Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography Recalled by Shimadzu Medical Systems Usa Com Due to Two issues: Event 1: Normal operation of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Shimadzu Medical Systems Usa Com directly.
Affected Products
TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
Quantity: 13 units
Why Was This Recalled?
Two issues: Event 1: Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure. Event 2: In rare cases a synchronization error may occur in the data transmission circuit in the device due to external noise. The visibility of the displayed image may be corrupted (images become bit-shifted abnormal images). If this event occurs, it may become difficult to see the object, which may hinder the examination and treatment.
Where Was This Sold?
This product was distributed to 9 states: CT, FL, IL, LA, MS, MT, OH, SC, TX
About Shimadzu Medical Systems Usa Com
Shimadzu Medical Systems Usa Com has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report