Mindray BeneVision Distributed Monitoring System Recalled for ECG Display Anomalies
Mindray is recalling five BeneVision Distributed Monitoring Systems due to a software issue that can cause ECG waveforms to display as a flat line when more than 64 telemetry transmitters are connected.
What this means for you
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: The recall involves a medical device where a display error could lead to misinterpretation of patient data, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Mindray DS USA, Inc. dba Mindray North America is recalling five units of the Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00. The recall affects devices running software versions 03.01.00 through 03.03.00.
The recall was initiated because the firm identified performance anomalies that occur when more than 64 TD60 telemetry transmitters are connected to a central station. Under specific configuration conditions, this issue causes some ECG waveforms to appear as a flat line at the centralized viewing station. The anomaly manifests only if the system is configured to use flexible device assignment, has more than 64 TD60 transmitters, and allows those transmitters to move between multiple central stations in the same care area.
The affected units were distributed to accounts in California, Colorado, Florida, Massachusetts, New York, Pennsylvania, Puerto Rico, Texas, and West Virginia. Healthcare facilities should contact Mindray for further instructions on how to resolve the software issue.
The recalled product
- Product
- Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Affected units
- 5
Distribution
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