Shimadzu Medical Systems recalls Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It i…

Recall date

November 4, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2591-2020

FDA classification

Class II

Brand / firm

Shimadzu Medical Systems

Sold / distributed

US Nationwide distribution including in the states of FL, KY, and LA. There was no government/military/foreign distribution.

Why it was recalled

The DAP meters were found to be outside of tolerance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.