Mindray DS USA, Inc. dba Mindray North America recalls Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00

Recall date

August 30, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0170-2019

FDA classification

Class II

Brand / firm

Mindray DS USA, Inc. dba Mindray North America

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00