Recall Z-2591-2020— Shimadzu Medical Systems

Name: FDA recall Z-2591-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-04

Class II · Completed

Class II FDA medical device recall by Shimadzu Medical Systems, initiated 2019-11-04. It names one FDA 510(k) clearance: K123508. 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.. Reason: The DAP meters were found to be outside of tolerance..

Recalling firm: Shimadzu Medical Systems
Classification: Class II
Status: Completed
Initiated: 2019-11-04
Firm location: Torrance, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K123508 — TRINIASShimadzu Corporation·cleared 2014-02-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

The DAP meters were found to be outside of tolerance.

Data sourced from openFDA. This site is unofficial and independent of the FDA.