Mindray BeneVision Distributed Monitoring System — Class II medical device recall Z-0170-2019
Terminated recall by Mindray DS USA, Inc. dba Mindray North America, reported 2018-10-24, distributed in CA, CO, FL, MA, NY, PA, PR, TX…. The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmit
| Recall number | Z-0170-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2018-08-30 |
| Classified | 2018-10-17 |
| Reported by FDA | 2018-10-24 |
| Terminated | 2018-12-20 |
| Distributed | CA, CO, FL, MA, NY, PA, PR, TX, WV |
| Quantity | 5 |
| Model numbers | 115-034413-00 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0170-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.