Z-0920-2026Class II

Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed...

Name: Z-0920-2026 Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed...
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2025-11-18
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2025-11-18 / Open, Classified / root cause: software

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number... on 2025-11-18. FDA classified it as Class II and gives the reason as "When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0920-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-18
Posted: 2025-12-12
Recalling firm: Datascope Corp.
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)
Product code: MSX System, Network And Communication, Physiological Monitors
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.
Root cause tag: software
FDA 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 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.
Quantity in commerce: 906 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0920-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0920-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-12

Product code MSX

K220058Class IIBeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. / cleared 2022-06-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)