Class 2 Device Recall TRINIAS, BRANSIST SAFIRE, RADspeed Pro

• Date Initiated by Firm: April 20, 2026
• Date Posted: June 02, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2294-2026
• Recall Event ID: 98571
• 510(K)Number: K062360 K123508 K152244 K203535 K221922 K233722
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST alexa:UD150G-40 / D150GC-40; Digital Radiography System RADspeed Pro: UD150B-40 / UD150V-40 / UD150L-40 / UD150L-40E/D150BC-40 / D150VC-40 / D150LC-40 / D150LC-40E/D150BC-41 / D150VC-41 / D150LC-41; Digital Radiography System RADspeed safire: UD150B-40 / D150BC-40; Radiography System RADspeed fit: N/A (Integrated in the system); X-RAY R/F SYSTEM SONIALVISION safire17:UD150B-40 / D150BC-40; X-RAY R/F SYSTEM SONIALVISION safire Plus: UD150B-40 / D150BC-4;0 X-RAY R/F SYSTEM SONIALVISION safire: UD150B-40 / D150BC-40; X-RAY R/F SYSTEM SONIALVISION VERSA: UD150B-40 / UD150V-40 / UD150L-40/D150BC-40 / D150VC-40 / D150LC-40; X-RAY R/F SYSTEM FLUOROspeed 300:UD150B-40 / UD150V-40 / UD150L-40/D150BC-40 / D150VC-40 / D150LC-40; X-RAY R/F SYSTEM SONIALVISION G4:D150BC-40S; X-RAY R/F SYSTEM FLUOROspeed X1:D150BC-40S
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• FEI Number: 1000125362
• Recalling Firm/ Manufacturer: Shimadzu Medical Systems; 3645 N Lakewood Blvd; Long Beach CA 90808-1797
• For Additional Information Contact: Mr. Joseph Zegarelli; 310-217-8855 Ext. 117
• Manufacturer Reason for Recall: Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.
• FDA Determined Cause: Component design/selection
• Action: On April 20, 2026 Shimadzu Medical Systems USA issued a Urgent: Voluntary Medical Device Recall Notification via E-Mail. Shimadzu asked consignees to take the following actions: 1. If your site is on the applicable list, please schedule time with your Distributer to have your system updated. 2. Shimadzu requests that you post this letter within your facility so that all users are aware of how to avoid this issue until the corrective actions have been completed. 3. If there are any issues, please report them to your respected distributor. 4. Please complete the acknowledgement form below. 5. For additional safety measures, please see customer notification.
• Quantity in Commerce: 3487 units
• Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Canada, The Bahamas, China, Denmark, Haiti.
• 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; 510(K)s with Product Code = OWB; 510(K)s with Product Code = OWB; 510(K)s with Product Code = OWB