BEUDAMED
    FDA Recall Terminated

    SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.

    Recall: Z-1038-2015 · Initiated May 20, 2014

    Recall

    Recall Number
    Z-1038-2015
    Event Number
    70021
    Firm
    SCC Soft Computer
    FEI Number
    1000307651
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 20, 2014
    Posted
    February 2, 2015
    Terminated
    May 16, 2016
    Address
    5400 Tech Data Drive, Clearwater, FL, 33760

    Description

    SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.

    Reason

    The interface fails to send abnormal flags for Reference Lab test results.

    Action

    The firm sent out 2 CORRECTION COMMUNICATIONS informing consignees of functionality in release of 4.0.7 HIS Add-on interfaces which SCC has designated to be a potential patient Risk-to-Health issue. Further the corrective action indicated HIS releases 4.0.7.2 and higher will be corrected. Hot Fixes have been developed for HIS Add-on patches 4.0.7.0 and 4.0.7.1. Lastly the communication requests that the user "please acknowledge receipt of this task and grant permission to load the mandatory hot fix(es). Thank you."

    Distribution

    Distributed US (nationwide) in the states of OH, GA, NJ, WI, FL, NH, IL, NY, IN, CA, AL, VA, MO, MI, KY, MA, PA, CO, ME, TN, WA, MN, SD, LA, NC, and NV and the country of Canada.

    Quantity

    48