Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Trinias DAP Meter Recalled by Shimadzu Medical Systems Due to The DAP meters were found to be outside...

Date: November 4, 2019
Company: Shimadzu Medical Systems
Status: Completed
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Shimadzu Medical Systems directly.

Affected Products

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.

Quantity: 3 devices

Why Was This Recalled?

The DAP meters were found to be outside of tolerance.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Shimadzu Medical Systems

Shimadzu Medical Systems has 25 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report