FDA-Device2025-12-24Class IIPROCESSING DEFECT
Mindray BeneVision DMS Workstation recalled for audio failure and screen freezing
OTHERNationwide distribution
Check your Mindray BeneVision DMS workstation
Mindray's BeneVision Distributed Monitoring System (DMS) workstations with specific hardware and audio driver configurations may experience audio playback failure or screen freezing during operation. This can affect the usability of the central monitoring system in clinical settings. About 906 units are affected worldwide.
- Check if your BeneVision DMS workstation uses HP Pro Mini 400 G9 desktop PC with Realtek HD Audio Driver version 6.0.9484.1
- Contact Mindray technical support to verify if your system is affected and to request guidance or a software/driver update
- Do not rely solely on audio alerts from the system until you receive confirmation that your workstation has been addressed
Hazard
When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
906 units
Manufactured in
800 Macarthur Blvd, Mahwah, NJ, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0920-2026Don't want to check this manually?
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