Severity
Moderate
ModerateClass IITerminated
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-0170-2019) was formally reported on October 24, 2018, with the manufacturer initiating the action on August 30, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Mindray Ds USA, Inc. dba Mindray North America is listed as the recalling firm, operating out of Mahwah, NJ. Federal records list the affected scope as 5.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Distributed to accounts in CA, CO, FL, MA, NY, PA, PR, TX, and WV.. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
5
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00. Recalled by Mindray Ds USA, Inc. dba Mindray North America. Units affected: 5.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 24, 2018. Severity: Moderate. Recall number: Z-0170-2019.
Where was the recalled product distributed? ▼
Distribution: Distributed to accounts in CA, CO, FL, MA, NY, PA, PR, TX, and WV..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0170-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 24, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.