Lower riskMedical device recall · FDA · Published August 30, 2018
Mindray BeneVision DMS: Flat ECG Waveforms When Too Many Transmitters Connected
Mindray recalls BeneVision DMS software versions 03.01.00 to 03.03.00 due to ECG waveforms showing flat lines when more than 64 TD60 transmitters are connected to a central station.
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.
Take action
Contact the company
📍Recalling firmMindray DS USA, Inc. dba Mindray North America800 Macarthur Blvd · Mahwah, NJ 07430-2001
“Mindray BeneVision DMS: Flat ECG Waveforms When Too Many Transmitters Connected.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69937-mindray-benevision-dms-flat-ecg-waveforms-when-too-many-transmitters. Based on FDA recall #Z-0170-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0170-2019%22&limit=1).
Mindray DS USA, Inc. dba Mindray North America recalled the BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00, due to performance anomalies causing ECG waveforms to appear as a flat line. The Food and Drug Administration announced this Class II recall on August 30, 2018.
How to tell if you have it
Brand: Mindray
Product: BeneVision Distributed Monitoring System (DMS)
Part No.: 115-034413-00
Software version: 03.01.00 to 03.03.00
The hazard
The firm identified performance anomalies when more than 64 TD60 telemetry transmitters are connected to a central station, causing some ECG waveforms to appear as a flat line at the centralized viewing station. Each central station supports only 32 transmitters at a time.
Context
GovInfoNow's records show Mindray DS USA, Inc. dba Mindray North America has 13 other recalls on record since July 14, 2017. Other recent recalls of similar products include Mindray BeneVision Distributed Monitoring: Audio Failure Risk (November 18, 2025), Mindray Isoflurane V90 Vaporizer Recall (October 20, 2025), and Mindray BeneVision N1 Patient Monitor Recall (August 15, 2025). Other recent recalls of similar products include Mindray ePM Patient Monitors: Insufficient Alarm Manual Descriptions (August 31, 2026).
How to tell if you have this one
Check if your BeneVision DMS has software version 03.01.00 to 03.03.00. The issue affects systems where more than 64 TD60 transmitters are connected to a central station server.
Brand
Mindray
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your BeneVision DMS software version is 03.01.00 to 03.03.00.
Where it went and when
Where it was distributed
Distributed in 8 states and Puerto Rico.
Listed by the agency
Not listed
FDA distribution: “Distributed to accounts in CA, CO, FL, MA, NY, PA, PR, TX, and WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Florida, Massachusetts, New York, Pennsylvania, Puerto Rico, Texas, West Virginia.
Recall timeline
FDA terminated this recall 4 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0170-2019 (August 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0170-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.