Class 2 Device Recall Bransist safire

• Date Initiated by Firm: December 16, 2021
• Create Date: February 28, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0654-2022
• Recall Event ID: 89253
• 510(K)Number: K062360
• Product Classification: System, x-ray, angiographic - Product Code IZI
• Product: Digital Angiography System Bransist safire; ; Generator Model D150GC-40
• Code Information: Generator Model: D150GC-40 Serial Number Range - 0161Q81103 to 3M99D3A55001 Specific Generator Serial Number/SMS ID: 3M99D3A24001/SMS20120038 3M99D3A4B001/SMS20140084 3M99D3A55001/SMS20150030 0161Q83701/SMS20080542 0161Q82204/SMS20080045 0161Q82302/SMS20080043 0161Q82304/SMS20080046 0261Q80901/SMS20100011 3M7A1600B001/SMS20080286 3M99D2622001/SMSMA110079 0161Q84501/SMS20090038 3M7A1600C001/SMS20200285 3M7A16A1A001/SMSMA110013 3M99D3A1C001/SMS20110202 0161Q84103/SMS20090099 0161Q83603/SMS20080505 0161Q83702/SMS20080580 0161Q83703/SMS20080581
• 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: 18
• 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 = IZI and Original Applicant = SHIMADZU CORP.