FDA Recall Open, Classified

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

Recall: Z-2294-2026 · Initiated April 20, 2026

Recall

Recall Number: Z-2294-2026
Event Number: 98571
Firm: Shimadzu Medical Systems
FEI Number: 1000125362
Product Code: OWB
Status: Open, Classified
Root Cause: Component design/selection
Initiated: April 20, 2026
Posted: June 2, 2026
Address: 3645 N Lakewood Blvd, Long Beach, CA, 90808-1797

Description

Reason

Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.

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.

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.

Quantity

3487 units