FDA Device recall Z-0170-2019
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
- FDA Device
- Class II
- terminated
- Published 2018-10-24
On 2018-10-24 the FDA classified a Class II recall of Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00 by Mindray Ds Usa, citing 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 som….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0170-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-30 |
| Published | 2018-10-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mindray Ds Usa |
| Distribution | CA, CO, FL, MA, NY, PA, PR, TX, WV |
Product
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
Reason
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.
Identifiers
| code_info | This potential issue affects BeneVision DMS with software version 03.01.00 to 03.03.00 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0170-2019%22
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