Hardware configuration of the BeneVision Central Monitoring System — Class II medical device recall Z-0920-2026
Ongoing recall by Mindray DS USA, Inc. dba Mindray North America, reported 2025-12-24, distributed nationwide. When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience a
| Recall number | Z-0920-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2025-11-18 |
| Classified | 2025-12-12 |
| Reported by FDA | 2025-12-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 906 units |
| UPC / GTIN / UDI-DI | 06936415972417 |
| Model numbers | 115-050935-00, E115-050935-00 |
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)
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0920-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.