Z-0170-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 24, 2018
- Initiation Date
- August 30, 2018
- Termination Date
- December 20, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
Product Description
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
Reason for Recall
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.
Distribution Pattern
Distributed to accounts in CA, CO, FL, MA, NY, PA, PR, TX, and WV.
Code Information
This potential issue affects BeneVision DMS with software version 03.01.00 to 03.03.00