CLASS II Device recall · Reported 24 Oct 2018 · FDA Enforcement Report
Mindray BeneVision Distributed Monitoring System (DMS) recalled
Mindray DS USA is recalling Mindray BeneVision Distributed Monitoring System (DMS), distributed in 9 states. The recall was initiated on 30 Aug 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0170-2019
- FDA event ID
- 81084
- Recalling firm
- Mindray DS USA, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Aug 2018
- FDA classified
- 17 Oct 2018
- Reported
- 24 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 30 Aug 2018 | Recall initiated by company | |
| 17 Oct 2018 | Classified by FDA | +48 days |
| 24 Oct 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
Where it was distributed
Distributed to accounts in CA, CO, FL, MA, NY, PA, PR, TX, and WV.
CaliforniaColoradoFloridaMassachusettsNew YorkPennsylvaniaPuerto RicoTexasWest Virginia
Questions about this recall
Is Mindray BeneVision Distributed Monitoring System (DMS) recalled?
Yes. Mindray DS USA recalled Mindray BeneVision Distributed Monitoring System (DMS) on 30 Aug 2018. The recall is Class II and its status is Terminated. Recall number Z-0170-2019.
Why was it 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 lots are affected?
This potential issue affects BeneVision DMS with software version 03.01.00 to 03.03.00
Where was it sold?
Distributed to accounts in CA, CO, FL, MA, NY, PA, PR, TX, and WV.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mindray DS USA
All 39| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hardware configuration of the BeneVision Central Monitoring recalled | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS II | The Anesthesia System is a device used to administer to recalled | Mindray DS USA | Packaging Defects | Nationwide |
| Device | CLASS II | The Anesthesia System is a device used to administer to recalled | Mindray DS USA | Packaging Defects | Nationwide |
| Device | CLASS II | BeneVision N1 Patient Monitor (N1) recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS II | Sevoflurane E_Vap.(Quik-Fil):used recalled by Mindray DS USA | Mindray DS USA | Packaging Defects | Nationwide |
Other Patient Monitors recalls
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|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |