Mindray recalls BeneVision DMS software versions 03.01.00 to 03.03.00 due to ECG waveforms showing flat lines when more than 64 TD60 transmitters are connected to a central station.
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.
Mindray is recalling BeneVision Distributed Monitoring System software versions 03.01.00 to 03.03.00. The issue causes ECG waveforms to appear flat when more than 64 TD60 transmitters are connected to a central station, which could lead to missed medical readings.
The device shows flat ECG waveforms when more than 64 TD60 telemetry transmitters are connected to a central station. This happens because each central station can only handle 32 transmitters at a time. The problem occurs only if the system is configured for flexible device assignment and allows 64 transmitters to move between stations.
Healthcare providers using Mindray BeneVision DMS with software versions 03.01.00 to 03.03.00 are most at risk. The issue affects systems where more than 64 TD60 transmitters are connected to a central station.
Check if your BeneVision DMS has software version 03.01.00 to 03.03.00. The issue affects systems where more than 64 TD60 transmitters are connected to a central station server.
Verify your BeneVision DMS software version is 03.01.00 to 03.03.00.
The recall is due to ECG waveforms appearing flat when more than 64 TD60 transmitters are connected to a central station, which can cause missed medical readings.
Check if your BeneVision DMS has software version 03.01.00 to 03.03.00 and if more than 64 TD60 transmitters are connected to a central station.
No action is needed if your device has fewer than 64 TD60 transmitters connected or uses a different software version.
We’ve drafted a message you can send Mindray to request your refund or repair — edit it as you like.
Subject: Recall Z-0170-2019 — Mindray Mindray Hello, I own a Mindray that is covered by recall Z-0170-2019 from Mindray. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
