Recall Z-0920-2026
Mindray DS USA, Inc. dba Mindray North America · initiated November 18, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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)
Codes / lots: 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
Reason for recall
When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-0920-2026
- Initiated
- November 18, 2025
- Posted by FDA
- December 12, 2025
- Product code
- MSX – System, Network And Communication, Physiological Monitors
- Quantity
- 906 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ