Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring
FDA device recall Z-0920-2026 · posted 2025-12-12 · Open, Classified
Recall details
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- 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.
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- MSX
- Quantity affected
- 906 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Date initiated
- 2025-11-18
- Date posted
- 2025-12-12
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BeneVision Central Monitoring System (K220058) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-06-01 |