Digital Angiography System Shimadzu Trinias Generator
Medical device recall Z-0655-2022. Published in FDA’s Enforcement Report on Mar 9, 2022.
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 Mar 9, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 15 states named in where it went
- 28 systems 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?
Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
28 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Generator Model: D150GC-40 Serial Number Range - 3M99D44446001to LM99D44B8001 Serial Number/SMS ID: 41E58C765001/SMS20160146 41EFCD78B001/SMS20190007 41EFD3B9A001/SMS20200009 41F005CB8001/SMS20210266 41E58C766001/SMS20160150…
Every code shown here, 792 characters
Generator Model: D150GC-40 Serial Number Range - 3M99D44446001to LM99D44B8001 Serial Number/SMS ID: 41E58C765001/SMS20160146 41EFCD78B001/SMS20190007 41EFD3B9A001/SMS20200009 41F005CB8001/SMS20210266 41E58C766001/SMS20160150 41B247746001/SMS20140089 41E58C757001/SMSHP150024 41E58C769001/SMS20160151 41E58C777001/SMS20170121 41EFCD77C001/SMS20180143 41F005B8C001/SMS20190052 41EFCD79A001/SMS20190366 41EFCD79C001/SMS20200285 41EFC73A5001/SMS20200263 41EFCD7A6001/SMS20200267 41EFC73A9001/SMS20200443 41E5E23AA001/SMS20200369 41E58C773001/SMSHP170001 41E58C977001/SMS20170424 41EFFF79A001/SMS20190376 41EFFF79C001/SMS20200031 41EFD3B9C001/SMS20200066 41E58C76B001/SMS20170288 41E58C775001/SMS20170134 41E58C776001/SMS20170135 41F005B91001/SMS20190019 41B24774C001/SMSMA140084 41EFCD7AC001/#N/A
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.
U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided.
The states and territories these words name
15 states and territories.
Every one of them
- California
- Florida
- Georgia
- Illinois
- Indiana
- Kentucky
- Louisiana
- Michigan
- Mississippi
- Ohio
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Washington
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Dec 16, 2021.
- FDA classified it on Feb 27, 2022.
- FDA’s Enforcement Report published it on Mar 9, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Shimadzu Medical Systems, of Torrance, CA.
- Who began it, in FDA’s words: FDA Mandated.
- How the firm first told its customers: Letter.
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.”
- 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.