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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 CORPORATION MEDICAL SYSTEMS DIVISION: Trinias Digital Angiography System Recalled for Potential Display Failure

Agency Publication Date: March 14, 2024
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Summary

Shimadzu Corporation is recalling one Trinias Digital Angiography System due to a manufacturing defect in a capacitor within the device. This specific defect can cause the Flat Panel Device to show an abnormal display or stop functioning entirely during medical procedures. The recall affects a single unit with serial number 41EFFF7D3001, which was distributed in Ohio. This system is used for medical imaging during vascular procedures, and a display failure could disrupt critical patient care.

Risk

A faulty capacitor may lead to the sudden loss of the imaging display or provide inaccurate visual data. This poses a risk to patients if the failure occurs during a guided surgical or diagnostic procedure, potentially leading to delays or complications.

What You Should Do

  1. Identify if your facility is using the Shimadzu Trinias Digital Angiography System by checking the serial number and Unique Device Identifier (UDI). The affected unit has Serial Number: 41EFFF7D3001 and UDI: (01)04540217058020.
  2. If you are the operator of this specific unit, contact Shimadzu Corporation Medical Systems Division immediately to coordinate a service visit or repair for the capacitor issue.
  3. Contact your healthcare provider or the manufacturer for further instructions regarding the continued use of the device and any potential remedy or refund options.
  4. For additional questions or to report further issues, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer initiated correction via letter

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Shimadzu, Trinias, Digital Angiography System
Model / REF:
41EFFF7D3001
Lot Numbers:
UDI: (01)04540217058020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93933
Status: Active
Manufacturer: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Sold By: Authorized medical distributors
Manufactured In: Japan
Units Affected: 1
Distributed To: Ohio

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.