Shimadzu recalls Trinias Unity Digital Angiography Systems with KS-100 catheterization tables due to risk of unintended table movement if operator releases direct memory button during simultaneous table and C-arm movement. Affected units have specific serial numbers and UDI-DI codes.
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.
Shimadzu is recalling Trinias Unity Digital Angiography Systems with KS-100 catheterization tables because a specific movement sequence could cause the table to continue moving after the operator releases the direct memory button. This risk could lead to unintended patient or operator movement if not properly stopped.
If the operator moves both the catheterization table and C-arm simultaneously using direct memory, then releases the direct memory button, the table may continue moving. The operator can stop this movement by pressing the stop button, but the risk exists during the specific movement sequence.
Medical professionals using the Trinias Unity system with KS-100 catheterization tables are most at risk. Patients undergoing procedures with this equipment may also be affected if the table moves unexpectedly.
Check for the model KS-100 catheterization table with the Trinias Unity Digital Angiography System. Affected units have specific serial numbers: 41EFCD7AC001, 41E58C773001, 41EFCD79C001, 41EFCD78B001, 41EFC73A9001, 41EFCD7D4001, 41E58C76B001, 41EFC73D9001, 41EFCD77C001, 41EFC73A5001, 41EFC73C5001, 41EFCD79A0001, 41EFCD7A6001. UDI-DI codes: 04540217058327, 04540217049066, 04540217058143.
Verify if your system includes the KS-100 catheterization table with the Trinias Unity Digital Angiography System.
If the table continues moving after releasing the direct memory button, press the stop button immediately to halt movement.
If the operator moves both the catheterization table and C-arm simultaneously using direct memory, then releases the direct memory button, the table may continue moving. The operator can stop this movement by pressing the stop button.
Check for the model KS-100 catheterization table with the Trinias Unity Digital Angiography System. Affected units have specific serial numbers: 41EFCD7AC001, 41E58C773001, 41EFCD79C001, 41EFCD78B001, 41EFC73A9001, 41EFCD7D4001, 41E58C76B001, 41EFC73D9001, 41EFCD77C001, 41EFC73A5001, 41EFC73C5001, 41EFCD79A001, 41EFCD7A6001. UDI-DI codes: 04540217058327, 04540217049066, 04540217058143.
The recall does not specify a remedy, so you should check if the system is moving unexpectedly and stop it by pressing the stop button if needed.
We’ve drafted a message you can send Shimadzu to request your refund or repair — edit it as you like.
Subject: Recall Z-0139-2025 — Shimadzu Shimadzu Hello, I own a Shimadzu that is covered by recall Z-0139-2025 from Shimadzu. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
