BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2569-2025 · Initiated February 5, 2025

    Recall

    Recall Number
    Z-2569-2025
    Event Number
    97455
    Firm
    Medical Information Technology, Inc.
    FEI Number
    3009404844
    Product Code
    JQP
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    February 5, 2025
    Posted
    September 16, 2025
    Address
    7 Blue Hill River Rd, Canton, MA, 02021-1001

    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.

    Action

    Consignees were notified via Salesforce email of this recall issue and provided instructions on workarounds

    Distribution

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

    Quantity

    148 units