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.
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.
Manufacturer initiated correction via letter
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.
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Sources: FDA iRES ยท Raw API Response
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