Reported Oct 24, 2018 · Terminated
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
Mindray DS USA, Inc. dba Mindray North America
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mindray DS USA, Inc. dba Mindray North America · 800 Macarthur Blvd · Mahwah, NJ · 07430-2001
Is this the product you have?
- Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
- Lot codes and dates
- This potential issue affects BeneVision DMS with software version 03.01.00 to 03.03.00
- Amount recalled
- 5
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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