BEUDAMED
    FDA Recall Terminated

    SoftWeb version 4.0.4.10.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Manufacture Date: 05/16/2006.

    Recall: Z-0099-2011 · Initiated June 8, 2006

    Recall

    Recall Number
    Z-0099-2011
    Event Number
    56282
    Firm
    SCC Soft Computer
    FEI Number
    1000307651
    Product Code
    LNX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 8, 2006
    Posted
    October 20, 2010
    Terminated
    November 3, 2010
    Address
    5400 Tech Data Drive, Clearwater, FL, 33760

    Description

    SoftWeb version 4.0.4.10.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Manufacture Date: 05/16/2006.

    Reason

    If a case number is re-used in SoftWeb with SoftPath, the SoftPath case is linked to the original MRN in SoftWeb. This causes SoftPath cases being linked to the wrong patient in SoftWeb. Incorrect results on the patient with original MRN and no results on the patient with the second MRN (and the reused case number) are displayed in SoftWeb Results Query. SCC Soft Computer issued a Correction for

    Action

    SCC Soft Computer issued a Risk-to-Health notification with Client Notification Verbiage to the affected client using SCC Soft Computer's proprietary Task Management System on June 8, 2006. SCC recommended SoftPath/SoftWeb users NOT re-use SoftPath case numbers when cases are cancelled. The generic option setting "Specimen Registration - Standard Settings - Minimum Time to Reactivate Case Number" should be set to "0" so the user is not prompted to reuse the same case number. Client was asked to acknowledge receipt of the task and grant permission to load the required software correction.

    Distribution

    Nationwide Distribution: 1 hospital in Alaska.

    Quantity

    1