FDANovember 4, 2019device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The DAP meters were found to be outside of tolerance.

What to do

FDA enforcement status: Completed

Brands named

shimadzu medical systemsshimadzushimadzu medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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