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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Shimadzu Trinias unity Angiography Systems Recalled for Unintended Movement

Agency Publication Date: October 22, 2024
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Summary

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.

Risk

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.

What You Should Do

  1. This recall affects Shimadzu Trinias unity Digital Angiography Systems (Model KS-100) equipped with specific catheterization tables.
  2. Identify if your system is affected by checking the following serial numbers: 41EFCD7AC001, 41E58C773001, 41EFCD79C001, 41EFCD78B001, 41EFC73A9001, 41EFCD7D4001, 41E58C76B001, 41EFC73D9001, 41EFCD77C001, 41EFC73A5001, 41EFC73C5001, 41EFCD79A001, or 41EFCD7A6001.
  3. You can also verify the UDI-DI codes on the device labels: 04540217058327, 04540217049066, or 04540217058143.
  4. Stop using the recalled device and contact Shimadzu Corporation Medical Systems Division or your authorized medical device distributor to arrange for a return, replacement, or technical correction.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for more information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Trinias unity, Digital Angiography System with Catheterization Table
Model / REF:
KS-100
Serial Numbers:
41EFCD7AC001
41E58C773001
41EFCD79C001
41EFCD78B001
41EFC73A9001
41EFCD7D4001
41E58C76B001
41EFC73D9001
41EFCD77C001
41EFC73A5001
41EFC73C5001
41EFCD79A001
41EFCD7A6001
UDI:
04540217058327
04540217049066
04540217058143

System includes C-arm, catheterization table, image processing equipment, x-ray high voltage generator, and x-ray tube.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95406
Status: Active
Manufacturer: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Sold By: Authorized medical device distributors; Hospitals
Manufactured In: Japan
Units Affected: 13
Distributed To: Massachusetts, Illinois, South Carolina, Kentucky, Ohio, Tennessee

Were You Affected by This Recall?

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.

Find an Attorney

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.