BEUDAMED
    FDA Recall Terminated

    Ultraview Universal Clinical Workstation Model 90385.

    Recall: Z-1007-04 · Initiated May 7, 2004

    Recall

    Recall Number
    Z-1007-04
    Event Number
    29038
    Firm
    Spacelabs Medical Inc.
    FEI Number
    3010157426
    Product Code
    DSI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 7, 2004
    Posted
    July 20, 2004
    Terminated
    April 8, 2006
    Address
    5150 220th Ave Se, Issaquah, WA, 98029

    Description

    Ultraview Universal Clinical Workstation Model 90385.

    Reason

    Potential for telemetry channels to drop off display.

    Action

    For all US customers, a Medical Device Correction letter was mailed on May 7, 2004 via courier instructing their customers to insure all monitored patients are displayed. The letter also instructed customers to move the printer to another central monitor as well as having a Field Service Engineer install new software when it becomes available. This letter was also mailed to international customers on May 14, 2004.

    Distribution

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

    Quantity

    142 units