BEUDAMED
    FDA Enforcement Class II Terminated

    SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0

    Recall: Z-1065-2015 · Reported February 18, 2015

    Enforcement

    Recall Number
    Z-1065-2015
    Event ID
    69837
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SCC Soft Computer
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 18, 2015
    Initiation Date
    November 26, 2014
    Classification Date
    February 9, 2015
    Termination Date
    May 16, 2016
    Address
    5400 Tech Data Drive, N/A, Clearwater, FL, 33760, United States

    Description

    SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0

    Reason

    Modifications to diagnostic text may be: 1) Saved to the database but not appear on the report sent to the physician; or 2) Documented on the report, but not saved to the database.

    Code Info

    Version 4.3.0.8 Release date: 07/31/2009 - Present; Version 4.3.0.9 Release date: 11/23/2009 - Present; Version 4.3.0.10 Release date: 09/20/2010- Present; Version 4.3.0.11 Release date: 11/11/2010- Present; Version 4.3.0.12 Release date: 02/07/2011- Present; Version 4.3.0.14 Release date: 11/14/2012- Present; Version 4.3.0.15 Release date: 09/17/2013- Present; Version 4.4.0.1 Release date: 12/13/2013 - Present;

    Distribution

    Distribution US Nationwide and CANADA.

    Quantity

    108 units