Shimadzu Corporation has recalled 13 units of the Trinias unity Digital Angiography System with Catheterization Table (Model KS-100). The recall was issued because the catheterization table may continue to move unintentionally even after the operator releases the movement button. This unintended movement can be stopped by pressing the emergency stop button, but it poses a risk during sensitive medical procedures.
The unintended movement of the surgical table could lead to patient injury or complications during angiography procedures. This defect occurs when the operator attempts to move the table and the C-arm at the same time using the system's direct memory feature. No incidents or injuries have been reported.
System includes C-arm, catheterization table, image processing equipment, x-ray high voltage generator, and x-ray tube.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES ยท Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.