BEUDAMED
    FDA Recall Terminated

    MEDITECH Anatomical Pathology Software Client Releases- Client Service Releases 5.6, 5.63, 5.64, 5.65, 6.0, 6.04, 6.05, 6.06, 6.1, 6.12 and 6.13 Product Usage: Meditech Anatomical Pathology Software records, stores, codes, searches and provides reports for pathology cases. It enables pathology staff and other personnel to access related findings in real time.

    Recall: Z-1465-2012 · Initiated March 30, 2012

    Recall

    Recall Number
    Z-1465-2012
    Event Number
    61510
    Firm
    Medical Information Technology, Inc. Meditech Circle
    FEI Number
    1000120736
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 30, 2012
    Posted
    April 26, 2012
    Terminated
    August 13, 2014
    Address
    Westwood, MA, 02090

    Description

    MEDITECH Anatomical Pathology Software Client Releases- Client Service Releases 5.6, 5.63, 5.64, 5.65, 6.0, 6.04, 6.05, 6.06, 6.1, 6.12 and 6.13 Product Usage: Meditech Anatomical Pathology Software records, stores, codes, searches and provides reports for pathology cases. It enables pathology staff and other personnel to access related findings in real time.

    Reason

    Meditech Anatomical Pathology software is being recalled because data on a pathology specimen may be inadvertently deleted.

    Action

    MEDITECH sent a notification beginning on January 19, 2012 to customers who are LIVE with MEDITECH Client Server Anatomical Pathology 5.6 and higher. This notification was made via e-mailed task updates that informed customers of the software issues and the code corrections that are available.

    Distribution

    Worldwide Distribution - USA Nationwide and the countries of Bahamas, Canada and United Kingdom.

    Quantity

    280