Trinias recallZ-1292-2024 · Shimadzu Corporation Medical Systems Division · initiated Jan 29, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Shimadzu Corporation Medical Systems Division or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.
FDA root cause category: Process change control
What the company is doing
On January 29, 2024, Shimadzu Medical Systems USA, issued a "Urgent Voluntary Medical Device Recall Notice to affected consignees. Shimadzu asked consignees to take the following actions: 1. Please check the list of systems affected by this recall. If your site is on the applicable list, please schedule time with your Distributer to have your system updated and calibrated. Shimadzu requests that you post this letter within your facility so that all users are aware that a recall has been issued. 2. Please pay attention to possible issue with images on your systems. If operation is deemed to be non-standard then contact your local service representative so the issue can be investigated. 3. Shimadzu has identified the affected units and informed your authorized service representative. They will be contacting you to schedule a time to implement the corrective action. If you do not receive a call or visit concerning this matter, please contact Shimadzu National Support. 4. Please complete the Customer Acknowledgement receipt of letter form.
Recall details
- Recall number
- Z-1292-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 29, 2024
- Posted by the FDA
- Mar 14, 2024
- Recalling firm
- Shimadzu Corporation Medical Systems Division
- Quantity
- 1
- Product code
- OWB
- FDA submissions
- K123508
- Distribution
- US Nationwide distribution in the states of OH.
Product description
Shimadzu, Trinias, Digital Angiography System
Code information (models, lots, serial numbers)
Serial Number: 41EFFF7D3001/UDI: (01)04540217058020
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Trinias 503-79830-31Shimadzu Corporation · System, X-Ray, Fluoroscopic, Image-Intensified1 recall0 reports
Product lines
Other devices under the same FDA submission
4 devices cleared under K123508 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Trinias 503-79402-31Shimadzu Corporation · System, X-Ray, Fluoroscopic, Image-Intensified1 recall0 reports
- Trinias 503-79402-33Shimadzu Corporation · System, X-Ray, Fluoroscopic, Image-Intensified1 recall0 reports
- Trinias 503-79821-31Shimadzu Corporation · System, X-Ray, Fluoroscopic, Image-Intensified1 recall0 reports
- Trinias 503-79822-31Shimadzu Corporation · System, X-Ray, Fluoroscopic, Image-Intensified1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page