Class 2 Device Recall TRINIAS

• Date Initiated by Firm: June 15, 2018
• Date Posted: October 19, 2018
• Recall Status: Terminated on April 28, 2021
• Recall Number: Z-0197-2019
• Recall Event ID: 81080
• 510(K)Number: K123508
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
• Code Information: Model Trinias UDI (01)04540217049080(11)170727(21)41E58C977001 Serial Number 41E58C977001
• Recalling Firm/ Manufacturer: Shimadzu Medical Systems Usa Com; 20101 S Vermont Ave; Torrance CA 90502-1328
• Manufacturer Reason for Recall: Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or healthcare personnel.
• FDA Determined Cause: Software design
• Action: On June 15, 2018, the firm sent an URGENT Voluntary Medical Device Recall Notice to its customer via certified mail informing the customer that the Trinias C-arm could unexpectedly move while being moved to the park position and/or when performing specific operations. An investigation has shown that a software defect in the MH300, which is a floormount C-arm tube support of the Trinias biplane system, caused this event under specific conditions described as below. Neither the Trinias single plane system nor the Trinias dual plane system have the software defect. If the incident were to recur, there is a possibility the C-arm will come into contact with a patient or healthcare personnel. The specific conditions are as follows: (1) The table top is positioned at head side so that the C-arm safety interlock is active. (2) If operator performs a parking operation and presses a direct memory switch at the same time, the the software runs abnormally, and the C-arm does not movebecause the safety interlock is active (1). (3) If the operator then moves the table top to foot side, the C-arm safety interlock is cancelled. (4) While the C-arm safety interlock is cancelled due to the actions performed in (3), the C-arm starts moving without the operators control. Therefore, the firm will implement a voluntary recall/field corrective action to revise the software, thereby fixing the problem. This Field Safety Notice is intended to inform the customer about: - the description of the issue - the actions planned by Shimadzu to correct the issue - the actions that should be taken by the customer How to identify the affected products: The Shimadzu Digital Angiographic System Trinias; Serial Number 41E58C977001 Please contact the local Shimadzu representative or contact Shimadzu National Technical Support. Corrective action plan by Shimadzu: After the software defect has been corrected and the correction safety and efficacy have been verified through our verifi
• Quantity in Commerce: 1
• Distribution: Domestic: LA
• 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