firm also distributes internationally.

    Quantity

    2734 units for domestic consignees and 1099 for international consignees