BEUDAMED
    FDA Recall Terminated

    SoftMic Versions 4.0.4.7, 4.5.1.3. Version 4.0.4.7 Manufactured 02/03/2010. Version 4.5.1.3 Manufactured 03/18/2010. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.

    Recall: Z-0088-2011 · Initiated July 19, 2010

    Recall

    Recall Number
    Z-0088-2011
    Event Number
    56851
    Firm
    SCC Soft Computer
    FEI Number
    1000307651
    Product Code
    LNX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 19, 2010
    Posted
    October 19, 2010
    Terminated
    July 16, 2012
    Address
    5400 Tech Data Drive, Clearwater, FL, 33760

    Description

    SoftMic Versions 4.0.4.7, 4.5.1.3. Version 4.0.4.7 Manufactured 02/03/2010. Version 4.5.1.3 Manufactured 03/18/2010. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.

    Reason

    Softmic system may delay or omit reporting of clinically significant results including organisms and drug sensitivities. Incomplete culture results may appear complete. SCC Soft Computer is issuing a Correction for SoftMic Versions 4.0.4.7-4.5.1.3 software due to this potential hazard.

    Action

    SCC Soft Computer issued Risk-to-Health notifications to clients on July 19, 2010 via proprietary communication software. Corrective actions will be via programming correction via hot fix (software modification) or such so that Global variable is not used. Clients are asked to acknowledge receipt of this task and update the task with permission to load the required correction.

    Distribution

    Worldwide Distribution: USA, including the states of CA, CT, DE, FL, IA, KY, MA, MA, MI, MN, NJ, NY, OH, PA, TX, VA, and WI, and the country of Canada.

    Quantity

    35