FDA recall, , Moderate risk
Shimadzu Digital Angiography and Radiography Systems
Digital Angiography Systems and a Digital Radiography System have electromagnetic contactors that may weld together.
Summary by Recall Canary from the FDA notice
What happened
Shimadzu Medical Systems of Long Beach, California, began a recall on April 20, 2026, of 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, Digital Radiography System RADspeed safire, Radiography System RADspeed fit, and X-RAY R/F. The agency stated that electromagnetic contactors within the high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.
The recall was added to the FDA's Enforcement Report and classified on June 2, 2026, and in FDA's weekly enforcement report on June 10, 2026.
The products were distributed worldwide, including nationwide in the U.S. in 44 states and the countries of Canada, The Bahamas, China, Denmark, and Haiti. The recall involved 3487 units.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Product details
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 details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution including in the states of Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and the countries of Canada, The Bahamas, China, Denmark, Haiti.
- Company
- Shimadzu Medical SystemsLong Beach, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98571
- Recall number
- Z-2294-2026
- Quantity recalled
- 3487 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
