Shimadzu Medical Systems Usa Com recalls TRINIAS Digital Angiographic System intended to be used for
Recalled 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.
Hazard / Issue
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.
Issued by
FDA
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