BEUDAMED
    FDA Recall Terminated

    SoftPath ASCII Software, used in pathology labs to track and report specimens and diagnostic results. Releases 1.2, 2.1, and 2.3

    Recall: Z-1252-06 · Initiated January 9, 2001

    Recall

    Recall Number
    Z-1252-06
    Event Number
    35375
    Firm
    SCC Soft Computer
    FEI Number
    1000307651
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 9, 2001
    Posted
    July 26, 2006
    Terminated
    July 19, 2010
    Address
    34350 US Highway 19 N, Palm Harbor, FL, 34684-2149

    Description

    SoftPath ASCII Software, used in pathology labs to track and report specimens and diagnostic results. Releases 1.2, 2.1, and 2.3

    Reason

    The client had made a decision to use the SoftPath Module in a nonstandard manner. Under specific circumstances, incorrect text may appear on a patient report.

    Action

    The firm issued a software correction letter to its consignees 1/9/2001, advising them of the problem and supplied them with a software patch ICC number 3618 also referred to as release 3.0. The firm advised its clients that the installation of this software to their system was mandatory.

    Distribution

    Nationwide and Canada.

    Quantity

    171