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Shimadzu Medical Systems recalls Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is
Recalled July 22, 2020 · FDA recall Z-2591-2020 · Shimadzu Medical Systems
Hazard
The DAP meters were found to be outside of tolerance. · FDA Class II
Units
3 devices
Sold at
US Nationwide distribution including in the states of FL, KY, and LA. There was no government/military/foreign distribution.
Description
The DAP meters were found to be outside of tolerance.
Product
Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology.
Manufacturer(s)
Shimadzu Medical Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →