FDA Devices recall · Reported October 24, 2018
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
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…
Mindray Ds USA, Inc. dba Mindray North America recalled Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00 - a moderate-severity action.
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00 was recalled by Mindray Ds USA, Inc. dba Mindray North America in October 24, 2018. Reason: The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmi…. Check the official notice for the remedy. Verify recall #Z-0170-2019 with the FDA Devices before acting.
The recall
Mindray Ds USA, Inc. dba Mindray North America issued this moderate-severity FDA Devices recall-The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmi….
- Moderate
- severity level
- 5 units
- affected scope
- Class II
- classification
- October 24, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0170-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0170-2019 |
| Date reported | October 24, 2018 |
| Date initiated | August 30, 2018 |
| Recalling firm | Mindray Ds USA, Inc. dba Mindray North America |
| Firm location | Mahwah, NJ |
| Affected scope | 5 |
| Distribution | Distributed to accounts in CA, CO, FL, MA, NY, PA, PR, TX, and WV. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0170-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026