BEUDAMED
    FDA Enforcement Class II Terminated

    MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information.

    Recall: Z-1365-2013 · Reported May 29, 2013

    Enforcement

    Recall Number
    Z-1365-2013
    Event ID
    65158
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Information Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 29, 2013
    Initiation Date
    May 7, 2013
    Classification Date
    May 22, 2013
    Termination Date
    October 1, 2014
    Address
    Meditech Circle, N/A, Westwood, MA, 02090, United States

    Description

    MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information.

    Reason

    Incorrect transmission of laboratory results.

    Code Info

    Magic Releases 5.41, 5.52. 5.53, 5.62, 5.63, 5.64 and Client Server Releases 5.64, 5.65, 6.05, 6.06, 6.07

    Distribution

    Worldwide Distribution - USA, including Puerto Rico and the country of Canada.

    Quantity

    56 devices