Z-0920-2026 Class II Ongoing
FDA device recall Z-0920-2026 was initiated by Mindray DS USA, Inc. dba Mindray North America on November 18, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 906 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 24, 2025
- Initiation Date
- November 18, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 906 units
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)
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
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