Digital Angiography System Trinias:UD150G-40 / D150GC-40
Medical device recall Z-2294-2026. Published in FDA’s Enforcement Report on Jun 10, 2026.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 10, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 44 states named
- 3487 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
3487 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
System Serial Numbers:SMS20080542 SMS20120038 SMS20140084 SMS20090038 SMSMA110013 SMS20090239 SMS20080581 SMS20090099 SMS20110202 SMS2010011 SMS20080609 SMS20100127 SMS20090157 SMS20080573 SMS20100230 SMSMA130031 SMS20105020 SMS20080009…
Every code shown here, 2,000 characters
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 SMS20170272 SMS20090054 SMS20060032 SMS20210085 SMS20080133 SMS20080155 SMS20110213 SMS20095208 SMSHP120011 SMS2012008 SMS20120094 SMS20120106 SMS20120107 SMSHP140009 SMSMA150070 SMS20140064 SMS20190264 SMS20100205 SMS20080189 SMS20100205 SMS20080190 SMS20070002 SMS20080162 SMS20100221 SMS20120011 SMS20110186 SMS20140003 SMS20090053 SMS20110139 SMS20095169 SMS20080247 SMS20090154 SMS20090039 SMSHP110007 SMS20200064 SMS20095200 SMS20080061 SMS20090188 SMS20090208 SMSVA090012 SMS20100114 SMS20100126 SMS20090214 SMS20090043 SMSMA110069 SMS20080156 SMS20190259 SMS20080109 SMS20070008 SMS20070001 SMS20210059 SMS20210193 SMS20210278 SMS20210392 SMS20210347 SMS20220070 SMS20220036 SMS20200068 SMS20200330 SMS20220168 SMS20220206 SMS20220299 SMS20220292 SMS20220323 SMS20220360 SMS20230010 SMS20230040 SMS20230071 SMS20230080 SMS20230092 SMS20230180 SMS20230194 SMS20230195 SMS20230217 SMS20230265 SMS20230277 SMS20240004 SMS20240006 SMS20240120 SMS20240206 SMS20200072 SMS20220262 SMS20220264 SMS20230014…
FDA’s list runs to 71,919 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
44 states and territories.
Every one of them
- 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
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 20, 2026.
- FDA classified it on Jun 2, 2026.
- FDA’s Enforcement Report published it on Jun 10, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Shimadzu Medical Systems, of Long Beach, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 71,919 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.