Recall Z-0920-2026 ยท MSX System, Network And Communication, Physiological Monitors
Mindray DS USA, Inc. dba Mindray North America
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)
| Date | Dec 12, 2025 (initiated Nov 18, 2025) |
| Status | Open, Classified |
| Reason | When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing. |
| Root cause | Software design |
| Action | 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 fo |
| Quantity | 906 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220058 | BeneVision Central Monitoring System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Jun 1, 2022 |