Mindray BeneVision recall
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
Why was Mindray BeneVision 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
This potential issue affects BeneVision DMS with software version 03.01.00 to 03.03.00
- Product
- Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Quantity
- 5
- Distribution
- Distributed to accounts in CA, CO, FL, MA, NY, PA, PR, TX, and WV.
- Recall date
- October 24, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)