Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97969

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 18, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Mindray DS USA, Inc. dba Mindray North America

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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)

Z-0920-2026
Recall number
Z-0920-2026
Initiated
November 18, 2025
Classification
Class II
Status
Ongoing
Quantity
906 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

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

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.