Shimadzu TRINIAS Digital Angiographic System Recalled for C-Arm Movement Issue
Shimadzu is recalling one TRINIAS Digital Angiographic System in Louisiana due to a software issue that may cause the C-arm to move unexpectedly, posing a risk of contact with patients or staff.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where the C-arm may physically contact patients or staff, but the source text does not report any actual injuries or illnesses.
Plain-English summary
Shimadzu Medical Systems USA is recalling one unit of the TRINIAS Digital Angiographic System. This device is intended for cardiac, neurovascular, abdominal, and peripheral angiography, as well as whole-body radiographic and fluoroscopic procedures. The recall is limited to a single unit distributed in Louisiana.
The recall is being conducted due to a software issue that may cause the C-arm to move unexpectedly when being moved to the park position or during specific operations. This malfunction creates a possibility that the C-arm could come into contact with a patient or healthcare personnel.
Healthcare facilities that have this specific unit should contact Shimadzu Medical Systems USA for further instructions on how to address the software issue. The affected unit is identified by Model Trinias, UDI (01)04540217049080(11)170727(21)41E58C977001, and Serial Number 41E58C977001.
The recalled product
- Product
- TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
- Manufacturer
- Shimadzu Medical Systems Usa Com
- Affected units
- 1
Distribution
Distributed in 1 state:
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