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.
Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or healthcare personnel.
Domestic: LA
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0197-2019