BEUDAMED
    FDA Recall Terminated

    Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1, and 4.0.2.41.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Manufacture Dates: 4.0.2.38.1 06/15/07 4.02.39.2 06/29/07, 4.02.40.1 07/19/07, 4.02.41.1 08/20/07. The Result Reporting Interface is a highly versatile interface designed to electronically convey clinical laboratory orders and results for the SCC applications to other recipient information systems.

    Recall: Z-0069-2011 · Initiated October 5, 2007

    Recall

    Recall Number
    Z-0069-2011
    Event Number
    56278
    Firm
    SCC Soft Computer
    FEI Number
    1000307651
    Product Code
    LNX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 5, 2007
    Posted
    October 15, 2010
    Terminated
    October 19, 2010
    Address
    5400 Tech Data Drive, Clearwater, FL, 33760

    Description

    Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1, and 4.0.2.41.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Manufacture Dates: 4.0.2.38.1 06/15/07 4.02.39.2 06/29/07, 4.02.40.1 07/19/07, 4.02.41.1 08/20/07. The Result Reporting Interface is a highly versatile interface designed to electronically convey clinical laboratory orders and results for the SCC applications to other recipient information systems.

    Reason

    SCC Soft Computer, Clearwater, FL issued a Correction for Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.0.2.40.1, and 4.0.2.41.1 on 10/05/2007. A software anomaly in the result reporting interface caused result comments entered after an empty line not to be sent to the HIS system. This included interpretative comments, results, and normal range c

    Action

    SCC Soft Computer sent a RISK-TO-HEALTH NOTIFICATION TASK VERBIAGE dated October 5, 2007, through their Task Management System to all affected clients on October 17, 2007. The notice identified the product, the problem and the action clients should take to correct the problem. Clients were to acknowledge receipt of the task notice and to identify if the Workflow or functionality is not used and if they Agree to use alternative working solutions. Each client was asked to grant permission to load the required software to correct the issue. For any questions regarding this recall call (727) 789-0100.

    Distribution

    Worldwide Distribution - USA, including AL, CO, FL, GA, IN, KS, KY, MA, MO, NC, NH, NJ, NY, OH, PA, TN, and WA and the country of Canada

    Quantity

    35