Recall record at a glance
| Official record | Z-0170-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America |
| Report date | Oct 24, 2018 |
| Recall initiation date | Aug 30, 2018 |
| Quantity | 5 |
| Location | Mahwah, NJ, United States |
Official product description
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
Why the product was 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.
Distribution information
Distributed to accounts in CA, CO, FL, MA, NY, PA, PR, TX, and WV.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.