TriniasRecalls & reported problems across all models
Shimadzu Corporation · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Trinias model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 3
We found 5 models of Trinias by Shimadzu Corporation in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
3 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Trinias recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 6, 2024Class IIOpen, Classified
If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.
Z-0139-2025 · Root cause: Software Design Change · names 3 of these models · Recall details · FDA record ↗
- Jan 29, 2024Class IIOpen, Classified
Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.
Z-1292-2024 · Root cause: Process change control · Recall details · FDA record ↗
- Jun 15, 2018Class IITerminated
Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or healthcare personnel.
Z-0197-2019 · Root cause: Software design · Recall details · FDA record ↗
Trinias models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Trinias 503-79402-31System, X-Ray, Fluoroscopic, Image-Intensified1 recall0 reports
- Trinias 503-79402-33System, X-Ray, Fluoroscopic, Image-Intensified1 recall0 reports
- Trinias 503-79830-31System, X-Ray, Fluoroscopic, Image-Intensified1 recall0 reports
- Trinias 503-79821-31System, X-Ray, Fluoroscopic, Image-Intensified1 recall0 reports
- Trinias 503-79822-31System, X-Ray, Fluoroscopic, Image-Intensified1 recall0 reports
Other Shimadzu Corporation products
All Shimadzu Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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