Class 2 Device Recall Shimadzu Trinias

• Date Initiated by Firm: December 16, 2021
• Create Date: February 28, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0655-2022
• Recall Event ID: 89253
• 510(K)Number: K123508
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
• Code Information: Generator Model: D150GC-40 Serial Number Range - 3M99D44446001to LM99D44B8001 Serial Number/SMS ID: 41E58C765001/SMS20160146 41EFCD78B001/SMS20190007 41EFD3B9A001/SMS20200009 41F005CB8001/SMS20210266 41E58C766001/SMS20160150 41B247746001/SMS20140089 41E58C757001/SMSHP150024 41E58C769001/SMS20160151 41E58C777001/SMS20170121 41EFCD77C001/SMS20180143 41F005B8C001/SMS20190052 41EFCD79A001/SMS20190366 41EFCD79C001/SMS20200285 41EFC73A5001/SMS20200263 41EFCD7A6001/SMS20200267 41EFC73A9001/SMS20200443 41E5E23AA001/SMS20200369 41E58C773001/SMSHP170001 41E58C977001/SMS20170424 41EFFF79A001/SMS20190376 41EFFF79C001/SMS20200031 41EFD3B9C001/SMS20200066 41E58C76B001/SMS20170288 41E58C775001/SMS20170134 41E58C776001/SMS20170135 41F005B91001/SMS20190019 41B24774C001/SMSMA140084 41EFCD7AC001/#N/A
• Recalling Firm/ Manufacturer: Shimadzu Medical Systems; 20101 S Vermont Ave; Torrance CA 90502-1328
• For Additional Information Contact: Johnny Goossens; 310-217-8855 Ext. 130
• Manufacturer Reason for Recall: Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.
• FDA Determined Cause: Process change control
• Action: On 12/13/2021, the firm sent an "Urgent: Voluntary Medical Device Recall Notice" to distributors who hand-delivered to customers informing them that there is a potential issue with the adjustment procedure for the calibration of the x-ray generators for the Digital Angiography Systems and occurs during the calibration of the fluoroscopic mode which could cause x-ray radiation dose rate to exceed regulation and/or standards. Customers are instructed to: -Check their systems for the affected generators. -Contact their distributor to schedule a system update and calibration. -If customers feel there are any issues with their system, they are asked to discontinue use of the system and contact their local service providers. The Recalling Firm has identified that affected units and have informed the authorized service representatives. The authorized servicers should be contacting customers to schedule time to implement the corrective action (update and calibrate). Customers can contact the Recalling Firm's National Technical Support at: Toll Free: (844)487-2767 available 8:00 a.m. to 5:00 p.m. Monday thru Friday On 01/07/2022, an updated "Urgent: Voluntary Medical Device Recall Letter" will be communicated to customer to provide additional instruction on how to identify an issue with their system which would indicated to cease using until the system has been corrected.
• Quantity in Commerce: 28 systems
• Distribution: U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OWB