BeneVision Central Monitoring System recallZ-0920-2026 · Mindray DS USA, Inc. dba Mindray North America · initiated Nov 18, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mindray DS USA, Inc. dba Mindray North America or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Software design
What the company is doing
Mindray notified consignees of the recall on about 11/18/2025 via certified mail. Consignees were informed that they may continue to use the Central Monitoring System. If the HP Pro Mini 400 G9 Desktop PC used by the WS experiences the audio failure or screen freezes, restart the HP Pro Mini 400 G9 Desktop PC. Consignees were instructed to ensure applicable clinical staff are aware of the issue and letter and shared with any customer if further distributed. Consignees were also asked to complete and return the Acknowledgement and Receipt form provided. Mindray will provide a patch update for the audio driver of the affected HP Pro Mini 400 G9 Desktop PCs located at each facility and is anticipated to take approximately 10-15 minutes per HP Pro Mini 400 G9 Desktop PC. A representative from Mindray's Care team will contact consignees to schedule the update.
Recall details
- Recall number
- Z-0920-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 18, 2025
- Posted by the FDA
- Dec 12, 2025
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Quantity
- 906 units
- Product code
- MSX
- FDA submissions
- K220058
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
Product description
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)
Code information (models, lots, serial numbers)
Audio Driver Version: 6.0.9484.1. UDI-DI: 06936415972417. HP Pro Mini 400 G9 Desktop PC. Realtek HD Audio Driver Released by HP. 1. WS host package (mini PC). Part Number 115-050935-00. Quantity 902 2. Exch, Benevision Mini PC Workstation. Part Number E115-050935-00. Quantity 4
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · System, Network And Communication, Physiological Monitors1 recall2 deaths5 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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