BEUDAMED
    FDA Recall Terminated

    SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for receiving accessing specimen reports, billing and management reports for surgical, GYN, NON-GYN and Autopsy cases.

    Recall: Z-2329-2008 · Initiated February 23, 2006

    Recall

    Recall Number
    Z-2329-2008
    Event Number
    35369
    Firm
    SCC Soft Computer
    FEI Number
    1000307651
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 23, 2006
    Posted
    September 22, 2008
    Terminated
    November 20, 2008
    Address
    5400 Tech Data Drive, Clearwater, FL, 33760

    Description

    SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for receiving accessing specimen reports, billing and management reports for surgical, GYN, NON-GYN and Autopsy cases.

    Reason

    Loss of text misrepresented individual tissue diagnosis on the final diagnosis print out from the HIS system software. The specimen heading "J" was removed and the diagnosis appeared under the specimen heading "I" as a result the specimen with the heading "I" had two diagnosis.

    Action

    Software corrections were sent as of 10/30/2003 for clients to upgrade to, the correction software patch is in versions 3.17.5.16, 3.17.6.10, 3.17.7.3 and 4.1.1.0. The firm did not inform the non-affected consignees of the failure because the firm concluded that the associated risk was low.

    Distribution

    Worldwide Distribution including USA and the country of Canada.

    Quantity

    335