Class 2 Device Recall SonialVision safire

• Date Initiated by Firm: January 10, 2022
• Create Date: April 07, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0869-2022
• Recall Event ID: 89596
• 510(K)Number: K190373
• Product Classification: System, x-ray, fluoroscopic, image-intensified - Product Code JAA
• Product: MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
• Code Information: Model: SonialVision safire: Generator Number: D150-40 Serial Numbers: 3M5249D41006 3M5249D2A004 3M5249D34001 3M5249D37006 3M5249D32012 3M5249D35002 3M5249D1C013 3M5249D31009 3M5249D29002 3M5249D33003 3M5249D2C004 3M5249D22013
• 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: It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.
• FDA Determined Cause: Software design
• Action: On or about 1/7/2022, the firm sent an "Urgent: Voluntary Medical Device Recall Notice" to customers informing them that there is a potential issue with the adjustment procedure of the generator on the SonialVision (G$ and safire) Systems and FluoroSpeed X1 Systems. As a result of the Recalling Firm's investigation and testing it was proven that there is a problem with the adjustment procedure documented for the calibration of the system xray generator. This problem occurs during the calibration of the fluoroscopic mode which could cause x-ray radiation dose rate to exceed regulation and/or standards. As a result of the investigation, it was determined that the calibration procedure for the generator to instruct the installer requires updating. This problem if not corrected could cause improper calibration which would lead to dose levels above regulations. Therefore, the Recalling Firm will release notification to update calibration instructions and to conduct calibration of the system following revised calibration procedure. Customers are instructed to: -Check their systems for the affected generators/systems. -Contact their distributor to schedule a system update and calibration. -Pay attention to the following points until the calibration/update is completed: If the SID (distance between the X-ray focus and the FPD input surface) is 1200 mm or more, it has been confirmed that the dose rate does not exceed the specified value. If SID 1200 mm cannot be used and SID 1100 mm is used, the following points must be kept in mind until readjustment. When fluoroscopy is performed under the condition where the fluoroscopy tube voltage is maximum, the dose rate may increase by up to 8 percent from the adjustment value at the time of installation and exceed the dose regulation and/or standard value. Therefore, pay attention to the fluoroscopy cumulative time so as not to perform fluoroscopy for a long time under the condition where the fluoroscopy tube voltage is
• Quantity in Commerce: 12 systems
• Distribution: U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, and WV. O.U.S.: N/A
• 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 = JAA and Original Applicant = SHIMADZU corporation