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Completed

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.

FDA Recall Z-2591-2020 · Posted None

Recalling FirmShimadzu Medical Systems
Recall StatusCompleted
Product CodeOWB
Date Initiated2019-11-04
Product Quantity3 devices

Reason for Recall

The DAP meters were found to be outside of tolerance.

Firm Action

The firm issued a Field Safety Notice dated 11/5/2019 via email on 11/4/2019 describing the issue in "Digital Angiography System Trinias." The local representative was going to correct the device at the consignee locations.

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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