Digital Angiography System Bransist safire Generator
Medical device recall Z-0654-2022. 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
- 18 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 Bransist safire Generator Model D150GC-40
18, 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 - 0161Q81103 to 3M99D3A55001 Specific Generator Serial Number/SMS ID: 3M99D3A24001/SMS20120038 3M99D3A4B001/SMS20140084 3M99D3A55001/SMS20150030 0161Q83701/SMS20080542 0161Q82204/SMS20080045…
Every code shown here, 546 characters
Generator Model: D150GC-40 Serial Number Range - 0161Q81103 to 3M99D3A55001 Specific Generator Serial Number/SMS ID: 3M99D3A24001/SMS20120038 3M99D3A4B001/SMS20140084 3M99D3A55001/SMS20150030 0161Q83701/SMS20080542 0161Q82204/SMS20080045 0161Q82302/SMS20080043 0161Q82304/SMS20080046 0261Q80901/SMS20100011 3M7A1600B001/SMS20080286 3M99D2622001/SMSMA110079 0161Q84501/SMS20090038 3M7A1600C001/SMS20200285 3M7A16A1A001/SMSMA110013 3M99D3A1C001/SMS20110202 0161Q84103/SMS20090099 0161Q83603/SMS20080505 0161Q83702/SMS20080580 0161Q83703/SMS20080581
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.