BEUDAMED
    FDA Recall 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 · Initiated November 26, 2014

    Recall

    Recall Number
    Z-1065-2015
    Event Number
    69837
    Firm
    SCC Soft Computer
    FEI Number
    1000307651
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 26, 2014
    Posted
    February 9, 2015
    Terminated
    May 16, 2016
    Address
    5400 Tech Data Drive, Clearwater, FL, 33760

    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.

    Action

    On 11/26/2014 SCC Soft Computer sent a Correction Communication to their consignees: Corrective Action: Versions 4.3.0.8 through 4.4.0.2 will have a mandatory hotfix created. Due to the amount of versions affected, the range of availability dates will be 11/24/2014 through 12/30/2014. Utility: A utility will be made available to be run on your Live system that will identify cases in which there is a disparity between the diagnosis text in the document and the database. The utility output will be provided for client review and validation.

    Distribution

    Distribution US Nationwide and CANADA.

    Quantity

    108 units