Shimadzu D150GC-40 Digital Angiography System Recall: X-ray Radiation Risk
Shimadzu recalls D150GC-40 Digital Angiography Systems with serial numbers 0161Q81103 to 3M99D3A55001 due to potential x-ray radiation dose rate exceeding safety limits in fluoroscopic mode.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Shimadzu is recalling specific Digital Angiography Systems with model D150GC-40 and certain serial numbers because improper installation could cause x-ray radiation to exceed safe levels during fluoroscopy. This poses a risk of unnecessary radiation exposure to patients or staff during medical procedures. Read more at govinfonow.com/recall/61422-shimadzu-d150gc-40-digital-angiography-system-recall-x-ray-radiation.
Source Summary by GovInfoNow · govinfonow.com/recall/61422-shimadzu-d150gc-40-digital-angiography-system-recall-x-ray-radiation · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0654-2022
Cite this page
“Shimadzu D150GC-40 Digital Angiography System Recall: X-ray Radiation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61422-shimadzu-d150gc-40-digital-angiography-system-recall-x-ray-radiation. Based on FDA recall #Z-0654-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0654-2022%22&limit=1).
Why it’s dangerous
The system's inadequate installation criteria may cause x-ray radiation dose rates to exceed safe limits when used in fluoroscopic mode. This could lead to unnecessary radiation exposure for patients and medical personnel during imaging procedures.
Who’s affected
Medical facilities using the D150GC-40 generator with the listed serial numbers are most at risk. Patients and medical staff during procedures using these systems could be exposed to higher-than-safe radiation levels.
How to tell if you have this one
Check if your Digital Angiography System has the model D150GC-40 and a serial number in the range 0161Q81103 to 3M99D3A55001. The specific serial numbers listed include 3M99D3A24001, 3M99D3A4B001, and others.
- Brand
Shimadzu Medical Systems- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0654-2022 | Digital Angiography System Bransist safire Generator Model D150GC-40; 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 | 18 |
| Z-0655-2022 | Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40; 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 | 28 systems |
What to do — step by step
Check Serial Numbers
Verify your generator's serial number against the list of affected units provided in the recall notice.
Where it went and when
Where it was distributed
Distributed in 15 states.
FDA distribution: “U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Mississippi, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Washington.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0654-2022 (December 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0654-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.