BEUDAMED
    FDA Enforcement Class II Terminated

    MEDITECH Microbiology - Calculator/data processing module, for clinical use.

    Recall: Z-1124-2014 · Reported March 12, 2014

    Enforcement

    Recall Number
    Z-1124-2014
    Event ID
    67458
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Information Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 12, 2014
    Initiation Date
    January 17, 2014
    Classification Date
    March 3, 2014
    Termination Date
    June 6, 2016
    Address
    7 Blue Hill River Rd, Canton, MA, 02021-1001, United States

    Description

    MEDITECH Microbiology - Calculator/data processing module, for clinical use.

    Reason

    Potential for patient results being removed from LAB/EMR.

    Code Info

    Model, catalogue, or product order number(s): MAGIC Releases 5.6, 5. 5.66 and Server Releases 5.6, 5.65. 6.0, 6.05, 6.06, 6.07, 6.1 and 6.13.

    Distribution

    Worldwide Distribution: US (nationwide) and to countries of: Canada, Ireland, and United Kingdom.

    Quantity

    737