BEUDAMED
    FDA Recall Terminated

    Ultraview Universal Clinical Workstation System Model 90385.

    Recall: Z-0422-05 · Initiated January 7, 2005

    Recall

    Recall Number
    Z-0422-05
    Event Number
    30797
    Firm
    Spacelabs Medical Incorporated
    FEI Number
    3010157426
    Product Code
    DXJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 7, 2005
    Posted
    January 25, 2005
    Terminated
    January 17, 2011
    Address
    5150 220th Ave Se, Issaquah, WA, 98029-6834

    Description

    Ultraview Universal Clinical Workstation System Model 90385.

    Reason

    Weakness of the swivel base for the universal clinical workstation may result in the unit falling from its mounted position endangering users and patients.

    Action

    All US customers were sent a Medical Device Recall letter on 1/7/2005 describing how to examine monitors for the defect and to discontinue use of any suspect unit s until examintaion by a Field Service Engineer . International customers will be notified via email or letter on 1/14/2005. Follow up contact by Customer Support and Global Support is planned for any customer not responding with a FAX-back form.

    Distribution

    The firm completed a survey of their customer records and determined a total of 12,306 units were installed from January of 1994 through December of 1997. 7,601 units were originally sold to 767 US accounts and 4,705 units were sold to 102 international accounts. The firm estimates approximately 3000 units worldwide are still in operation with the Revision M or earlier base.

    Quantity

    12,306 devices with this base style.