BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.

    Recall: Z-2569-2025 · Reported September 24, 2025

    Enforcement

    Recall Number
    Z-2569-2025
    Event ID
    97455
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medical Information Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 24, 2025
    Initiation Date
    February 5, 2025
    Classification Date
    September 16, 2025
    Address
    7 Blue Hill River Rd, N/A, Canton, MA, 02021-1001, United States

    Description

    MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.

    Reason

    Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.

    Code Info

    Software Release: 2.1, 2.2 (using the Web Presentation Layer); UDI: 00863529000155.

    Distribution

    Worldwide distribution - US Nationwide and the countries of British Virgin Islands, Canada, Ireland & United Kingdom.

    Quantity

    148 units