Medical device recalls Moderate risk

Mindray DS USA, Inc. dba Mindray North America recalls Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring…

Recall date
November 18, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0920-2026
FDA classification
Class II
Brand / firm
Mindray DS USA, Inc. dba Mindray North America
Sold / distributed
Worldwide distribution - US Nationwide and the country of Canada.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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)

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