Shimadzu Medical Systems: Interventional Fluoroscopic X-ray System
Recall Summary Shimadzu Medical Systems is recalling multiple models of interventional and diagnostic X-ray systems used in medical facilities because electromagnetic contactors in the high voltage generator may weld together, allowing electrical current to continue flowing to the power supply even when the system is turned off. The affected systems include various models of angiography, radiography, and fluoroscopy equipment distributed nationwide across the US and internationally to Canada, The Bahamas, China, and Denmark. This is classified as a Class II recall, meaning the defect could cause serious adverse health consequences or death.
- Recalling firm
- Shimadzu Medical Systems
- 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:...
- Reason
- Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-20
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/273edbfb-e0b4-4ab1-b524-b2c3573b7a02