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U.S. Department of Health and Human Services

Class 2 Device Recall TRINIAS Interventional fluoroscopic xray system

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  Class 2 Device Recall TRINIAS Interventional fluoroscopic xray system see related information
Date Initiated by Firm January 14, 2019
Create Date February 21, 2019
Recall Status1 Terminated 3 on April 30, 2021
Recall Number Z-0864-2019
Recall Event ID 82002
510(K)Number K123508  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
Code Information Serial Numbers: 41B247746001, 41B24774C001, 41E58C757001, 41E58C765001, 41E58C766001, 41E58C769001, 41E58C76B001, 41E58C773001, 41E58C775001, 41E58C776001, 41E58C777001,  41E58C977001, 41EFCD77C001  
Recalling Firm/
Manufacturer		 Shimadzu Medical Systems Usa Com
20101 S Vermont Ave
Torrance CA 90502-1328
Manufacturer Reason
for Recall		 Two issues: Event 1: Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure. Event 2: In rare cases a synchronization error may occur in the data transmission circuit in the device due to external noise. The visibility of the displayed image may be corrupted (images become bit-shifted abnormal images). If this event occurs, it may become difficult to see the object, which may hinder the examination and treatment.
FDA Determined
Cause 2		 Software design
Action The dealers by email on 01/14/2019 and the end users by mail on 01/15/2019. The letters to the end users explain the problem and a workaround. A service representative will contact the end user to schedule a software update.
Quantity in Commerce 13 units
Distribution FL, MT, CT, OH, IL, TX, MS, LA, SC
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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = Shimadzu Corporation
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