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Recall

Class II — Mindray DS USA, Inc. dba Mindray North America

Recalling firmMindray DS USA, Inc.
Registered facilityMINDRAY DS USA, Inc. (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonWhen the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.
ProductHardware 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)
Quantity906 units
DistributionWorldwide distribution - US Nationwide and the country of Canada.
Initiated2025-11-18
Classified2025-12-12
Recall numberZ-0920-2026
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Mindray DS USA, Inc. dba Mindray North America (Z-0920-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97969/

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