Trinias recallZ-0139-2025 · Shimadzu Corporation Medical Systems Division · initiated Sep 6, 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
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.
FDA root cause category: Software Design Change
What the company is doing
On 9/6/24, recall notices were sent to customers who were asked to do the following: 1) Firmware for the system controller requires updating. The work to correct this issue will be performed by your Authorized Service provider. 2) Schedule time with your Distributer to have your system updated. 3) Complete and return the response form to [email protected] Questions can be directed to the firm's National Technical Support: Toll Free: (844)487-2767 Available 8:00 to 5:00 PM, Monday - Friday
Recall details
- Recall number
- Z-0139-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 6, 2024
- Posted by the FDA
- Oct 22, 2024
- Recalling firm
- Shimadzu Corporation Medical Systems Division
- Quantity
- 13
- Product code
- OWB
- FDA submissions
- K123508
- Distribution
- US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN.
Product description
Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component.
Code information (models, lots, serial numbers)
UDI-DI: 04540217058327, 04540217049066, 04540217058143 Serial Numbers: 41EFCD7AC001, 41E58C773001, 41EFCD79C001, 41EFCD78B001, 41EFC73A9001, 41EFCD7D4001, 41E58C76B001, 41EFC73D9001, 41EFCD77C001, 41EFC73A5001, 41EFC73C5001, 41EFCD79A001, 41EFCD7A6001.
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Trinias 503-79402-31Shimadzu 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
Product lines
Other devices under the same FDA submission
2 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 503-79402-33Shimadzu Corporation · System, X-Ray, Fluoroscopic, Image-Intensified1 recall0 reports
- Trinias 503-79830-31Shimadzu 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.
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