FDA recall Z-0170-2019

Mindray DS USA, Inc. dba Mindray North America · Class II · device

Product

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

Distributed to accounts in CA, CO, FL, MA, NY, PA, PR, TX, and WV.

Key facts

Status: Terminated
Initiation date: 2018-08-30
Report date: 2018-10-24
Termination date: 2018-12-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0170-2019