FDA-Device2025-12-24Class II
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)
Mindray DS USA, Inc. dba Mindray North America
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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