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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Mindray BeneVision DMS Recalled for Screen Freezing and Audio Failure

Agency Publication Date: December 12, 2025
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Summary

Mindray DS USA is recalling 906 units of the BeneVision Distributed Monitoring System (DMS) workstations. These specific configurations, which use the HP Pro Mini 400 G9 Desktop PC and a particular Realtek audio driver, may experience screen freezing or audio playback failure. This defect can prevent healthcare providers from seeing or hearing critical patient monitoring data or alarms, potentially delaying emergency medical response. Mindray is initiating corrections for affected units distributed in the United States and Canada.

Risk

If the workstation screen freezes or the audio fails, the system cannot alert medical staff to changes in a patient's vital signs or emergency conditions. This creates a risk of delayed treatment for patients in clinical settings who rely on these systems for continuous monitoring.

What You Should Do

  1. This recall affects the BeneVision Central Monitoring System (CMS), marketed as the BeneVision Distributed Monitoring System (DMS), specifically models 115-050935-00 and E115-050935-00 using Realtek HD Audio Driver version 6.0.9484.1.
  2. Check your workstation host package (mini PC) for part numbers 115-050935-00 or E115-050935-00 and verify if the software is using Audio Driver version 6.0.9484.1.
  3. Stop using the recalled device for active patient monitoring if it matches the affected hardware and software configuration.
  4. Contact Mindray North America or your authorized distributor to arrange for a hardware or software correction, replacement, or return of the affected workstation.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have further questions regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Firm-initiated correction and replacement.

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: BeneVision Distributed Monitoring System (DMS) Workstation
Variants: HP Pro Mini 400 G9 Desktop PC, Realtek HD Audio Driver version 6.0.9484.1
Model / REF:
115-050935-00
E115-050935-00
UDI:
06936415972417

Includes 902 units of Part Number 115-050935-00 and 4 units of Part Number E115-050935-00.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97969
Status: Active
Manufacturer: Mindray DS USA, Inc. dba Mindray North America
Sold By: Mindray North America; Authorized Medical Device Distributors
Manufactured In: United States
Units Affected: 906 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.