Class 2 Device Recall Bransist Safire

• Date Initiated by Firm: November 18, 2020
• Create Date: December 10, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0554-2021
• Recall Event ID: 86846
• 510(K)Number: K062360
• Product Classification: System, x-ray, angiographic - Product Code IZI
• Product: Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures.
• Code Information: Serial Numbers: 40AD58C55001, 40AD58C4B001, 40AD58C24001, 40AD58522001, 40AD58C1C001, 101X968101, 091X955901
• Recalling Firm/ Manufacturer: Shimadzu Medical Systems; 20101 S Vermont Ave; Torrance CA 90502-1328
• For Additional Information Contact: Mr. John Goossens; 310-217-8855 Ext. 117
• Manufacturer Reason for Recall: The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
• FDA Determined Cause: Software design
• Action: On 11/18/2020 Shimadzu sent an "Urgent Medical Device Recall Notice" to all affected consignees. In addition to informing consignees about the recall the firm provided the following information. 1. Shimadzu has released a mandatory Service Bulletin on applicable products for the update of the positioner software. The update of the software and the testing of the positioner movement should be performed by your Authorized Shimadzu Service provider. 2. Your authorized Distributor has acknowledged receipt the Service Bulletin (XR-202026) and the recall Customer Letter. They have been instructed to provide you a copy of this letter so that you may understand the scope of the recall. Necessary software for this recall and instruction to complete have been sent to your Distributer and they should be scheduling time to perform the corrective actions. 3. Once the corrective work has been completed your Distributor will report to Shimadzu that the work has been completed so that we may track and inform the appropriate Regulatory Agencies of its completion. Actions to be taken by customer: A. Please check the list of systems affected by this recall. If your site is on the applicable list, please pay attention to the following points until the corrective work has been completed. . (1) This event does not occur in any position other than the Left or Right diagonal position, so please avoid using this product in diagonal positions. (2) When using the product in the Left or Right diagonal position, please use the direct memory function and encourage C-arm operation without using the lever. (3) If the C-arm starts to operate unintentionally, press the red "Stop Switch" button immediately. B. If you feel there is a problem with the c-arm movement, please discontinue use of the system and contact your local service provider. C. Please complete the Medical device Recall Return Response form and submit to drodriguez@shimadzu-usa.com D. Shimadzu
• Quantity in Commerce: 7 units
• Distribution: US Nationwide distribution including in the states of KY, CA, MI, OH, CT, MI, NY, SC, NC,IN, IL, TN, LA, CT, MT.
• 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.