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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

FDA Recall Z-2294-2026 · Posted 2026-06-02

Recalling FirmShimadzu Medical Systems
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2026-04-20
Product Quantity3487 units

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.

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K233722RADspeed ProShimadzu Corporation · 2024-02-23K221922TriniasShimadzu Corporation Medical Systems Division · 2022-07-28K203535TriniasShimadzu Corporation Medical Systems · 2021-04-28K152244RADspeed ProShimadzu Corporation · 2016-06-20K062360BRANSIST SAFIREShimadzu Corp. · 2006-10-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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