Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
UPCs
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- CPSCRaychy Children's Light Sneakers Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Consumer Products with Coin Batteries; Imported by Carina and Rambo2026-06-25
- CPSCArizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by 7111495 Canada2026-06-18
- CPSCLiKee Pull String Teething Toys Recalled Due to Risk of Serious Injury or Death from Choking; Violate Mandatory Standard for Toys; Sold on Amazon by ChilanTech2026-06-11
- FDAAl Yaman Halawa Extra Pistachio 907g (31.994 oz) plastic jars, UPC 5 287000 098083, 12 retail units per case2026-06-09
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