Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Shimadzu Trinias

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Shimadzu Triniassee related information
Date Initiated by FirmNovember 04, 2019
Create DateJuly 14, 2020
Recall Status1 Completed
Recall NumberZ-2591-2020
Recall Event ID 85416
510(K)NumberK123508 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductTrinias 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 ContactMr. 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
ActionThe 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 Commerce3 devices
DistributionUS Nationwide distribution including in the states of FL, KY, and LA. There was no government/military/foreign distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = OWB
-
-