BEUDAMED
    FDA Recall Open, Classified

    Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring

    Recall: Z-0320-2025 · Initiated October 11, 2024

    Recall

    Recall Number
    Z-0320-2025
    Event Number
    95559
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    MLO
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    October 11, 2024
    Posted
    November 7, 2024
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring

    Reason

    There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.

    Action

    Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 10/11/2024 via USPS First Class Mail. The notice explained the issue, potential hazard to the patient, and provided instructions for the to the system IT administrator to correct the issue which is already available in the current version of software.

    Distribution

    Worldwide distribution.

    Quantity

    599 units