Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision ...
FDA Recall #Z-0920-2026 — Class II — November 18, 2025
Product 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 for Recall
When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.
Recalling Firm
Mindray DS USA, Inc. dba Mindray North America — Mahwah, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
906 units
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated