Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Mindray BeneVision Distributed Monitoring System (DMS) Recalled by Mindray DS USA, Inc. dba Mindray North America Due to The firm has identified performance anomalies with the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mindray DS USA, Inc. dba Mindray North America directly.
Affected Products
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
Quantity: 5
Why Was This Recalled?
The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. The anomaly causes some ECG waveforms to appear as a flat line at the centralized viewing station and will manifest if more than 64 TD60 transmitters have been connected to a given central station server. Each central station supports only 32 transmitters at a time. For the issue to manifest, the BeneVision DMS needs to be configured to use flexible device assignment, have more than 64 TD60 transmitters, and the workflow must allow 64 TD60s to move around between multiple central stations in the same care area.
Where Was This Sold?
This product was distributed to 8 states: CA, CO, FL, MA, NY, PA, TX, WV
About Mindray DS USA, Inc. dba Mindray North America
Mindray DS USA, Inc. dba Mindray North America has 39 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report