Mindray DS USA, Inc. dba Mindray North America: Medical Device Recall in 2018 - (Recall #: Z-0170-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 30, 2018

Date Posted: October 24, 2018

Recall Number: Z-0170-2019

Event ID: 81084

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.

Status: Terminated

Product Quantity: 5

Code Information:

This potential issue affects BeneVision DMS with software version 03.01.00 to 03.03.00

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated