Quick Facts at a Glance
- Recall Date
- April 20, 2026
- Hazard Level
- HIGH
- Brand
- Shimadzu Medical Systems
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Shimadzu Medical Systems
- Model numbers
- System Serial Numbers:SMS20080542 SMS20120038 SMS20140084 SMS20090038 SMSMA110013 SMS20090239 SMS20080581 SMS20090099 SMS20110202 SMS2010011 SMS20080609 SMS20100127 SMS20090157 SMS20080573 SMS20100230 SMSMA130031 SMS20105020 SMS20080009 SMS20080174 SMS20090316 SMS20090281 SMSMA100027 SMSHP100002 SMSHP100001 SMS20100007 SMSHP100013 SMS20100068 SMS20100010 SMSBL110013 SMSMA120007 SMSNO130066 SMSHP110014 SMSMA130015 SMSPR130007 SMSBL120003 SMSMA110022 SMSNO120020 SMS20130105 SMS20160046 SMSVZ160014 SMS20080264 SMS20170160 SMS20160049 SMS20080358 SMS20080519 SMS20080238 SMS20080135 SMS20080493 SMS20090134 SMS20085122 SMS20070007 SMS20070013 SMS20095174 SMS20080128 SMS20210210 SMS20080283 SMS20080284 SMS20080154 SMS20170211 SMS20080091 SMSHP110015 SMS20090136 SMS20120069 SMS20120023 SMSMA140083 SMS20140060 SMS20080332 SMS20080277 SMS20170376 SMSNO120066 SMS20160121 SMS20090086 SMS20080018 SMS20100098 SMS20100041 SMSBL110001 SMSMA130023 SMSHP130022 SMS20110205 SMS20170164 SMS20180266 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- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
April 20, 2026
Reported by FDA DEVICE
June 10, 2026
RecallRadar source check
June 16, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Shimadzu Medical Systems or your healthcare provider for instructions
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Full Description
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. 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. Quantity: 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.
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