BEUDAMED
    FDA Recall Terminated

    Clinician Workstation Software, product code 2M5042

    Recall: Z-0981-05 · Initiated March 10, 2005

    Recall

    Recall Number
    Z-0981-05
    Event Number
    31467
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    LNX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 10, 2005
    Posted
    July 13, 2005
    Terminated
    February 6, 2008
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Clinician Workstation Software, product code 2M5042

    Reason

    The medication administration results displayed in the 'View Results' link may be inaccurate.

    Action

    Urgent Device Correction recall letters dated 3/10/05 were sent to the direct accounts on the same date via first class mail. The letter describes the inaccuracies in the 'View Results' program, and informed the accounts that inaccurate information could lead to incorrect clinical decision-making, which could impact a patient''s medication treatment protocol. The accounts were requested to disable the 'View Results' link until a software upgrade is available, and to inform all clinical point of care users that the 'View Results' has been disabled and that the Manual Adminstration Record is to be used as the primary source of information for reviewing medication adminstration results. The accounts were instructed to contact their account executive and/or the Client Support Services at 1-877-835-2727 for instructions on how to disable the 'View Results' feature.

    Distribution

    Missouri, Massachusetts, Vermont, California and Canada.

    Quantity

    5 units