BEUDAMED
    FDA Recall Terminated

    SoftPath GUI version 4.2.3.4 2008-06-30 (Manuf Date). SoftPath GUI version 4.2.4.1 2008-09-30 (Manuf Date). SoftPath GUI version 4.3.0.3, 2008-07-23 (Manuf Date). SoftPath GUI version 4.3.0.4 2008-09-16 (Manuf Date). SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.

    Recall: Z-0102-2011 · Initiated January 26, 2009

    Recall

    Recall Number
    Z-0102-2011
    Event Number
    56272
    Firm
    SCC Soft Computer
    FEI Number
    1000307651
    Product Code
    LNX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 26, 2009
    Posted
    October 20, 2010
    Terminated
    November 3, 2010
    Address
    5400 Tech Data Drive, Clearwater, FL, 33760

    Description

    SoftPath GUI version 4.2.3.4 2008-06-30 (Manuf Date). SoftPath GUI version 4.2.4.1 2008-09-30 (Manuf Date). SoftPath GUI version 4.3.0.3, 2008-07-23 (Manuf Date). SoftPath GUI version 4.3.0.4 2008-09-16 (Manuf Date). SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.

    Reason

    For SoftPath GUI versions 4.2.3.4, 4.2.4.1, 403.0.3, and 4.3.0.4., the Previous Patient History and some QA Management reports may have missing or incorrect diagnosis text. However, the patient final report, HIS resulting and Query display are all correct. All affected clients have been provided corrected software..

    Action

    SCC Soft Computer issued a Risk-to-Health notification with Client Notification Verbiage to affected clients using SCC Soft Computer's proprietary Task Management System on January 26, 2009. SCC issued a software upgrade with corrective patch electronically to all clients. Client was asked to acknowledge receipt of the task and grant permission to load the required software. SCC will contact each client to coordinate the running of the utility and the loading and validation of the correct patch.

    Distribution

    Worldwide Distribution: Throughout USA and Canada.

    Quantity

    52