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U.S. Department of Health and Human Services

Class 2 Device Recall Shimadzu Trinias

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  Class 2 Device Recall Shimadzu Trinias see related information
Date Initiated by Firm November 04, 2019
Create Date July 14, 2020
Recall Status1 Completed
Recall Number Z-2591-2020
Recall Event ID 85416
510(K)Number K123508  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
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.
Code Information Serial numbers LR051A58B027, LR051A58B028, and LR051A58B029.  
Recalling Firm/
Manufacturer
Shimadzu Medical Systems
20101 S Vermont Ave
Torrance CA 90502-1328
For Additional Information Contact Mr. John Goossens
310-217-8855 Ext. 174
Manufacturer Reason
for Recall
The DAP meters were found to be outside of tolerance.
FDA Determined
Cause 2
Device Design
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.
Quantity in Commerce 3 devices
Distribution US Nationwide distribution including in the states of FL, KY, and LA. There was no government/military/foreign distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = Shimadzu Corporation
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