BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated November 18, 2025

    Recall

    Recall Number
    Z-0920-2026
    Event Number
    97969
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    FEI Number
    2221819
    Product Code
    MSX
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    November 18, 2025
    Posted
    December 12, 2025
    Address
    800 Macarthur Blvd, Mahwah, NJ, 07430-2001

    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.

    Action

    Mindray notified consignees of the recall on about 11/18/2025 via certified mail. Consignees were informed that they may continue to use the Central Monitoring System. If the HP Pro Mini 400 G9 Desktop PC used by the WS experiences the audio failure or screen freezes, restart the HP Pro Mini 400 G9 Desktop PC. Consignees were instructed to ensure applicable clinical staff are aware of the issue and letter and shared with any customer if further distributed. Consignees were also asked to complete and return the Acknowledgement and Receipt form provided. Mindray will provide a patch update for the audio driver of the affected HP Pro Mini 400 G9 Desktop PCs located at each facility and is anticipated to take approximately 10-15 minutes per HP Pro Mini 400 G9 Desktop PC. A representative from Mindray's Care team will contact consignees to schedule the update.

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    906 units