BEUDAMED
    FDA Enforcement Class II Ongoing

    Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1 HP Pro Mini 400 G9 Desktop PC with Realtek HD Audio Driver Officially Released by HP (audio driver version 6.0.9484.1)

    Recall: Z-0920-2026 · Reported December 24, 2025

    Enforcement

    Recall Number
    Z-0920-2026
    Event ID
    97969
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 24, 2025
    Initiation Date
    November 18, 2025
    Classification Date
    December 12, 2025
    Address
    800 Macarthur Blvd, Mahwah, NJ, 07430-2001, United States

    Description

    Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1 HP Pro Mini 400 G9 Desktop PC with Realtek HD Audio Driver Officially Released by HP (audio driver version 6.0.9484.1)

    Reason

    When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.

    Code Info

    Audio Driver Version: 6.0.9484.1. UDI-DI: 06936415972417. HP Pro Mini 400 G9 Desktop PC. Realtek HD Audio Driver Released by HP. 1. WS host package (mini PC). Part Number 115-050935-00. Quantity 902 2. Exch, Benevision Mini PC Workstation. Part Number E115-050935-00. Quantity 4

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    906 units