Central monitoring workstations recalled over audio failure and screen freezing
Mindray is recalling 906 BeneVision Distributed Monitoring System units because a specific workstation hardware configuration may experience audio playback failure or screen freezing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: audio failure or screen freezing on a central patient monitoring workstation can interrupt how staff receive information, and no injuries are reported.
Plain-English summary
The hardware configuration of the BeneVision Central Monitoring System, marketed as the BeneVision Distributed Monitoring System, models 115-050935-00 and E115-050935-00, is being recalled by Mindray North America.
When the workstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.
The record lists 906 units, carrying UDI-DI 06936415972417, with audio driver version 6.0.9484.1 on the HP Pro Mini 400 G9 desktop PC. Distribution was worldwide, including nationwide in the United States and to Canada. The FDA has classified the action as Class II.
A monitoring workstation that loses audio or freezes may not present information to staff as expected. The enforcement record reports no injuries. Facilities should follow Mindray's instructions.
The recalled product
- 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…
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Category
- Medical Device — Patient monitor
- Affected units
- 906
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Benevision Mini PC Workstation. Part Number E115-050935-00. Quantity 4
Distribution
Distributed nationwide across the United States.
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