Recall Z-0920-2026— Mindray DS USA, Inc. dba Mindray North America
Class II · Ongoing
Class II FDA medical device recall by Mindray DS USA, Inc. dba Mindray North America, initiated 2025-11-18. It names one FDA 510(k) clearance: K220058. 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: When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing..
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-11-18
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.